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NCT05236010 · ClinicalTrials.gov registry record · NA
Control Network Neuromodulation to Enhance Cognitive Training in Complex Traumatic Brain Injury
A NA study of Traumatic Brain Injury, sponsored by University of New Mexi.
- Recruiting
- Registry status
- NA
- Development phase
- 108
- Enrollment target
- 5
- Study locations
NCT05236010: Recruiting NA study of Traumatic Brain Injury, sponsored by University of New Mexi.
NCT05236010 is a NA study of Traumatic Brain Injury that is actively recruiting participants, run by University of New Mexi. The registered enrollment target is 108 participants, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (61% lower). The trial reports 5 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05236010, a NA study of Traumatic Brain Injury, is actively recruiting participants, sponsored by University of New Mexi.
- RECRUITING
- Registry status
- NA
- Development phase
- 108 participants
- Enrollment target
- 5
- Study locations
Study 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 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.
Primary Outcome
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
Conditions Studied
Interventions
- DEVICE rTMS
- DEVICE HD-tDCS
- OTHER Attention Process Training
Study Locations (5)
New Mexico
- The Mind Research Network - Albuquerque
- The University of New Mexico - Albuquerque
- New Mexico Veterans Affairs Health Care System - Albuquerque
Minnesota
- Minneapolis Veterans Affairs Medical Center - Minneapolis
- The University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2022-01-21 |
| Est. Completion | 2026-04-01 |
| Phase | NA |
What NCT05236010 shows while recruiting
NCT05236010 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Traumatic Brain Injury appearing as the primary indexed condition, and to 3 interventions - of which rTMS is the first listed.
NCT05236010 lists 5 locations in 2 states (New Mexico, Minnesota).
Frequently Asked Questions
What is clinical trial NCT05236010 about?
NCT05236010 is a clinical study titled "Control Network Neuromodulation to Enhance Cognitive Training in Complex Traumatic Brain Injury". 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 ...
What is the current status of trial NCT05236010?
This trial is currently recruiting. It is a NA study. The enrollment target is 108 participants. The study started on 2022-01-21. Estimated completion is 2026-04-01.
What conditions does trial NCT05236010 study?
This clinical trial studies the following conditions: Traumatic Brain Injury.
What interventions are being tested in trial NCT05236010?
The interventions under investigation include: rTMS (DEVICE), HD-tDCS (DEVICE), Attention Process Training (OTHER).
Who is sponsoring clinical trial NCT05236010?
This trial is sponsored by University of New Mexi, which has 76 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05236010 being conducted?
This trial has 5 study locations across Minnesota, New Mexico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05236010's enrollment target sits among peer trials
108 65th of 171 higher than 106 of 171 other Traumatic Brain Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Traumatic Brain Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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