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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH119318 | U.S. NIH Grant/Contract | View source |
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Investigator departed from institution
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This is an open-label extension study to continue to evaluate the safety, tolerability and efficacy of the Repetitive Transcranial Magnetic Stimulation (rTMS) in subjects with schizophrenia or schizoaffective disorder who previously completed the treatment study of the protocol #8116 (NCT05319080). Protocol #8116 investigates the clinical efficacy of open-label individualized MRI-guided TMS applied to the left temporoparietal junction (TPJ) in schizophrenia patients. Participating patients who have completed the 4-week project #8116 can be screened for eligibility for this extension study in which they will continue treatment/assessment. They will be divided into three groups (non-responders, partial responders, or full responders) based on a reduction in the Auditory Hallucination Rating Scale (AHRS) scores from the study #8116.
The optimal neuroanatomical treatment targets remain unclear, though current neuroscience evidence suggests several brain areas such as the left temporo-parietal junction area (TPJ) or the right posterior superior temporal sulcus (rSTS) may be involved in the generation and development of AVH. During this extension study, non-responders to protocol #8116 will be administered 10 days (10 sessions) of MRI-guided 1 Hz rTMS delivered to the rSTS instead of the original target in TPJ. Partial responders will receive 10 additional low-frequency rTMS over the original left TPJ target. Like the protocol #8116, the investigators will use the MRI-guided targeting approach during rTMS treatment sessions to achieve greater precision as it can account for individual differences in anatomy. Complete responders will instead be followed for sustainability of response. Their clinical ratings will be repeated at one week, two week, four week and eight week follow-ups. Non-responders are defined as patients showing a reduction of AHRS less than 20% of the initial score. A partial response is defined as a reduction in a range of between 20% and 50% of the initial AHRS score. A complete response is defined as a reduction by at least 50% of the initial AHRS score.The combined outcome of protocol #8116 and the currently proposed protocol will help guide TMS targeting and the number of treatment sessions for a future larger randomized, double-blinded, shame-controlled clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-responders undergo rTMS of the right superior temporal sulcus (STS) | Experimental | Non-responders to protocol #8116 will receive a type of TMS called repetitive TMS (rTMS) wherein the magnetic pulses delivered will be close together in a rapid sequence. They will be administered 10 days (10 sessions) of MRI-guided 1 Hz rTMS delivered to the right superior temporal sulcus (STS). The rTMS parameters that will be used are a frequency of 1 Hz (1 pulse per second) at an intensity of 90% of the motor threshold (MT). Therefore, the investigators will deliver 1200 continuous pulses per session/day which adds up to 12,000 pulses in total for the whole treatment. |
|
| Partial responders undergo rTMS of the left temporo-parietal junction (TPJ) | Experimental | Partial responders to protocol #8116 will receive a type of TMS called repetitive TMS (rTMS) wherein the magnetic pulses delivered will be close together in a rapid sequence. They will be administered 10 days (10 sessions) of MRI-guided 1 Hz rTMS delivered to the original left temporo-parietal junction (TPJ) target. The rTMS parameters that will be used are a frequency of 1 Hz (1 pulse per second) at an intensity of 90% of the motor threshold (MT). Therefore, the investigators will deliver 1200 continuous pulses per session/day which adds up to 12,000 pulses in total for the whole treatment. |
|
| Complete responders undergo four follow-up clinical assessments | No Intervention | Complete responders to protocol #8116 will be offered followup clinical assessments at 1, 2, 4, and 8 weeks to assess sustainability of their response. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS) | Device | During the rTMS session, an electromagnetic coil is placed on the scalp of the subject's head. The electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the region of the brain involved in speech perception. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of rTMS Sessions Completed | The total number of rTMS sessions completed for non responders and partial responders. A session is defined as 20 minutes of rTMS. | 2 weeks. |
| Total Number of Follow-up Clinical Assessments Completed | The total number of follow-up clinical assessments completed for complete responders. A clinical assessment refers to answering questions about psychiatric symptoms to assess the sustainability of the patient's improvement from the previous study. | 8 weeks |
| Total Number of Treatment Emergent Adverse Events | The total number of treatment emergent adverse events for non responders and partial responders. An emergent adverse event is defined as any rTMS risk induced incident in research such as headache and seizure. | 2 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Auditory Hallucination Rating Scale (AHRS) | The AHRS is an investigator-administered scale assessing multiple characteristics of auditory verbal hallucinations. The total score ranges from 2 to 41, with higher scores indicating more severe symptoms. | Up to 4/8 weeks. |
| Change in Psychotic Symptom Rating Scale (PSYRATS) |
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For non responders and partial responders:
Inclusion Criteria:
Exclusion Criteria:
