NCT03819608 Neuromodulation and Neurorehabilitation for mTBI
| NCT ID | NCT03819608 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwestern University |
| Condition | Mild Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2021-04-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2021-04-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Theresa LB Pape, Dr.PH
PRINCIPAL INVESTIGATOR
Northwestern University
Frequently Asked Questions
Who can join the NCT03819608 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Mild Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03819608 currently recruiting?
Yes, NCT03819608 is actively recruiting participants. Contact the research team at ckestner@sralab.org for enrollment information.
Where is the NCT03819608 trial being conducted?
This trial is being conducted at Chicago, United States, Houston, United States.
Who is sponsoring the NCT03819608 clinical trial?
NCT03819608 is sponsored by Northwestern University. The principal investigator is Theresa LB Pape, Dr.PH at Northwestern University. The trial plans to enroll 200 participants.