rTMS for Military TBI-related Depression

This is an interventional treatment trial for Depressive Symptoms Read More

Inclusion Criteria:

• Age 18-50 at the time of consent
• Current or former US military service member eligible for care at a military treatment facility
• Able to provide written, informed consent in English

• History of concussion (mild TBI), > 6 months, but < 20 years prior to consent, as defined by:

  1. positive loss of consciousness of <30 minutes as confirmed by TBI screener and/or medical records and/or;
  2. positive alteration of consciousness of <24 hours as confirmed by TBI screener and/or medical records and/or;
  3. positive post-traumatic amnesia of 0 to 1 day as confirmed by TBI screener and/or medical records
• Baseline MADRS >13

• Maintained a steady psychotropic medication regimen for six weeks and a steady behavioral therapy regimen for twelve weeks prior to enrollment in the study

  1. participants will be urged to maintain their medication and behavioral therapy regimen throughout the study, unless otherwise recommended by their personal physician
  2. changes in medication and/or behavioral therapy regimens will be reviewed and assessed with the study team before participants can continue their enrollment

• Female participants with child-bearing potential must agree to use an effective method of birth control during the course of the study. For the purposes of this study, acceptable forms of birth control include:

  1. abstinence
  2. Surgical sterilization (hysterectomy, tubal ligation, vasectomy for male partners)
  3. condoms
  4. diaphragm
  5. birth control pill or patch
  6. intrauterine device (IUD)
• Under the care of a primary care and/or behavioral health provider

Exclusion Criteria:

• Elevated risk of seizures at the time of rTMS including any of the following:

  1. History of unprovoked seizures or any seizure within 24 hours of sustaining a concussion(s) or other head injury regardless of whether it was determined to have been related to concussion
  2. Family history of two or more unprovoked seizures in a first degree relative (parent, sibling, or child)
  3. History of moderate or severe TBI based on TBI screener and/or medical records
  4. History of penetrating TBI based on TBI screener and/or medical records
  5. Intracranial lesion (such as intracranial tumor or intraparenchymal hemorrhage) that, in the opinion of the investigator, would be unsafe with MRI or TMS, or that would produce an artifact that would compromise the integrity of data
  6. Currently taking medication or other substances (such as tricyclic antidepressants or neuroleptics) that, in the opinion of the investigator, lowers the seizure threshold
• Contra-indications to awake 3T MRI without contrast at the time of Baseline MRI
• History of severe or recent uncontrolled heart disease
• Presence of a cardiac pacemaker or intracardiac lines
• Any implant, prosthesis, or other permanent alteration of the body (i.e., implanted neurostimulators and medication pumps) that, in the opinion of the investigator, would be unsafe with MRI or TMS, or that would produce an artifact that would compromise the integrity of data
• Presence of rapidly progressive illnesses such as late-stage cancer, neurodegenerative conditions, major organ failure, etc.
• History of bipolar disorder or schizophrenia spectrum disorders
• Current evidence of substance-induced mood disorder, active psychosis, or depression, secondary to general medical illness other than TBI
• Concomitant or lifetime history of receiving open-label TMS
• Concomitant or recent history (within 6 months prior to enrollment) of receiving other neurostimulatory treatment, including but not limited to transcranial direct current (tDCS), transcranial alternating current (tACS), alpha stim, or electroconvulsive therapy
• Unilateral or bilateral upper extremity amputation or other condition precluding motor threshold calibration
• Suicide attempt within six months prior to enrollment
• Unable to complete timeline of the study
• Severe claustrophobia interfering with medication/sedation-free 3T closed-bore MRI
• Any considerations that, in the opinion of the investigator, may adversely affect participant safety, participation, or the scientific validity of the data being collected (e.g., severe or controlled uncontrolled substance abuse, inability to remain on a steady neurotropic medication and/or behavioral therapy regimen over the course of the randomization phase of the study, planned hospitalization half-way through the initial randomization period, limited life expectancy, prisoners, or others who have legally restricted freedom of movement and participants, etc.)