Study for Traumatic Brain Injury and Cognitive Training
This study is looking for Veterans and Warfighters aged 18-59 who experienced a mild traumatic brain injury (TBI) between 3 months and 5 years ago and are still having cognitive problems. The study aims to improve thinking skills by combining Attention Process Training (APT) with either transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (HD-tDCS). rTMS uses magnetic fields to stimulate the brain, while HD-tDCS uses gentle electrical currents. Researchers will measure changes in your cognitive symptoms, objective thinking abilities, and overall quality of life over 4 weeks of treatment and then for 3 and 6 months afterward. The study is currently recruiting 108 participants, but its overall status is unclear.
- Study design
- This is a randomized, double-blinded, sham-controlled Phase II clinical trial involving 108 participants.
- What's involved
- You would have baseline visits for testing, MRI scans, and brain imaging. You would then receive treatment for 4 weeks, followed by long-term follow-up visits at 3 and 6 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 3 and 6 months after treatment to assess long-term quality of life.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Control Network Neuromodulation to Enhance Cognitive Training in Complex Traumatic Brain Injury
At a glance
Conditions
Where it's being run
5 sites across 2 statesStudy leadership
- Davin k Quinn, MD, FACLP · PRINCIPAL_INVESTIGATOR · University of New Mexico
Who to contact
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What this trial measures
- Primary symptom outcome: Change from baseline in cognitive PCS as measured by the NSI cognitive subscale score at post-treatment.Baseline and post-treatment visits, 4 weeks
Post-concussive symptoms will be measured with the Neurobehavioral Symptom Inventory (NSI). This assessment will be administered at the baseline and post-treatment visits. The NSI is a self-report questionnaire that consists of 22 non-specific complaints commonly reported after concussion and is used to quantify traumatic brain injury (TBI) symptom severity and select symptoms for treatment. The NSI asks the patient to rate each of the symptoms according to how much the symptom has disturbed him/her using a five point scale. Patient ratings are based on descriptions of the frequency of the symptom, the extent to which the symptom disrupts the patient's activities, and the patient's perceived need for help with the symptom. The 22 individual symptoms items are weighted equally. The cognitive subscale score uses 4 items, where a higher score means more severe symptoms and a lower score means less severe symptoms. The minimum value is 0, and the maximum value is 16
- Primary cognitive outcome: Change from baseline in objective cognitive control as measured by accuracy on the Multi-modal Working Memory N-back task (MMWM) to post-treatment Visit.Baseline and post-treatment visits, 4 weeks
The MMWM is a continuous performance test in which subjects respond to simultaneous sequences of visual (squares on a grid) and auditory (spoken numbers) stimuli by pressing a button if stimuli in either or both sensory modalities match a previous stimulus (1-back or 2-back).
- Primary functional outcome: Change from post-treatment visit in overall quality of life as measured by the PGIC at long-term follow-up at 3 and 6 months.Post-treatment visit and long-term follow-up at 3 and 6 months
The Patient Global Impression of Change (PGIC) is a self-report scale that reflects a patient's belief about the efficacy of treatment. The PGIC is a 7 point scale depicting a patient's rating of overall improvement, where a 1 is no change and a 7 is a great deal of change.
- Primary imaging outcome: Change (decrease) in CCN activity from Baseline Visit to Post-treatment Visit as measured by the BOLD signal during the MMWM task performance.Baseline and post-treatment visits, 4 weeks
The blood oxygen level-dependent (BOLD) signal will be measured during the MMWM task performance to determine correlation with symptom improvement on NSI. The BOLD signal will be measured at the baseline and post-treatment MRIs.