NCT03819608 · Northwestern University
Neuromodulation and Neurorehabilitation for mTBI
What this study is about
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.
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Chicago, Illinois
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 8, 2026 · Source of record for eligibility and locations