Brain zaps and computer games: new hope for foggy minds after injury?
NCT ID NCT03819608
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing whether a non-invasive brain stimulation technique called iTBS, combined with computer-based attention training, can improve focus and daily functioning in people with persistent attention problems after a mild traumatic brain injury (mTBI), with or without PTSD. Researchers will enroll 200 adults aged 18-80 who are at least 3 months past their injury. The goal is to measure changes in real-world abilities and PTSD symptoms, not to cure the conditions.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2021
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Moody Neurorehabilitation Institute
RECRUITINGHouston, Texas, 77058, United States
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Northwestern University
RECRUITINGChicago, Illinois, 60141, United States
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