Control Network Neuromodulation to Enhance Cognitive Training in Complex Traumatic Brain Injury (NCT05236010)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Minneapolis Veterans Affairs Medical Center — Minneapolis, Minnesota
Age range: 18 Years to 59 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (5 Sites)
- Minneapolis Veterans Affairs Medical Center — Minneapolis, Minnesota
- The University of Minnesota — Minneapolis, Minnesota
- The Mind Research Network — Albuquerque, New Mexico
- The University of New Mexico — Albuquerque, New Mexico
- New Mexico Veterans Affairs Health Care System — Albuquerque, New Mexico
📞 Contact the Study Coordinator
Phone: (505) 272-6972
Email: cojeda1@salud.unm.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Traumatic Brain Injury
- Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI) — San Francisco, California
- Improving Time-Based Prospective Memory in TBI — East Hanover, New Jersey
- Re-entry Continuum for Brain Injury — Greencastle, Indiana
- Transcranial Direct Current Stimulation (TDCS) as an Intervention for Patients With Traumatic Brain Injury — Minneapolis, Minnesota
- TRACK-TBI Longitudinal Biomarker Study — San Francisco, California
- Narrative Discourse Treatment Development — West Haven, Connecticut
Explore by condition: All Traumatic Brain Injury clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.