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NCT03819608NARecruiting

Neuromodulation and Neurorehabilitation for mTBI

Northwestern University

Start Date

4/1/2021

Completion Date

12/1/2026

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 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 +/- PTSD.

Eligibility Criteria

Age Range: 18 years to 80 years

Inclusion Criteria: * 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 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, 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

Interventions

DEVICE

real iTBS

BEHAVIORAL

real APT

BEHAVIORAL

placebo APT

DEVICE

placebo iTBS

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Conditions

Mild Traumatic Brain InjuryPost Traumatic Stress Disorder

Locations

Northwestern University

Chicago, Illinois 60141

United States

Moody Neurorehabilitation Institute

Houston, Texas 77058

United States