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Neuromodulation and Neurorehabilitation for mTBI Plus PTSD

Neuromodulation and Neurorehabilitation for mTBI Plus PTSD

Recruiting
18-60 years
All
Phase N/A

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Overview

This study will determine (i) the magnitude of immediate and sustained effects of a current clinical standard interactive computer attention processing training (APT) when combined with intermittent theta burst stimulation (iTBS), a type of repetitive transcranial magnetic stimulation and (ii) determine how APT + iTBS changes the neurocognitive system of attention in individuals with persistent attention deficits related to mTBI and PTSD.

Eligibility

Inclusion Criteria:

  • At least 18 years of age and no older than 60 years of age
  • 3 months to 10 years post exposure to mTBI event
  • Have co-occurring mTBI and PTSD as defined by the Symptom Attribution and Classification Algorithm (SACA) and the Clinically Administered PTSD Scale for DSM-V (CAPS-5)

Exclusion Criteria:

  • Participating in another research study
  • Non-fluent in English (speaking and reading)
  • History of epilepsy pre-injury
  • Receiving antiepileptic treatment for documented active seizures in the past 6 months
  • Taking medications that lower seizure threshold including antipsychotics, buproprion, trazodone and tramadol
  • History of surgery on blood vessels in brain and/or valves of the heart
  • History of brain hemorrhage, neurovascular conditions and neurodegenerative disorders
  • History or current diagnosis of psychotic spectrum disorders (i.e. bipolar, schizophrenia)
  • Significant heart disease as determined by physician review of medical chart
  • Pregnant at time of enrollment or any time during study participation
  • MRI or TMS/iTBS contraindications such as claustrophobia, metal in eyes/face or brain
  • Cardiac pacemakers/defibrillators, cochlear implants, nerve stimulators, intracranial metal clips
  • Diagnosis of moderate or severe TBI (loss of consciousness > 30 minutes, alteration of consciousness > 24 hours, post traumatic amnesia or neuropsychological testing results
  • Mental health medications have been altered within the month preceding study screening
  • Taking prescribed CNS stimulants and choosing to not stop these medications during study participation
  • Testing positive for opiates and do not have a prescription for opiates. If on prescription opiates and taking more than the equivalent of 200 mg of morphine per day.
  • Taking tricyclic antidepressants
  • Questionably valid test performance as indicated by a score of ≤ 85% on the Immediate Recognition, Delayed Recognition or Consistency Scales of the Medical Symptom Validity Test (MSVT) and clinical determination of questionable performance validity by a neuropsychologist on the research team
  • Actively suicidal as evidenced by plan to harm or recent attempt communicated on the Structured Clinical Interview for DSM-V (SCID-5).
  • Increased Intracranial Pressure (ICP) as evidenced through a funduscopic evaluation or on the baseline MRI scan.
  • Moderate or severe cannabis use disorder defined by ≥ 4 symptoms on the SCID-5
  • Severe alcohol use disorder defined by ≥ 4 symptoms on the SCID-5

Study details
    Mild Traumatic Brain Injury
    Post Traumatic Stress Disorder

NCT03819608

Theresa Pape

26 January 2024

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