| Primary | Change in PTSD Severity as Measured by the PTSD Checklist (PCL-5) | The PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline to three weeks (the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. | | OG001 | Sham rTMS to the Right DLPFC | Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
| | | Title | Denominators | Categories |
|---|
| baseline | - ParticipantsOG00055
- ParticipantsOG00158
| |
| |
| Secondary | Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9) | The PHQ-9 is a brief, 9-item scale that includes only the depression-related items from the PHQ. The PHQ-9 has been validated for use in primary care settings and can be used to make a tentative diagnosis of depression and to monitor depression severity and response to treatment in the past 2 weeks. Higher scores indicate increasing depressive symptoms. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Remission from severe depression is defined as a PHQ-9 score less than or equal to 14. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline to three weeks (the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to the Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. In this arm, active rTMS will be delivered at 20 Hertz (Hz) in 2 sec trains with 28 sec inter-train intervals, 20 minutes/session (i.e. 1,600 pulses/session), 7 days/week; 20 consecutive days. Active repetitive transcranial magnetic stimulation: The MagPro R30 is an advanced, high performance magnetic stimulator designed primarily for non-invasive clinical use. The non-invasive brain stimulation system will be used to deliver active repetitive electromagnetic pulses in this research study's treatment of post-traumatic stress disorder. robotic arm: This robotic system is based on a commercially available neurosurgical robot. The robot is mounted on a mobile (i.e. retractable wheels) cart which holds the robot controller and the TMS power supply and pulse-generation computer. The robotic system w |
|
| Secondary | Change in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS) | The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6 and the overall score ranges from 0 to 60. Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline to three weeks (the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to the Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. In this arm, active rTMS will be delivered at 20 Hertz (Hz) in 2 sec trains with 28 sec inter-train intervals, 20 minutes/session (i.e. 1,600 pulses/session), 7 days/week; 20 consecutive days. Active repetitive transcranial magnetic stimulation: The MagPro R30 is an advanced, high performance magnetic stimulator designed primarily for non-invasive clinical use. The non-invasive brain stimulation system will be used to deliver active repetitive electromagnetic pulses in this research study's treatment of post-traumatic stress disorder. robotic arm: This robotic system is based on a commercially available neurosurgical robot. The robot is mounted on a mobile (i.e. retractable wheels) cart which holds the robot controller and the TMS power supply and pulse-generation computer. The robotic system w |
|
| Secondary | Change in PTSD Severity as Measured by the PTSD Checklist for DSM-5 (PCL-5) | The PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline to seven weeks (four weeks after the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. | | OG001 | Sham rTMS to the Right DLPFC | Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
|
| Secondary | Change in PTSD Severity as Measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) | The CAPS-5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. The assessor combines information about frequency and intensity of an item into a single severity rating. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms; the range of the scores is 0-80; with a higher score indicating a higher incidence of PTSD symptoms. To meet criteria for PTSD, a patient must have:
- A traumatic event
- At least one "Re-experiencing" symptom
- At least one "Avoidance" symptom
- At least two "Negative alterations in cognitions and mood" symptoms
- At least two "Alterations in arousal and reactivity" symptoms
- The trauma must last at least a month
- The trauma must cause impairment
| Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline to seven weeks (four weeks after the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. | |
|
| Secondary | Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9) | The PHQ-9 is a brief, 9-item scale that includes only the depression-related items from the PHQ. The PHQ-9 has been validated for use in primary care settings and can be used to make a tentative diagnosis of depression and to monitor depression severity and response to treatment in the past 2 weeks. Higher scores indicate increasing depressive symptoms. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Remission from severe depression is defined as a PHQ-9 score less than or equal to 14. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline to seven weeks (four weeks after the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. | | OG001 | Sham rTMS to the Right DLPFC | Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
|
| Secondary | Change in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS) | The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6 and the overall score ranges from 0 to 60. Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline to seven weeks (four weeks after the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. | | OG001 | Sham rTMS to the Right DLPFC | Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
|
| Secondary | Change in PTSD Severity as Measured by the PTSD Checklist for DSM-5 (PCL-5) | PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. | | OG001 | Sham rTMS to the Right DLPFC | Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
|
| Secondary | Change in PTSD Severity as Measured by the Clinician-Administered PTSD Scale (CAPS-5) | The CAPS-5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. The assessor combines information about frequency and intensity of an item into a single severity rating. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms; the range of the scores is 0-80; with a higher score indicating a higher incidence of PTSD symptoms. To meet criteria for PTSD, a patient must have:
- A traumatic event
- At least one "Re-experiencing" symptom
- At least one "Avoidance" symptom
- At least two "Negative alterations in cognitions and mood" symptoms
