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Neuromodulation and Neurorehabilitation for Mild Traumatic Brain Injury

This study is looking at how two treatments, real iTBS (Intermittent Theta Burst Stimulation, a type of brain stimulation) and real APT (Attention Processing Training, a computer program), might help people with attention problems after a mild traumatic brain injury (mTBI), with or without PTSD. Researchers want to see if combining these treatments improves attention and how they affect the brain. You could be eligible if you are 18-80 years old, at least 3 months past your mTBI, and have certain levels of mTBI or PTSD. The main way they will measure success is by looking at changes in your daily functioning using the Mayo Portland Adaptability Inventory (MPAI) over several months. The current status of this study is unclear.

Study design
This interventional study plans to enroll 200 participants. It compares real iTBS and real APT against placebo versions of both treatments.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your daily functioning will be measured at baseline, 5 weeks, 10 weeks, and 20 weeks after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03819608

Neuromodulation and Neurorehabilitation for mTBI

Recruiting
NAAges 18–80InterventionalTreatment
Northwestern University
~200 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:real iTBSreal APTplacebo APTplacebo iTBS

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in the Mayo Portland Adaptability Inventory (MPAI)
Measured over baseline, 5 weeks, 10 weeks, 20 weeks

Conditions

Mild Traumatic Brain Injury
Post Traumatic Stress Disorder

Explore related trials

ConcussionPost-Traumatic Stress Disorder

Where it's being run

2 sites across 2 states
Illinois1
Texas1

Study leadership

  • Theresa LB Pape, Dr.PH · PRINCIPAL_INVESTIGATOR · Northwestern University

Who to contact

Catherine M Kestner
[email protected]
708-878-0578
Email the study team

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Do you actually qualify for this trial?

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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

What this trial measures

  • Change in the Mayo Portland Adaptability Inventory (MPAI)baseline, 5 weeks, 10 weeks, 20 weeks

    Self-reported ability, adjustment and community participation. It is comprised of 30 items and three subscales: Ability Index, Adjustment Index and Participation Index. Items are scored on a 5-point Likert scale, with lower scores indicating higher levels of functioning.