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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of New Mexico
Study ID
NCT05236010
Status
Recruiting
Apply to this trial

Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 59 Years
Healthy Volunteers
Not accepted

Interventions

  • rTMS — DEVICE
    Transcranial magnetic stimulation is a noninvasive form of brain stimulation in which a changing magnetic field is used to cause electric current at a specific area of the brain through electromagnetic induction. During an rTMS session, an electromagnetic coil is placed against the scalp near the forehead. The electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the region of the brain being targeted.
  • HD-tDCS — DEVICE
    Transcranial direct current stimulation (tDCS), is a non-invasive, painless brain stimulation treatment that uses direct electrical currents to stimulate specific parts of the brain. A constant, low intensity current is passed through two electrodes placed over the head which modulates neuronal activity.
  • Attention Process Training — OTHER
    Attention Process Training (APT) is a multi-session exercise designed to help improve the ability to focus on relevant material while ignoring irrelevant distractions. Further, it helps improve the speed of processing information.

Study Details

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.

Key Dates

Start date
Jan 21, 2022
Status verified
May 2026
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
108 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active rTMS with Attention Process Training
    Subjects in this arm will receive active rTMS and then complete the assigned Attention Process Training battery immediately following active rTMS.
  • Sham Comparator: Sham rTMS with Attention Process Training
    Subjects in this sham arm will not receive any active stimulation and will only complete Attention Process Training immediately following sham rTMS.
  • Active Comparator: Active HD-tDCS with Attention Process Training
    Subjects in this arm will receive active HD-tDCS and complete the assigned Attention Process Training battery during active HD-tDCS.
  • Sham Comparator: Sham HD-tDCS with Attention Process Training
    Subjects in this sham arm will not receive any active stimulation and will only complete Attention Process Training during sham HD-tDCS.

Primary Outcome Measure

Primary symptom outcome: Change from baseline in cognitive PCS as measured by the NSI cognitive subscale score at post-treatment. [ Time Frame: Baseline and post-treatment visits, 4 weeks ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Minneapolis Veterans Affairs Medical CenterMinneapolisMinnesota55417
Sloan Davidson, MS
[email protected]
The University of MinnesotaMinneapolisMinnesota55455-
New Mexico Veterans Affairs Health Care SystemAlbuquerqueNew Mexico87108
JoAnn Harnar
[email protected]
The Mind Research NetworkAlbuquerqueNew Mexico87106-
The University of New MexicoAlbuquerqueNew Mexico87106-

Find similar trials in Minneapolis, MN

By research site
Minneapolis Veterans Affairs Medical Center· Minneapolis, MNThe University of Minnesota· Minneapolis, MNNew Mexico Veterans Affairs Health Care System· Albuquerque, NMThe Mind Research Network· Albuquerque, NMThe University of New Mexico· Albuquerque, NM

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