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

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Repetitive Transcranial Magnetic Stimulation, Military Read More

Inclusion Criteria:

1. Age 18-64
2. Current or former US military service member
3. Eligible for care at DoD facilities
4. Able to provide written, informed consent in English

5. History of concussive TBI:

   1. >6 months prior to consent
   2. Documented previously in medical records and/or as confirmed by the TBI Screener
6. Must meet Criterion A of the DSM-5 criteria for Major Depressive Disorder as determined by a trained assessor
7. Baseline MADRS >10

Exclusion Criteria:

1. Elevated risk of seizures:

   1. Prior history of unprovoked seizures other than within 24 hours of concussive TBI
   2. Family history of seizures
   3. History of TBI resulting in penetrating trauma based on the TBI Screener
   4. Presence of intracranial tumor or intraparenchymal hemorrhage based on the structural MRI scan
   5. Heavy alcohol consumption within 48 hours, prior to any treatment session
   6. Receiving tricyclic antidepressants or neuroleptics at doses that lower seizure threshold

2. Contraindications to awake 3T MRI without contrast:

   1. Ferromagnetic implants or metallic shrapnel
   2. Severe claustrophobia
   3. Unable to lie awake, supine, stationary, with reasonable comfort in the scanner for approximately 45 minutes
   4. Markedly distorted functional brain anatomy such that rsfMRI targeting cannot be performed
3. History of severe or recent uncontrolled heart disease
4. Presence of a cardiac pacemaker or intracardiac lines
5. Implanted neurostimulators and medication pumps
6. Presence of rapidly progressive illnesses such as late stage cancer, neurodegenerative conditions, major organ failure, etc.
7. History of Bipolar Disorder, Schizophrenia Spectrum Disorders, or Moderate/Severe Substance Use Disorders, with the exception of nicotine use disorders
8. Increased risk of suicide as clinically evaluated
9. Current evidence of substance-induced mood disorder, active psychosis, and/or depression secondary to general medical illness (other than TBI)
10. Concomitant or previous history of receiving open-label TMS, other neurostimulatory treatment, or electroconvulsive therapy

11. 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

12. Unilateral or bilateral upper extremity amputation or other condition precluding motor threshold calibration
13. 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.)