Targeting Neuroplasticity for Persistent Post-Concussive Cognitive Symptoms

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT07246993
Status
Recruiting

Conditions

  • Mild Traumatic Brain Injury
  • Persistent Post Concussion Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Active tDCS — DEVICE
    All participants will receive 10 sessions of cognitive training focused on executive functions, delivered over approximately 3 weeks. Cognitive training will be completed on a lab provided computer using PositScience BrainHQ or TaskFlow software. Concurrently, during each training session, participants will receive either active or sham tDCS. Stimulation will be delivered via saline-soaked sponge electrodes using the Soterix 1x1 miniCT TES device. The anode (active electrode) will be placed over the L-DLPFC (approximated by EEG coordinate F3) and the cathode (reference electrode) over the contralateral supraorbital area (Fp2). The active tDCS group will receive 2mA constant current for 20 minutes.
  • Sham tDCS — DEVICE
    All participants will receive 10 sessions of cognitive training focused on executive functions, delivered over approximately 3 weeks. Cognitive training will be completed on a lab provided computer using PositScience BrainHQ or TaskFlow software. Concurrently, during each training session, participants will receive either active or sham tDCS. Stimulation will be delivered via saline-soaked sponge electrodes using the Soterix 1x1 miniCT TES device. The anode (active electrode) will be placed over the L-DLPFC (approximated by EEG coordinate F3) and the cathode (reference electrode) over the contralateral supraorbital area (Fp2). The sham tDCS group will receive a brief ramp up and ramp down of current at the beginning and end of the 20 minutes to mimic the sensation of active stimulation.

Study Details

This project investigates an innovative combination of non-invasive neuromodulation (transcranial direct current stimulation - tDCS) and cognitive training as a novel treatment approach aimed at improving function in individuals suffering from persistent post-concussive syndrome (PPCS) following mild traumatic brain injury (mTBI).

Key Dates

Start date
Mar 5, 2026
Status verified
Mar 2026
Primary completion
Jan 1, 2028
Completion
Jan 1, 2028

Study Design

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

Arms

  • Active Comparator: Active tDCS + Cognitive Training
  • Placebo Comparator: Sham tDCS + Cognitive Training

Primary Outcome Measure

Efficacy of active tDCS combined with cognitive training compared to sham tDCS combined with cognitive training for improving executive function in individuals with PPCS [ Time Frame: Week 4 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455
Melanie Stimac
612-301-2549

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