Condition: Traumatic Brain Injury · Sponsor: University of New Mexico
The CONNECT-TBI Trial aims to develop safe, effective treatments for complex mTBI that improve cognitive functioning. Based on the compelling preliminary data generated by our study team, the objective of this study is to conduct a randomized, double-blinded, sham-controlled Phase II clinical trial of APT-3 combined with rTMS, HD-tDCS, or sham to treat cognitive control deficits in Veterans with complex mTBI and PPCS. At the Baseline Visit, participants will undergo demographic, neuropsychological, behavioral, and quality of life testing. They will also undergo structural MRI to permit modeling of their brain, resting/task-related fMRI to identify the CCN, and pseudocontinuous arterial spin labeling (pCASL) and diffusion tensor imaging (DTI) to assess for other pathologies. They will then be randomized to 16 sessions of APT-3 with concurrent rTMS, HD-tDCS, or sham stimulation delivered to the unique functional left dorsolateral prefrontal cortex (DLPFC), a primary node of the CCN. Lastly, they will repeat all baseline tests, and report on 3- and 6-month recovery levels to establish longevity and stability of subjective benefit. Given that this individualization protocol has never been attempted for cognitive rehabilitation in military mTBI, we expect this trial will generate useful effect sizes for HD-tDCS and rTMS to be used for powering the next step, a Phase III multi-center trial.
This description comes directly from the study's public registry record.
Cesar J Ojeda, MBA · (505)272-6972 · cojeda1@salud.unm.edu
Davin k Quinn, MD, FACLP · (505)272-2223 · dquinn@salud.unm.edu
Always discuss trial participation with your own doctor first.
| Minneapolis Veterans Affairs Medical Center | Minneapolis, Minnesota, United States | Recruiting |
| The University of Minnesota | Minneapolis, Minnesota, United States | Active Not Recruiting |
| The Mind Research Network | Albuquerque, New Mexico, United States | Active Not Recruiting |
| The University of New Mexico | Albuquerque, New Mexico, United States | Active Not Recruiting |
| New Mexico Veterans Affairs Health Care System | Albuquerque, New Mexico, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05236010