Brain Connectivity in Depression
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03276793 |
Recruitment Status :
Recruiting
First Posted : September 8, 2017
Last Update Posted : May 18, 2022
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Condition or disease | Intervention/treatment | Phase |
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Depression | Other: MRI scan Behavioral: Behavioral testing | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Using Human Brain Connectivity to Identify the Causal Neuroanatomical Substrate of Depression Symptoms |
Actual Study Start Date : | April 3, 2018 |
Estimated Primary Completion Date : | October 31, 2022 |
Estimated Study Completion Date : | October 31, 2022 |

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.
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Other: MRI scan
Patients will undergo an MRI scan Behavioral: Behavioral testing Patients will complete a series of cognitive tasks |
- Prediction of repetitive Transcranial Magnetic Stimulation (rTMS) clinical response [ Time Frame: 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

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female
- Aged 18-70.
- 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:
- 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)
- 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.
- Patients who are pregnant or lactating (by menstrual history)
- 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:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03276793
Contact: Stephan Palm, BS | 617-732-6658 | spalm1@bwh.harvard.edu | |
Contact: Christopher Lin, BS | clin@bwh.harvard.edu |
United States, Massachusetts | |
Brigham and Women's Hospital | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Michael D Fox, MD, PhD 617-732-7432 mdfox@bwh.harvard.edu | |
Sub-Investigator: Sandrine Jabbour, BS | |
Principal Investigator: Michael D Fox, MD, PhD | |
Sub-Investigator: Joseph J Taylor, MD, PhD | |
Sub-Investigator: Claudia Becker, BS | |
Sub-Investigator: Jing Li, BS | |
Sub-Investigator: Christopher Lin, BS | |
Beth Israel Deaconess Medical Center | Active, not recruiting |
Boston, Massachusetts, United States, 02215 | |
United States, Rhode Island | |
Butler Hospital | Recruiting |
Providence, Rhode Island, United States, 02906 | |
Contact: Linda Carpenter, MD 401-455-6632 linda_carpenter_md@brown.edu | |
Sub-Investigator: Eric Tirrell, BS |
Responsible Party: | Michael D. Fox, M.D.,Ph.D., Associate Professor, Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT03276793 |
Other Study ID Numbers: |
2021P000335 |
First Posted: | September 8, 2017 Key Record Dates |
Last Update Posted: | May 18, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |