Status:
RECRUITING
Brain Connectivity in Depression
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Butler Hospital
Massachusetts General Hospital
Conditions:
Depression
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study originally included 140 subjects with medication-refractory depression undergoing 10 Hz transcranial magnetic stimulation (10Hz-TMS) to the left dorsal lateral prefrontal cortex (DLPFC), wi...
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 was transferred to the Mass Ge...
Eligibility Criteria
Inclusion
- Male or female
- Aged 18 or older
- 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
- 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
- Lack of response to an adequate trial of electroconvulsive therapy (ECT) or any ECT in the preceding 3 months
- Prior adequate trial of TMS treatment in the last 12 months
- Positive MRI screen that would preclude the subject from undergoing magnetic resonance imaging. These include, but are not limited to any of the following:
- Known metal in the head (such as a surgical aneurysm clip), or a history of prior neurosurgical procedures
- 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
- Subjects who have or might have bullet fragments or other metal fragments (veterans or workers exposed to metal in their work environment)
- Subjects with metallic paint (e.g. color contact lenses, tattoos, metallic eyeliner)
- Subjects expressing significant anxiety or claustrophobia about being in the magnet.
- Subjects that cannot adhere to the experimental protocol for any reason.
Key Trial Info
Start Date :
April 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT03276793
Start Date
April 3 2018
End Date
October 31 2027
Last Update
April 21 2025
Active Locations (4)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02129
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
4
Butler Hospital
Providence, Rhode Island, United States, 02906