Brain Connectivity in Depression
Study Details
Study Description
Brief Summary
This study will include 60 subjects with medication-refractory depression undergoing transcranial magnetic stimulation (TMS) to the left dorsal lateral prefrontal cortex (DLPFC). In order to obtain good quality data and account for attrition, 100 subjects will be recruited. Subjects will be recruited from the Clinical Program of FDA approved TMS at the Center for Brain Circuit Therapeutics TMS Clinic and the Butler TMS Clinic. Subjects will undergo an hour-long MRI scanning session, an optional DNA-sample collection, up to three 20 minute neuronavigation sessions for marking the site of TMS stimulation, questionnaires, and a behavioral testing battery before and after their TMS treatment course. The task battery will last 45-60 minutes and consist of the Emotion Conflict Resolution (ECR) task, Multi-Source Interference Task (MSIT), War Game (Gambling) task, and Associative Learning with Reversal task. Subjects' scores on the Quick Inventory of Depressive Symptomatology (QIDS) and Beck Depression Inventory (BDI) will also be assessed before and after the TMS course. MRI data will be utilized to identify brain regions whose connectivity to the stimulation site co-varies with the aforementioned objective measures of symptom improvement.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This study was originally approved by the Beth Israel Deaconess Medical Center (BIDMC) Institutional Review Board (IRB) with Butler Hospital as a relying site. The study is now transferred to the Mass General Brigham (MGB) IRB so that Dr. Fox, as the lead PI, can continue to provide oversight as his primary appointment is now at Brigham and Women's Hospital (BWH). Butler Hospital is now relying on the MGB IRB for regulatory oversight and will also be conducting all study procedures, while BIDMC will not become a relying site and will stop enrolling subjects. A Data Usage Agreement is established between BIDMC and BWH, and all previously collected Data will be de-identified and sent to BWH. The protocol at BIDMC will remain active but not enrolling until all the de-identified data has been sent to BWH.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MRI and behavioral assessment Subjects will undergo an hour-long MRI scanning session, a marking for the site of planned clinical TMS stimulation and a behavioral testing battery before and after their TMS treatment course. |
Other: MRI scan
Patients will undergo an MRI scan
Behavioral: Behavioral testing
Patients will complete a series of cognitive tasks
|
Outcome Measures
Primary Outcome Measures
- Prediction of repetitive Transcranial Magnetic Stimulation (rTMS) clinical response [1 year after study completion]
Connectivity between each patient's stimulation site and the subgenual cingulate will be used to predict clinical response to rTMS
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female
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Aged 18-70.
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Have previously received or will receive TMS to the left dorsal-lateral prefrontal cortex as part of the clinical treatment program at the Center for Brain Circuit Therapeutics at Brigham and Women's Hospital, or at Butler Hospital for treatment of medication resistant depression
Exclusion Criteria:
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Any current or past history of a major psychiatric illness other than depression and anxiety (e.g. bipolar affective disorder, schizophrenia, obsessive compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder)
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Any significant current neurological illness (e.g. a history of seizures or unexplained loss of consciousness, a family history of epilepsy, signs of increased intracranial pressure, previously abnormal MRI scans, parkinsonism or dementia). Of note, most of these are also contraindications to receiving TMS and these patients would not be enrolled in the clinical treatment program.
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Patients who are pregnant or lactating (by menstrual history)
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Current abuse of an illicit substance (e.g. marijuana, cocaine, heroin, hallucinogens, psychostimulants)
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Positive MRI screen that would preclude the subject from undergoing magnetic resonance imaging. These include, but are not limited to any of the following:
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Known metal in the head (such as a surgical aneurysm clip), or a history of prior neurosurgical procedures
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Ferromagnetic bioimplants activated by any electronic, mechanical or magnetic means such as: cochlear implants, pacemakers, medication pumps, vagal stimulators, deep brain stimulators, neurostimulators, biostimulators, or ventriculo-peritoneal shunts
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Subjects who have or might have bullet fragments or other metal fragments (veterans or workers exposed to metal in their work environment)
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Subjects with metallic paint (e.g. color contact lenses, tattoos, metallic eyeliner)
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Subjects expressing significant anxiety or claustrophobia about being in the magnet.
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Subjects that cannot adhere to the experimental protocol for any reason.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
| 2 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 3 | Butler Hospital | Providence | Rhode Island | United States | 02906 |
Sponsors and Collaborators
- Brigham and Women's Hospital
- Butler Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021P000335