For complete responders:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Avissar, MD, PhD | New York State Psychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-responders Undergo rTMS of the Right Superior Temporal Sulcus (STS) | Non-responders to protocol #8116 will receive a type of TMS called repetitive TMS (rTMS) wherein the magnetic pulses delivered will be close together in a rapid sequence. They will be administered 10 days (10 sessions) of MRI-guided 1 Hz rTMS delivered to the right superior temporal sulcus (STS). The rTMS parameters that will be used are a frequency of 1 Hz (1 pulse per second) at an intensity of 90% of the motor threshold (MT). Therefore, the investigators will deliver 1200 continuous pulses per session/day which adds up to 12,000 pulses in total for the whole treatment. Repetitive Transcranial Magnetic Stimulation (rTMS): During the rTMS session, an electromagnetic coil is placed on the scalp of the subject's head. The electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the region of the brain involved in speech perception. |
| FG001 | Partial Responders Undergo rTMS of the Left Temporo-parietal Junction (TPJ) | Partial responders to protocol #8116 will receive a type of TMS called repetitive TMS (rTMS) wherein the magnetic pulses delivered will be close together in a rapid sequence. They will be administered 10 days (10 sessions) of MRI-guided 1 Hz rTMS delivered to the original left temporo-parietal junction (TPJ) target. The rTMS parameters that will be used are a frequency of 1 Hz (1 pulse per second) at an intensity of 90% of the motor threshold (MT). Therefore, the investigators will deliver 1200 continuous pulses per session/day which adds up to 12,000 pulses in total for the whole treatment. Repetitive Transcranial Magnetic Stimulation (rTMS): During the rTMS session, an electromagnetic coil is placed on the scalp of the subject's head. The electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the region of the brain involved in speech perception. |
| FG002 | Complete Responders Undergo Four Follow-up Clinical Assessments | Complete responders to protocol #8116 will be offered followup clinical assessments at 1, 2, 4, and 8 weeks to assess sustainability of their response. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-responders Undergo rTMS of the Right Superior Temporal Sulcus (STS) | Non-responders to protocol #8116 will receive a type of TMS called repetitive TMS (rTMS) wherein the magnetic pulses delivered will be close together in a rapid sequence. They will be administered 10 days (10 sessions) of MRI-guided 1 Hz rTMS delivered to the right superior temporal sulcus (STS). The rTMS parameters that will be used are a frequency of 1 Hz (1 pulse per second) at an intensity of 90% of the motor threshold (MT). Therefore, the investigators will deliver 1200 continuous pulses per session/day which adds up to 12,000 pulses in total for the whole treatment. Repetitive Transcranial Magnetic Stimulation (rTMS): During the rTMS session, an electromagnetic coil is placed on the scalp of the subject's head. The electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the region of the brain involved in speech perception. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | As N=1 for each arm, the baseline charactertistics are not being disclosed to protect the confidentiality of the participants. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Number of rTMS Sessions Completed | The total number of rTMS sessions completed for non responders and partial responders. A session is defined as 20 minutes of rTMS. | Zero participants analyzed as n=1 for each arm. Results are not included here to protect the confidentiality of the participants. | Posted | 2 weeks. |
|
Up to 8 weeks
As n=1 per arm, data is not disclosed to protect participant confidentiality.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-responders Undergo rTMS of the Right Superior Temporal Sulcus (STS) | Non-responders to protocol #8116 will receive a type of TMS called repetitive TMS (rTMS) wherein the magnetic pulses delivered will be close together in a rapid sequence. They will be administered 10 days (10 sessions) of MRI-guided 1 Hz rTMS delivered to the right superior temporal sulcus (STS). The rTMS parameters that will be used are a frequency of 1 Hz (1 pulse per second) at an intensity of 90% of the motor threshold (MT). Therefore, the investigators will deliver 1200 continuous pulses per session/day which adds up to 12,000 pulses in total for the whole treatment. Repetitive Transcranial Magnetic Stimulation (rTMS): During the rTMS session, an electromagnetic coil is placed on the scalp of the subject's head. The electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the region of the brain involved in speech perception. |
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The study ended prematurely, resulting in a sample size that did not meet our expectations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Avissar | New York State Psychiatric Institute | (646) 774-5431 | MichaelAvissarMDPhD@gmail.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 16, 2023 | Feb 15, 2024 | Prot_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 20, 2022 | Aug 25, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D006212 | Hallucinations |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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Schizophrenia patients with AVH who have completed protocol #8116 will be recruited, and allocated to one of three arms based on their treatment responsiveness from protocol #8116 which included 10 low-frequency TMS treatment sessions using the TPJ target. Their treatment responsiveness is assessed by the Auditory Hallucination Rating Scale (AHRS) at pre- and post-TMS session. Non-responders will be offered 10 daily sessions of 1-Hz rTMS delivered to the rSTS region instead. Partial responders will be offered 10 additional daily sessions of 1-Hz rTMS delivered to the same original left TPJ target used in protocol #8116. Full responders will be offered followup clinical assessments at 1,2,4, and 8 weeks to assess sustainability of their response.
