Neuromodulation and Neurorehabilitation for mTBI Plus PTSD



Status:Recruiting
Conditions:Neurology, Neurology, Psychiatric, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 60
Updated:3/15/2019
Start Date:March 2019
End Date:March 2024
Contact:Catherine M Kestner
Email:Catherine.Kestner@va.gov
Phone:708-878-0578

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Neuromodulation and Neurorehabilitation for Treatment of Functional Deficits After mTBI and PTSD

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.


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
We found this trial at
2
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Hines, Illinois 60141
Phone: 708-202-4953
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303 East Superior Street
Chicago, Illinois 60611
Phone: 708-2028387
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Chicago, IL
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