- At least two "Alterations in arousal and reactivity" symptoms
- The trauma must last at least a month
- The trauma must cause impairment
| Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. | |
|
| Secondary | Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9) | The PHQ-9 is a brief, 9-item scale that includes only the depression-related items from the PHQ. The PHQ-9 has been validated for use in primary care settings and can be used to make a tentative diagnosis of depression and to monitor depression severity and response to treatment in the past 2 weeks. Higher scores indicate increasing depressive symptoms. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Remission from severe depression is defined as a PHQ-9 score less than or equal to 14. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. | | OG001 | Sham rTMS to the Right DLPFC | Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
|
| Secondary | Change in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS) | The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6 and the overall score ranges from 0 to 60. Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. | | OG001 | Sham rTMS to the Right DLPFC | Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
|
| Secondary | Clinically Significant Response as Measured by the PTSD Checklist for DSM-5 (PCL-5) | The PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD. A clinically significant response is defined as a 10-20 point decrease in the PCL-5 scores. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Mean | Standard Error | percentage of change from baseline | | Baseline to three weeks (the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. | | OG001 | Sham rTMS to the Right DLPFC | Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
|
| Secondary | Clinically Significant Response in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9) | The PHQ-9 is a brief, 9-item scale that includes only the depression-related items from the PHQ. The PHQ-9 has been validated for use in primary care settings and can be used to make a tentative diagnosis of depression and to monitor depression severity and response to treatment in the past 2 weeks. Higher scores indicate increasing depressive symptoms. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Remission from severe depression is defined as a PHQ-9 score less than or equal to 14. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Mean | Standard Error | percentage of change from baseline | | Baseline to three weeks (the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. | | OG001 | Sham rTMS to the Right DLPFC | Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
|
| Secondary | Clinically Significant Response in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS) | The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6 and the overall score ranges from 0 to 60. Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression. Clinically significant response is defined as greater than or equal to a 50% decrease in the MADRS score. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Mean | Standard Error | percentage of change from baseline | | Baseline to three weeks (the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. | | OG001 | Sham rTMS to the Right DLPFC | Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
|
| Secondary | Clinically Significant Response as Measured by the PTSD Checklist for DSM-5 (PCL-5) | The PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD. A clinically significant response is defined as a 10-20 point decrease in the PCL-5 scores. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Mean | Standard Error | percentage of change from baseline | | Baseline to seven weeks (four weeks after the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. | | OG001 | Sham rTMS to the Right DLPFC | Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
|
| Secondary | Clinically Significant Response as Measured by the Clinician-Administered PTSD Scale (CAPS-5) | The CAPS-5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. The assessor combines information about frequency and intensity of an item into a single severity rating. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms; the range of the scores is 0-80; with a higher score indicating a higher incidence of PTSD symptoms. To meet criteria for PTSD, a patient must have:
- A traumatic event
- At least one "Re-experiencing" symptom
- At least one "Avoidance" symptom
- At least two "Negative alterations in cognitions and mood" symptoms
- At least two "Alterations in arousal and reactivity" symptoms
- The trauma must last at least a month
- The trauma must cause impairment
A clinically significant response is defined as at least a 50% decrease in the CAPS-5. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Mean | Standard Error | percentage of change from baseline | | Baseline to seven weeks (four weeks after the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
|
| Secondary | Clinically Significant Response in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9) | The PHQ-9 is a brief, 9-item scale that includes only the depression-related items from the PHQ. The PHQ-9 has been validated for use in primary care settings and can be used to make a tentative diagnosis of depression and to monitor depression severity and response to treatment in the past 2 weeks. Higher scores indicate increasing depressive symptoms. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Remission from severe depression is defined as a PHQ-9 score less than or equal to 14. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Mean | Standard Error | percentage of change from baseline | | Baseline to seven weeks (four weeks after the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. | | OG001 | Sham rTMS to the Right DLPFC | Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
|
| Secondary | Clinically Significant Response in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS) | The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6 and the overall score ranges from 0 to 60. Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression. Clinically significant response is defined as greater than or equal to a 50% decrease in the MADRS score. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Mean | Standard Error | percentage of change from baseline | | Baseline to seven weeks (four weeks after the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. | | OG001 | Sham rTMS to the Right DLPFC | Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
