Exploring brain connectivity in patients with depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.