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Control Network Neuromodulation to Enhance Cognitive Training in Complex Traumatic Brain Injury

Study acronym: CONNECT-TBI
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 21, 2026 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.
Trial flagged as At Risk
Primary completion moved at least 3 months later across 2 updates Jul 1, 2026 → Oct 1, 2026
See other at-risk trials from University of New Mexico

Record History

  1. Primary and study completion pushed from Aug 1, 2026 to Oct 1, 2026v9
  2. Primary and study completion pushed from Jul 1, 2026 to Aug 1, 2026v8
  3. Primary and study completion dates: Apr 1, 2026 to Jul 1, 2026v7
  4. Primary and study completion dates: Oct 1, 2025 to Apr 1, 2026v6
  5. Re-verified, no change to tracked fieldsv5
Show 3 earlier versionsHide 3 earlier versions
  1. Primary completion date: Oct 1, 2024 to Oct 1, 2025v4
  2. Primary completion date: Nov 2023 to Oct 1, 2024 Completion date: Nov 2024 to Oct 1, 2025v3 Show 1 more changeShow less
    • Completion date: Nov 2024 to Oct 1, 2025
  3. Collaborators: 5 to 4 Eligibility criteria expanded, about 5 wordsv2 Show 1 more changeShow less
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05236010
Lead Sponsor University of New Mexico
Collaborators: The Mind Research Network, New Mexico VA Healthcare System, Minneapolis Veterans Affairs Medical Center, University of Minnesota
Conditions Traumatic Brain Injury
Enrollment 108 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov