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| ID | Type | Description | Link |
|---|---|---|---|
| UG3MH137656 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| The New Venture Fund / Foundation for OCD Research | UNKNOWN |
| The Wellcome Leap Fund | UNKNOWN |
| National Institute of Mental Health (NIMH) | NIH |
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Repetitive transcranial magnetic stimulation (rTMS) is a FDA-approved treatment for depression and Obsessive Compulsive Disorder (OCD). The goal of the study is to learn how to optimize the treatment to improve symptoms of depression and OCD. This research project will test a new accelerated 5-day accelerated rTMS protocol for treating symptoms of depression and OCD.
A second goal of this study is to identify biomarkers of depression and OCD in the brain using functional magnetic resonance imaging (fMRI). This approach will predict who will benefit from TMS, determine the optimal treatment target, and improve treatment outcomes. Subjects will receive a clinical assessment of symptoms and an fMRI brain scan before and after each treatment course to measure the effect of treatment on symptom severity and on fMRI measures of functional connectivity.
Participants will be randomized to receive rTMS targeting either the lateral prefrontal cortex (LPFC) or the dorsomedial prefrontal cortex (DMPFC). Participants will complete a 5-day course of rTMS delivered hourly for 10 hours per day. Participants who show a partial response to treatment but not a full response will then receive a second 5-day course. Treatment non-responders will be crossed over to receive rTMS targeting the opposite brain area.
The primary hypothesis is that accelerated rTMS treatment will yield rapid improvement in symptoms for patients with depression and OCD in just 5 days, and that response rates can be further improved by adding a second 5-day treatment course.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Depression - DMPFC target to (for non-responders) LPFC target | Experimental | Participants with treatment resistant depression will receive a 5-day course of rTMS delivered to the DMPFC. Participants may have the option to be crossed over to receive rTMS targeting the opposite brain area (LPFC), enabling us to test whether participants who do not respond well to one target might respond to stimulation of another target. The option to offer a second course of treatment will be based on clinical judgement and re-evaluation of the participant. |
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| Depression - LPFC target to (for non-responders) DMPFC target | Active Comparator | Participants with treatment resistant depression will receive a 5-day course of rTMS delivered to the LPFC. Participants may have the option to be crossed over to receive rTMS targeting the opposite brain area (DMPFC), enabling us to test whether participants who do not respond well to one target might respond to stimulation of another target. The option to offer a second course of treatment will be based on clinical judgement and re-evaluation of the participant. |
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| OCD - DMPFC target to (for non-responders) LPFC target | Experimental | Participants with OCD will receive a 5-day course of rTMS delivered to the DMPFC.Participants may have the option to be crossed over to receive rTMS targeting the opposite brain area (LPFC), enabling us to test whether participants who do not respond well to one target might respond to stimulation of another target. The option to offer a second course of treatment will be based on clinical judgement and re-evaluation of the participant. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MagVenture MagPro System with Brainsight neuronavigation device | Device | 10x daily sessions of 1200 pulses of theta-burst stimulation lasting approximately ten minutes. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Yale-Brown Obsessive Compulsive Scale (YBOCS) scores for participants with OCD | The YBOCS is a measure of obsessive compulsive symptoms is scored on a scale of 0 to 40, with 0 being no symptoms and 40 being extreme symptoms of OCD. | Baseline to Treatment End: Day 5, 10, 15, or 20 (depending on number of 5-day treatment courses administered) |
| Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores for participants with treatment resistant depression | The MADRS is a measure of depression symptoms and is scored on a scale of 0 to 60, with 0 being no depressive symptoms and 60 being severe depressive symptoms. | Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Quick Inventory of Depressive Symptomatology (QIDS) scores for participants with OCD | The QIDS is a self-report measure of depression symptoms and is scored on a scale of 0 to 27, with 0 being no depressive symptoms and 27 being severe depressive symptoms. | Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megan Johnson | Contact | 646-962-2900 | tmsinfo@med.cornell.edu | |
| Lindsay Victoria, PhD | Contact | liv3002@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Conor Liston, MD, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | Recruiting | New York | New York | 10065 | United States |
Individual data collected during the trial will be available after deidentification upon request to the PI. Data to be shared include deidentified clinical assessment scores and MRI images.
