RecruitingNot Applicable

Neuromodulation and Neurorehabilitation for mTBI

United States200 participantsStarted 2021-04-01

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is studying a combination of neuromodulation and neurorehabilitation for mild TBI — can you explain what those treatments actually involve day-to-day, and whether my current symptoms would make me a reasonable candidate to discuss with the research team?
2The trial is measuring improvement using something called the Mayo Portland Adaptability Inventory, which tracks how well people adapt after brain injury — what does that tell us about what the researchers are trying to change, and is that outcome relevant to my specific challenges?
3Since this trial has no assigned phase, it may be more exploratory in nature — what does that mean for how much we already know about the safety and effectiveness of these neuromodulation techniques in people with mild TBI and PTSD?
4This trial addresses both mild TBI and PTSD together — given that I may be dealing with symptoms of both, do you think a combined treatment approach like this makes sense for me right now, or would it be better to pursue standard treatments for one condition first?
5How demanding would participation in this trial likely be in terms of time, travel, or number of visits, and is that realistic given my current situation?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in the Mayo Portland Adaptability Inventory (MPAI)

Timeframe: baseline, 5 weeks, 10 weeks, 20 weeks

Trial details

NCT IDNCT03819608

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Catherine M Kestner

708-878-0578 ckestner@sralab.org

View on ClinicalTrials.gov More Mild Traumatic Brain Injury trials