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|
The PSYRATS consists of 17 items on delusions and auditory hallucinations, with each item being rated from 0 (absent) to 4 (severe). The total score ranges from 0 to 68, with higher scores indicating more severe symptoms. |
| Up to 4/8 weeks. |
| Change in Scale for the Assessment of Positive Symptoms (SAPS) | The SAPS includes 34 items that focus on the positive symptoms on schizophrenia. Each item is rated from o to 5 (range=0-170). Higher scores indicate more severe symptoms. | Up to 4/8 weeks. |
| Change in Positive and Negative Syndrome Scale (PANSS) | The PANSS rates the presence and severity of positive and negative symptoms, as well as general psychopathology associated with schizophrenia. Each item is rated from 1 to 7 (range=30-210). Higher scores indicate more severe symptoms. | Up to 4/8 weeks. |
| Change in Cardiff Anomalous Perceptions Scale (CAPS) | The CAPS is a 32 item scale for measuring perceptual anomalies, that includes subscales for measuring distress, intrusiveness and frequency. A higher score indicates a higher number of perceptual anomalies, scores range from 0 (low) to 32 (high). | Up to 4/8 weeks. |
| Change in Clinical Global Impression Improvement (CGI-I) Scale | The CGI-I is a clinician-rated scale to quantify overall clinician impression of improvements in level of illness. The CGI-I is rated on a 7-point scale, to assess illness improvement. CGI-I scores range from 1 (very much improved) through to 7 (very much worse). | 2 weeks |
| Change in Clinical Global Impression Severity (CGI-S) Scale | The CGI-S is a clinician-rated scale to quantify overall clinician impression of illness severity. The CGI-S is rated on a 7-point scale, to assess illness severity. CGI-S scores range from 1 (normal, not ill) through to 7 (among the most severely ill patients). | 2 weeks |
| BG001 | Partial Responders Undergo rTMS of the Left Temporo-parietal Junction (TPJ) | Partial responders to protocol #8116 will receive a type of TMS called repetitive TMS (rTMS) wherein the magnetic pulses delivered will be close together in a rapid sequence. They will be administered 10 days (10 sessions) of MRI-guided 1 Hz rTMS delivered to the original left temporo-parietal junction (TPJ) target. The rTMS parameters that will be used are a frequency of 1 Hz (1 pulse per second) at an intensity of 90% of the motor threshold (MT). Therefore, the investigators will deliver 1200 continuous pulses per session/day which adds up to 12,000 pulses in total for the whole treatment. Repetitive Transcranial Magnetic Stimulation (rTMS): During the rTMS session, an electromagnetic coil is placed on the scalp of the subject's head. The electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the region of the brain involved in speech perception. |
| BG002 | Complete Responders Undergo Four Follow-up Clinical Assessments | Complete responders to protocol #8116 will be offered followup clinical assessments at 1, 2, 4, and 8 weeks to assess sustainability of their response. |
| BG003 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | As N=1 for each arm, the baseline charactertistics are not being disclosed to protect the confidentiality of the participants. | Count of Participants | Participants |
|
| Race (NIH/OMB) | As N=1 for each arm, the baseline charactertistics are not being disclosed to protect the confidentiality of the participants. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Partial Responders Undergo rTMS of the Left Temporo-parietal Junction (TPJ) | Partial responders to protocol #8116 will receive a type of TMS called repetitive TMS (rTMS) wherein the magnetic pulses delivered will be close together in a rapid sequence. They will be administered 10 days (10 sessions) of MRI-guided 1 Hz rTMS delivered to the original left temporo-parietal junction (TPJ) target. The rTMS parameters that will be used are a frequency of 1 Hz (1 pulse per second) at an intensity of 90% of the motor threshold (MT). Therefore, the investigators will deliver 1200 continuous pulses per session/day which adds up to 12,000 pulses in total for the whole treatment. Repetitive Transcranial Magnetic Stimulation (rTMS): During the rTMS session, an electromagnetic coil is placed on the scalp of the subject's head. The electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the region of the brain involved in speech perception. |
| OG002 | Complete Responders Undergo Four Follow-up Clinical Assessments | Complete responders to protocol #8116 will be offered followup clinical assessments at 1, 2, 4, and 8 weeks to assess sustainability of their response. |
|
| Primary | Total Number of Follow-up Clinical Assessments Completed | The total number of follow-up clinical assessments completed for complete responders. A clinical assessment refers to answering questions about psychiatric symptoms to assess the sustainability of the patient's improvement from the previous study. | Zero participants analyzed as n=1 for each arm. Results are not included here to protect the confidentiality of the participants. | Posted | 8 weeks |