|
| Secondary | Clinically Significant Response as Measured by the PTSD Checklist for DSM-5 (PCL-5) | The PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD. A clinically significant response is defined as a 10-20 point decrease in the PCL-5 scores. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Mean | Standard Error | percentage of change from baseline | | Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. | | OG001 | Sham rTMS to the Right DLPFC | Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
|
| Secondary | Clinically Significant Response as Measured by the Clinician-Administered PTSD Scale (CAPS-5) | The CAPS-5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. The assessor combines information about frequency and intensity of an item into a single severity rating. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms; the range of the scores is 0-80; with a higher score indicating a higher incidence of PTSD symptoms. To meet criteria for PTSD, a patient must have:
- A traumatic event
- At least one "Re-experiencing" symptom
- At least one "Avoidance" symptom
- At least two "Negative alterations in cognitions and mood" symptoms
- At least two "Alterations in arousal and reactivity" symptoms
- The trauma must last at least a month
- The trauma must cause impairment
A clinically significant response is defined as at least a 50% decrease in the CAPS-5. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Mean | Standard Error | percentage of change from baseline | | Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
|
| Secondary | Clinically Significant Response in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9) | The PHQ-9 is a brief, 9-item scale that includes only the depression-related items from the PHQ. The PHQ-9 has been validated for use in primary care settings and can be used to make a tentative diagnosis of depression and to monitor depression severity and response to treatment in the past 2 weeks. Higher scores indicate increasing depressive symptoms. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Remission from severe depression is defined as a PHQ-9 score less than or equal to 14. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Mean | Standard Error | percentage of change from baseline | | Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. | | OG001 | Sham rTMS to the Right DLPFC | Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
|
| Secondary | Clinically Significant Response in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS) | The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6 and the overall score ranges from 0 to 60. Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression. Clinically significant response is defined as greater than or equal to a 50% decrease in the MADRS score. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Mean | Standard Error | percentage of change from baseline | | Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. | | OG001 | Sham rTMS to the Right DLPFC | Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
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| Secondary | Remission From PTSD as Measured by the PTSD Checklist for DSM-5 (PCL-5) | The PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD. Remission is defined as a PCL-5 score less than or equal to 33. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Number | | percentage of patients remitted | | Baseline to three weeks (the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. | | OG001 | Sham rTMS to the Right DLPFC | Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
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| Secondary | Remission From Depression as Measured by the 9-item Patient Health Questionnaire (PHQ-9) | The PHQ-9 is a brief, 9-item scale that includes only the depression-related items from the PHQ. The PHQ-9 has been validated for use in primary care settings and can be used to make a tentative diagnosis of depression and to monitor depression severity and response to treatment in the past 2 weeks. Higher scores indicate increasing depressive symptoms. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Remission from severe depression is defined as a PHQ-9 score less than or equal to 14. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Number | | percentage of patients remitted | | Baseline to three weeks (the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. | | OG001 | Sham rTMS to the Right DLPFC | Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
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| Secondary | Remission From Depression as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS) | The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6 and the overall score ranges from 0 to 60. Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression. Remission from depression is defined as a MADRS score less than or equal to 10. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Number | | percentage of patients remitted | | Baseline to three weeks (the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. | | OG001 | Sham rTMS to the Right DLPFC | Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
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| Secondary | Remission From PTSD as Measured by the PTSD Checklist for DSM-5 (PCL-5) | The PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD. Remission is defined as a PCL-5 score less than or equal to 33. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Number | | percentage of patients remitted | | Baseline to seven weeks (four weeks after the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. | | OG001 | Sham rTMS to the Right DLPFC | Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
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| Secondary | Remission From PTSD as Measured by the Clinician-Administered PTSD Scale (CAPS-5) | The CAPS-5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. The assessor combines information about frequency and intensity of an item into a single severity rating. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms; the range of the scores is 0-80; with a higher score indicating a higher incidence of PTSD symptoms. To meet criteria for PTSD, a patient must have:
- A traumatic event
- At least one "Re-experiencing" symptom
- At least one "Avoidance" symptom
- At least two "Negative alterations in cognitions and mood" symptoms
- At least two "Alterations in arousal and reactivity" symptoms
- The trauma must last at least a month
