Combining brain stimulation with cognitive training for mild traumatic brain injury
Neuromodulation and Neurorehabilitation for Treatment of Functional Deficits After mTBI and PTSD
NA · Northwestern University · NCT03819608
This study is testing whether combining brain stimulation with attention training can help people with mild traumatic brain injury and PTSD improve their focus and attention.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Northwestern University (other) |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT03819608 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of combining interactive computer attention processing training (APT) with intermittent theta burst stimulation (iTBS) on individuals with mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD). It aims to assess both the immediate and long-term impacts of this combined approach on attention deficits associated with mTBI. Participants will receive either the real treatment or placebo versions of APT and iTBS to evaluate changes in their neurocognitive systems. The study will also utilize neuroimaging to understand the underlying mechanisms of any observed effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who are at least three months post-mTBI and experience persistent attention deficits, with or without PTSD.
Not a fit: Patients currently participating in other research studies or those with certain neurological conditions or severe psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve attention and cognitive function in patients suffering from mTBI and PTSD.
How similar studies have performed: Other studies have shown promise in using neuromodulation techniques for cognitive rehabilitation, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois and 1 other locations
- Northwestern University — Chicago, Illinois, United States (RECRUITING)
- Moody Neurorehabilitation Institute — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Theresa LB Pape, Dr.PH — Northwestern University
- Study coordinator: Catherine M Kestner
- Email: ckestner@sralab.org
- Phone: 708-878-0578
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mild Traumatic Brain Injury, Post Traumatic Stress Disorder, mTBI, PTSD, intermittent theta burst stimulation, cognitive training, neuroimaging