Weill Cornell Medicine
New York, 10065, United States
Location status: Recruiting
NCT Number: NCT04982757
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
New York, 10065, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
10x daily sessions of 1200 pulses of theta-burst stimulation lasting approximately ten minutes.
Time frame: Baseline to Treatment End: Day 5, 10, 15, or 20 (depending on number of 5-day treatment courses administered)
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.
Time frame: Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered)
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.
Time frame: Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered)
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.
Time frame: Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered)
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.
Time frame: Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered)
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.
Time frame: Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered)
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.
Time frame: Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered)
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.
Time frame: Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered)
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.
Time frame: Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered)
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.
Time frame: Baseline to Treatment End: Day 5 or 10 (depending on number of 5-day treatment courses administered)
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.
Time frame: 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 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.
Time frame: 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 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.
Contact information is provided by the study sponsor or research team.
Lindsay Victoria, PhD
CONTACT
Megan Johnson
CONTACT
Weill Medical College of Cornell University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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