- The trauma must cause impairment
Remission is defined as a CAPS-5 score less than or equal to 29. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Number | | percentage of patients remitted | | Baseline to seven weeks (four weeks after the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
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| Secondary | Remission From Depression as Measured by the 9-item Patient Health Questionnaire (PHQ-9) | The PHQ-9 is a brief, 9-item scale that includes only the depression-related items from the PHQ. The PHQ-9 has been validated for use in primary care settings and can be used to make a tentative diagnosis of depression and to monitor depression severity and response to treatment in the past 2 weeks. Higher scores indicate increasing depressive symptoms. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Remission from severe depression is defined as a PHQ-9 score less than or equal to 14. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Number | | percentage of patients remitted | | Baseline to seven weeks (four weeks after the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. | | OG001 | Sham rTMS to the Right DLPFC | Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
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| Secondary | Remission From Depression as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS) | The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6 and the overall score ranges from 0 to 60. Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression. Remission from depression is defined as a MADRS score less than or equal to 10. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Number | | percentage of patients remitted | | Baseline to seven weeks (four weeks after the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. | | OG001 | Sham rTMS to the Right DLPFC | Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
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| Secondary | Remission From PTSD as Measured by the PTSD Checklist for DSM-5 (PCL-5) | The PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD. Remission is defined as a PCL-5 score less than or equal to 33. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Number | | percentage of patients remitted | | Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. | | OG001 | Sham rTMS to the Right DLPFC | Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
|
| Secondary | Remission From PTSD as Measured by the Clinician-Administered PTSD Scale (CAPS-5) | The CAPS-5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. The assessor combines information about frequency and intensity of an item into a single severity rating. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms; the range of the scores is 0-80; with a higher score indicating a higher incidence of PTSD symptoms. To meet criteria for PTSD, a patient must have:
- A traumatic event
- At least one "Re-experiencing" symptom
- At least one "Avoidance" symptom
- At least two "Negative alterations in cognitions and mood" symptoms
- At least two "Alterations in arousal and reactivity" symptoms
- The trauma must last at least a month
- The trauma must cause impairment
Remission is defined as a CAPS-5 score less than or equal to 29. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Number | | percentage of patients remitted | | Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
|
| Secondary | Remission From Depression as Measured by the 9-item Patient Health Questionnaire (PHQ-9) | The PHQ-9 is a brief, 9-item scale that includes only the depression-related items from the PHQ. The PHQ-9 has been validated for use in primary care settings and can be used to make a tentative diagnosis of depression and to monitor depression severity and response to treatment in the past 2 weeks. Higher scores indicate increasing depressive symptoms. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Remission from severe depression is defined as a PHQ-9 score less than or equal to 14. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Number | | percentage of patients remitted | | Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. | | OG001 | Sham rTMS to the Right DLPFC | Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
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| Secondary | Remission From Depression as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS) | The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6 and the overall score ranges from 0 to 60. Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression. Remission from depression is defined as a MADRS score less than or equal to 10. | Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (>10 sessions). | Posted | | Number | | percentage of patients remitted | | Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. | | OG001 | Sham rTMS to the Right DLPFC | Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
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| Secondary | Functional Connectivity Changes (Measured by Resting-state Functional Magnetic Resonance Imaging) of the Targeted Brain Network(s) Following rTMS Treatment | Resting-state brain networks were identified using functional Magnetic Resonance Imaging. Any changes in the the targeted brain network (e.g. the sub-genual cingulate cortex) were reported using functional connectivity Z-scores. Functional connectivity Z-score indicates the number of standard deviations away from the baseline mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean, and lower connectivity, and positive numbers indicate values higher than the baseline mean, and higher connectivity | Functional brain connectivity to the sub-genual cingulate (SGC) cortex compared between the Active and Sham groups (in participants with >15 treatment sessions) at baseline and 3 weeks. | Posted | | Number | | z-score | | Baseline to three weeks (the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. | | OG001 | Sham rTMS to the Right DLPFC | Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events | This measure counts the number of participants with adverse events and serious adverse events. | | Posted | | Count of Participants | | Participants | | Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment) | | | | ID | Title | Description |
|---|
| OG000 | Active rTMS to Right DLPFC | Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. | | OG001 | Sham rTMS to the Right DLPFC | Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. |
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