Recruiting

Observational Study

Sponsor:

Brigham and Women's Hospital

Code:

NCT03276793

Conditions

Depression

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MRI scan

Behavioral testing

Study Details

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), with the goal of having 60 completers with good quality data. Subjects were recruited from the TMS clinics at Beth Israel Deaconess Medical Center, Brigham \& Women's Hospital, and Butler Hospital. Subjects underwent 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 included 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) were assessed before and after the TMS course. MRI data was utilized to identify brain regions whose connectivity to the stimulation site co-varies with the aforementioned measures of symptom improvement. This was the only study group until August 30, 2022, and the primary outcome was analyzed for the 10Hz-TMS group.

Due to changes in clinical standard of care from 10Hz-TMS to a newer version of TMS termed intermittent theta burst (iTBS), in September 2022 a second group was added to include patients receiving this new form of TMS. This second group included another 100 patients with medication-refractory depression undergoing iTBS to the left dorsal lateral prefrontal cortex (DLPFC), with the intent to have 80 completers. Massachusetts General Hospital was added as a data collection site in lieu of Butler Hospital. Subjects will undergo an hour-long MRI scanning session, 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 included the Emotion Conflict Resolution (ECR) task, Multi-Source Interference Task (MSIT), Penn Emotion Recognition Test, the Suicide/Death Implicit Association Test, and Associative Learning with Reversal task. Subjects' scores on the Beck Depression Inventory (BDI) were 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 measures of symptom improvement.

Due to a higher dropout rate than anticipated, in March of 2025 an amendment was added to include an additional 20 subjects in the second group's enrollment goal to increase the likelihood of achieving 80 completers.

Conditions

Depression

Study ID

NCT03276793

Start date

Apr 3, 2018

Status verified date

Apr, 2025

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

260 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: MRI and behavioral assessment for patients receiving TMS

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.

Interventions

MRI scan

Patients will undergo an MRI scan

Behavioral testing

Patients will complete a series of cognitive tasks

Primary outcome measure

  • Prediction of repetitive Transcranial Magnetic Stimulation (rTMS) clinical response [ Time Frame: 1 year after study completion ]
  • Prediction of intermittent theta burst stimulation (iTBS) clinical response [ Time Frame: 1 year after study completion ]

Central Contacts and Locations

Central contacts

David Lawson, BA

617-732-6658bwh_fdctrial@mgb.org

Emma Jones, BS

bwh_fdctrial@mgb.org

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Michael D Fox, MD, PhD

617-732-7432bwh_fdctrial@mgb.org

Principal Investigator:

Michael D Fox, MD, PhD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02129

Contacts

Tracy A Barbour, MD

617-726-5340TBARBOUR@PARTNERS.ORG

Luke Janak, BS

Ljanak@mgh.harvard.edu

Principal Investigator:

Tracy A Barbour, MD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Apr 21, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-04-21.