Deidentified data will be available any time following publication of outcomes from this study, with no specified end date.
Deidentified data will be shared with any researcher requesting access.
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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Subjects will be randomized to receive rTMS targeting the DMPFC or the LPFC. The treatment course will be 10 sessions per day hourly for 5 days. Participants may have the option to be crossed over to receive rTMS targeting the opposite brain area, enabling us to test whether participants who do not respond well to one target might respond to stimulation of another target. The option to offer a second course of treatment will be based on clinical judgement and re-evaluation of the participant.
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| OCD - LPFC target to (for non-responders) DMPFC target | Active Comparator | Participants with OCD will receive a 5-day course of rTMS delivered to the LPFC. Participants may have the option to be crossed over to receive rTMS targeting the opposite brain area (DMPFC), enabling us to test whether participants who do not respond well to one target might respond to stimulation of another target. The option to offer a second course of treatment will be based on clinical judgement and re-evaluation of the participant. |
|
| Percent Change in Beck Depression Inventory (BDI) scores for participants with OCD | The BDI is a self-report measure of depression symptoms and is scored on a scale of 0 to 63, with 0 being no depressive symptoms and 63 being severe depressive symptoms. | Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered) |
| Percent Change in Patient Health Questionnaire (PHQ-9) scores for participants with OCD | The PHQ-9 is a self-report measure of depression symptoms and is scored on a scale of 0 to 63, with 0 being no depressive symptoms and 63 being severe depressive symptoms. | Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered) |
| Percent Change in Patient Health Questionnaire-9 (PHQ-9) scores for participants with OCD | The PHQ-9 is a self-report measure of depression symptoms and is scored on a scale of 0 to 63, with 0 being no depressive symptoms and 27 being severe depressive symptoms. | Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered) |
| Percent Change in Beck Anxiety Inventory (BAI) scores for participants with OCD | The BAI is a self-report measure of anxiety symptoms and is scored on a scale of 0 to 63, with 0 being no anxiety symptoms and 63 being severe anxiety symptoms. | Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered) |
| Percent Change in General Anxiety Disorder (GAD-7) scores for participants with OCD | The BAI is a self-report measure of anxiety symptoms and is scored on a scale of 0 to 21, with 0 being no anxiety symptoms and 21 being severe anxiety symptoms. | Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered) |
| Percent Change in 17-item Hamilton Depression Rating Scale (HAM-D) scores for participants with treatment resistant depression | The HAM-D is a clinician-rated measure of depression symptoms and is scored on a scale of 0 to 52, with 0 being no anxiety symptoms and 21 being severe depression symptoms. | Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered) |
| Percent Change in Beck Depression Inventory (BDI) scores for participants with treatment resistant depression | The BDI is a self-report measure of depression symptoms and is scored on a scale of 0 to 63, with 0 being no depressive symptoms and 63 being severe depressive symptoms. | Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered) |
| Change in resting-state fMRI connectivity between the frontostriatal network and limbic network in participants with OCD | Change in resting state fMRI connectivity between the frontostriatal network and limbic network will be measured as a between-network correlational score of 0 to 1, with 0 low between-network connectivity and 1 being the highest possible between-network connectivity. | Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered) |
| Change in resting-state fMRI connectivity between the frontostriatal network and limbic network in participants with treatment resistant depression | Change in resting state fMRI connectivity between the frontostriatal network and limbic network will be measured as a between-network correlational score of 0 to 1, with 0 low between-network connectivity and 1 being the highest possible between-network connectivity. | Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered) |