Status:
RECRUITING
Neuromodulation and Neurorehabilitation for mTBI
Lead Sponsor:
Northwestern University
Conditions:
Mild Traumatic Brain Injury
Post Traumatic Stress Disorder
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 t...
Eligibility Criteria
Inclusion
- At least 18 years of age and no older than 80 years of age
- 3 months post exposure to mTBI event
- Have a history of mTBI with PTSD OR mTBI without PTSD as defined by formalized measures to classify mTBI based on the Symptom Attribution and Classification Algorithm (SACA) and the PTSD Module L of the SCID
- Endorse at least moderate severity on at least one of the four cognitive complaints in the Neurobehavioral Symptom Inventory
Exclusion
- 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, 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
- Prescribed dosage of mental health medications have been altered within the month preceding study screening. Any participant whose mental health medication(s) has/have changed, within 30 days of study screening. The following are considered a medication change: the addition of or discontinuation of medication, a change in the dose or dosage (daily amount) of medication.
- Taking prescribed CNS stimulants and choosing to not stop these medications during study participation
- 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.
- 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 ≥ 6 symptoms on the SCID-5
- Baseline systolic BP greater or equal to 170
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03819608
Start Date
April 1 2021
End Date
December 1 2025
Last Update
April 2 2025
Active Locations (2)
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1
Northwestern University
Chicago, Illinois, United States, 60141
2
Moody Neurorehabilitation Institute
Houston, Texas, United States, 77058