Control Network Neuromodulation to Enhance Cognitive Training in Complex Traumatic Brain I
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 wi
| Condition(s) | Traumatic Brain Injury |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | Inclusion Criteria: There will be no gender restrictions with regard to sample inclusion. Veterans and Warfighters will be enrolled in this study if they 1) are aged 18-59; 2) have suffered a mild TBI with documented evidence of alteration in neurological functioning or loss of consciousness (LOC) which was less than 30 minutes; 3) were injured between 3 months and 5 years ago; 4) experienced less than 24 hours of post-traumatic amnesia (PTA); 5) have subjective post-TBI cognitive deficits as assessed by the NSI, with at least 1 of 4 cognitive symptoms at a score of 3 or higher (severe disturbance) or at least 2 of 4 cognitive symptoms at a score of 2 or higher (moderate disturbance). This is the target population as identified by the grant mechanism, with chronic cognitive impairments fro |
| Ages | 18 Years to 59 Years |
| Sex | All |
| Lead sponsor | University of New Mexico |
| Locations | Minneapolis, Minnesota, United States; Minneapolis, Minnesota, United States; Albuquerque, New Mexico, United States; Albuquerque, New Mexico, United States; Albuquerque, New Mexico, United States |
| Start date | 2022-01-21 |
| NCT ID | NCT05236010 |
| Official listing | https://clinicaltrials.gov/study/NCT05236010 |