|
|
| Primary | Total Number of Treatment Emergent Adverse Events | The total number of treatment emergent adverse events for non responders and partial responders. An emergent adverse event is defined as any rTMS risk induced incident in research such as headache and seizure. | Zero participants analyzed as n=1 for each arm. Results are not included here to protect the confidentiality of the participants. | Posted | 2 weeks. |
|
|
| Secondary | Change in Auditory Hallucination Rating Scale (AHRS) | The AHRS is an investigator-administered scale assessing multiple characteristics of auditory verbal hallucinations. The total score ranges from 2 to 41, with higher scores indicating more severe symptoms. | Zero participants analyzed as n=1 for each arm. Results are not included here to protect the confidentiality of the participants. | Posted | Up to 4/8 weeks. |
|
|
| Secondary | Change in Psychotic Symptom Rating Scale (PSYRATS) | The PSYRATS consists of 17 items on delusions and auditory hallucinations, with each item being rated from 0 (absent) to 4 (severe). The total score ranges from 0 to 68, with higher scores indicating more severe symptoms. | Zero participants analyzed as n=1 for each arm. Results are not included here to protect the confidentiality of the participants. | Posted | Up to 4/8 weeks. |
|
|
| Secondary | Change in Scale for the Assessment of Positive Symptoms (SAPS) | The SAPS includes 34 items that focus on the positive symptoms on schizophrenia. Each item is rated from o to 5 (range=0-170). Higher scores indicate more severe symptoms. | Zero participants analyzed as n=1 for each arm. Results are not included here to protect the confidentiality of the participants. | Posted | Up to 4/8 weeks. |
|
|
| Secondary | Change in Positive and Negative Syndrome Scale (PANSS) | The PANSS rates the presence and severity of positive and negative symptoms, as well as general psychopathology associated with schizophrenia. Each item is rated from 1 to 7 (range=30-210). Higher scores indicate more severe symptoms. | Zero participants analyzed as n=1 for each arm. Results are not included here to protect the confidentiality of the participants. | Posted | Up to 4/8 weeks. |
|
|
| Secondary | Change in Cardiff Anomalous Perceptions Scale (CAPS) | The CAPS is a 32 item scale for measuring perceptual anomalies, that includes subscales for measuring distress, intrusiveness and frequency. A higher score indicates a higher number of perceptual anomalies, scores range from 0 (low) to 32 (high). | Zero participants analyzed as n=1 for each arm. Results are not included here to protect the confidentiality of the participants. | Posted | Up to 4/8 weeks. |
|
|
| Secondary | Change in Clinical Global Impression Improvement (CGI-I) Scale | The CGI-I is a clinician-rated scale to quantify overall clinician impression of improvements in level of illness. The CGI-I is rated on a 7-point scale, to assess illness improvement. CGI-I scores range from 1 (very much improved) through to 7 (very much worse). | Zero participants analyzed as n=1 for each arm. Results are not included here to protect the confidentiality of the participants. | Posted | 2 weeks |
|
|
| Secondary | Change in Clinical Global Impression Severity (CGI-S) Scale | The CGI-S is a clinician-rated scale to quantify overall clinician impression of illness severity. The CGI-S is rated on a 7-point scale, to assess illness severity. CGI-S scores range from 1 (normal, not ill) through to 7 (among the most severely ill patients). | Zero participants analyzed as n=1 for each arm. Results are not included here to protect the confidentiality of the participants. | Posted | 2 weeks |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Partial Responders Undergo rTMS of the Left Temporo-parietal Junction (TPJ) | Partial responders to protocol #8116 will receive a type of TMS called repetitive TMS (rTMS) wherein the magnetic pulses delivered will be close together in a rapid sequence. They will be administered 10 days (10 sessions) of MRI-guided 1 Hz rTMS delivered to the original left temporo-parietal junction (TPJ) target. The rTMS parameters that will be used are a frequency of 1 Hz (1 pulse per second) at an intensity of 90% of the motor threshold (MT). Therefore, the investigators will deliver 1200 continuous pulses per session/day which adds up to 12,000 pulses in total for the whole treatment. Repetitive Transcranial Magnetic Stimulation (rTMS): During the rTMS session, an electromagnetic coil is placed on the scalp of the subject's head. The electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the region of the brain involved in speech perception. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Complete Responders Undergo Four Follow-up Clinical Assessments | Complete responders to protocol #8116 will be offered followup clinical assessments at 1, 2, 4, and 8 weeks to assess sustainability of their response. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|