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Brain Connectivity in Depression

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. Identifier: NCT03276793
Recruitment Status : Recruiting
First Posted : September 8, 2017
Last Update Posted : July 1, 2020
Information provided by (Responsible Party):
Michael Fox, Beth Israel Deaconess Medical Center

Brief Summary:
This study will include 60 subjects with medication-refractory depression undergoing transcranial magnetic stimulation (TMS) to the left dorsal lateral prefrontal cortex (DLPFC). In order to obtain good quality data and account for attrition, 80 subjects will be recruited. Subjects will be recruited from the Clinical Program of FDA approved TMS at the Berenson-Allen Center and the Butler TMS Clinic (40 per site). Subjects will undergo 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 will last 45-60 minutes and consist of 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 Hamilton Depression Rating Scale (HDRS) and Beck Depression Inventory (BDI) will also be 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 objective measures of symptom improvement.

Condition or disease Intervention/treatment Phase
Depression Other: MRI scan Behavioral: Behavioral testing Not Applicable

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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

Resource links provided by the National Library of Medicine

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.
Other: MRI scan
Patients will undergo an MRI scan

Behavioral: Behavioral testing
Patients will complete a series of cognitive tasks

Primary Outcome Measures :
  1. Prediction of 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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:

  1. Male or female
  2. Aged 18-70.
  3. Have previously received or will receive TMS to the left dorsal-lateral prefrontal cortex as part of the clinical treatment program at the Berenson-Allen Center for Non-invasive Brain Stimulation at Beth Israel Deaconess Medical Center, or at Butler Hospital for treatment of medication resistant depression

Exclusion Criteria:

  1. Any current or past history of a major psychiatric illness other than depression (e.g. bipolar affective disorder, schizophrenia, obsessive compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder)
  2. 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.
  3. Patients who are pregnant or lactating (by menstrual history)
  4. Current abuse of an illicit substance (e.g. marijuana, cocaine, heroin, hallucinogens, psychostimulants)
  5. 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.
  6. Subjects that cannot adhere to the experimental protocol for any reason.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03276793

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Contact: Molly Schineller, BS 617-667-1571

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United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Michael Fox, MD, PhD    617-667-0220   
Principal Investigator: Michael Fox, MD, PhD         
Sub-Investigator: Daniel Press, MD         
Sub-Investigator: Adam Stern, MD         
Sub-Investigator: Ann Connor, RN         
Sub-Investigator: Carrie Hinchman, BS         
Sub-Investigator: Joanna Macone, RN         
Sub-Investigator: Molly Schineller, BS         
Sub-Investigator: Tina Arani, BS         
Sub-Investigator: Shan Siddiqi, MD         
Sub-Investigator: Joseph Taylor, MD, PhD         
Sub-Investigator: Shobhik Chakraborty, BS         
Sub-Investigator: Christopher Lin, BS         
United States, Rhode Island
Butler Hospital Not yet recruiting
Providence, Rhode Island, United States, 02906
Contact: Linda Carpenter, MD    401-455-6632   
Sub-Investigator: Eric Tirrell, BS         
Sub-Investigator: Gina Sensale, BS         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
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Responsible Party: Michael Fox, Assistant Professor of Neurology, Beth Israel Deaconess Medical Center Identifier: NCT03276793    
Other Study ID Numbers: 2017P000514
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders