Exploring brain connectivity in patients with depression
Using Human Brain Connectivity to Identify the Causal Neuroanatomical Substrate of Depression Symptoms
This study is testing if a special brain treatment called TMS can improve brain function and help people with depression who haven't found relief from medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 4 sites (Boston, Massachusetts and 3 other locations) |
| Trial ID | NCT03276793 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of 10 Hz transcranial magnetic stimulation (TMS) on brain connectivity in individuals with medication-refractory depression. Participants undergo MRI scans, behavioral testing, and TMS treatment to assess changes in their depressive symptoms and brain function. The study aims to collect data from 140 subjects, with a focus on understanding the neural mechanisms underlying depression and the efficacy of TMS as a treatment. The research is conducted at multiple prestigious hospitals in Boston, ensuring a robust data collection process.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with medication-refractory depression who are receiving TMS treatment.
Not a fit: Patients with significant neurological disorders or those who have not responded to electroconvulsive therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from medication-resistant depression.
How similar studies have performed: Other studies have shown promise in using TMS for depression, indicating that this approach has potential based on previous findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female 2. Aged 18 or older 3. Have previously received or will once daily TMS treatment to the left dorsolateral prefrontal cortex at the Center for Brain Circuit Therapeutics at Brigham and Women's Hospital, or at Massachusetts General Hospital for treatment of medication resistant depression Exclusion Criteria: 1. Presence of a significant neurologic disorder (i.e. Parkinson's Disease, stroke, Alzheimer's Disease, tumor, multiple sclerosis, epilepsy) or other significant active medical problems which may impact treatment or safety. Of note, many of these are also contraindications to receiving TMS and these patients would not be enrolled in the clinical treatment program. Because these diagnoses, their significance, and the extent to which they are an active issue can be subjective, each of these exclusions (1-3) will be reviewed by the PI or study physician 2. Lack of response to an adequate trial of electroconvulsive therapy (ECT) or any ECT in the preceding 3 months 3. Prior adequate trial of TMS treatment in the last 12 months 4. Positive MRI screen that would preclude the subject from undergoing magnetic resonance imaging. These include, but are not limited to any of the following: 1. Known metal in the head (such as a surgical aneurysm clip), or a history of prior neurosurgical procedures 2. 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 3. Subjects who have or might have bullet fragments or other metal fragments (veterans or workers exposed to metal in their work environment) 4. Subjects with metallic paint (e.g. color contact lenses, tattoos, metallic eyeliner) 5. Subjects expressing significant anxiety or claustrophobia about being in the magnet. 5. Subjects that cannot adhere to the experimental protocol for any reason.
Where this trial is running
Boston, Massachusetts and 3 other locations
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Completed)
- Butler Hospital — Providence, Rhode Island, United States (Active_not_recruiting)
Study contacts
- Study coordinator: David Lawson, BA
- Email: bwh_fdctrial@mgb.org
- Phone: 617-732-6658
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.