fMRI-neuronavigated rTMS Treatment for Symptoms of Depression Associated With Concussive TBI in the Military Population

Stopped early · Not applicable · Has a placebo group

Conditions studied: Traumatic Brain Injury, Concussion, Mild, Depressive Symptoms

In brief

This study aims to investigate the efficacy and tolerability of fMRI-targeted repetitive transcranial magnetic stimulation (rTMS) in the treatment of depressive symptoms in service members with a history of concussive traumatic brain injury (TBI). Up to ninety participants will be randomized to active or sham treatment. Participants randomized into the active group will receive 20 sessions of left-sided dorsolateral prefrontal cortex (DLFPC) high-frequency rTMS, followed by right-sided DLFPC low-frequency rTMS. The DLPFC treatment area will be identified by using individual subject-level resting state network estimation (Hacker et al., 2013). Participants randomized into the sham treatment group will receive 20 sham treatments designed to have similar sound and tactile sensation, without producing active treatment. Participants will also be asked to complete regular follow-up evaluations for up to a total of six follow-up sessions. Those who do not respond to the treatment will have the option to receive active treatment through this study regardless of group assignment to active or sham.

Key facts

Study ID

NCT03523507

Run by

Henry M. Jackson Foundation for the Advancement of Military Medicine

People needed

10

Starts

2019-07-01

Expected to finish

2020-10-27

Last updated by the study team

2020-11-03

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-64
• Current or former US military service member
• Eligible for care at DoD facilities
• Able to provide written, informed consent in English
• History of concussive TBI:
• >6 months prior to consent
• Documented previously in medical records and/or as confirmed by the TBI Screener
• Must meet Criterion A of the DSM-5 criteria for Major Depressive Disorder as determined by a trained assessor
• Baseline MADRS >10

You may not qualify if…

• Elevated risk of seizures:
• Prior history of unprovoked seizures other than within 24 hours of concussive TBI
• Family history of seizures
• History of TBI resulting in penetrating trauma based on the TBI Screener
• Presence of intracranial tumor or intraparenchymal hemorrhage based on the structural MRI scan
• Heavy alcohol consumption within 48 hours, prior to any treatment session
• Receiving tricyclic antidepressants or neuroleptics at doses that lower seizure threshold
• Contraindications to awake 3T MRI without contrast:
• Ferromagnetic implants or metallic shrapnel
• Severe claustrophobia
• Unable to lie awake, supine, stationary, with reasonable comfort in the scanner for approximately 45 minutes
• Markedly distorted functional brain anatomy such that rsfMRI targeting cannot be performed
• History of severe or recent uncontrolled heart disease
• Presence of a cardiac pacemaker or intracardiac lines
• Implanted neurostimulators and medication pumps
• Presence of rapidly progressive illnesses such as late stage cancer, neurodegenerative conditions, major organ failure, etc.
• History of Bipolar Disorder, Schizophrenia Spectrum Disorders, or Moderate/Severe Substance Use Disorders, with the exception of nicotine use disorders
• Increased risk of suicide as clinically evaluated
• Current evidence of substance-induced mood disorder, active psychosis, and/or depression secondary to general medical illness (other than TBI)
• Concomitant or previous history of receiving open-label TMS, other neurostimulatory treatment, or electroconvulsive therapy
• Pregnancy
• a. Female participants of childbearing potential must agree to use an effective method of birth control during the course of the study, or to remain abstinent from sex, to ensure they do not become pregnant during the course of the study
• Unilateral or bilateral upper extremity amputation or other condition precluding motor threshold calibration
• Any considerations that, in the opinion of the investigator, may adversely affect patient safety, participation, or the scientific validity of the data being collected (e.g., planned hospitalization halfway through the initial treatment period, limited life expectancy, etc.)

Where it is running

• Walter Reed National Military Medical Center — Bethesda, Maryland, United States
• Fort Belvoir Community Hospital — Fort Belvoir, Virginia, United States

Full record on ClinicalTrials.gov

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