Neuromodulation and Neurorehabilitation for mTBI

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Mild Traumatic Brain Injury, Post Traumatic Stress Disorder

In brief

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.

Key facts

Study ID

NCT03819608

Run by

Northwestern University

People needed

200

Starts

2021-04-01

Expected to finish

2026-12-01

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Northwestern University — Chicago, Illinois, United States (enrolling)
• Moody Neurorehabilitation Institute — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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