Recruiting

tDCS & Cognitive Training

Sponsor:

University of Minnesota

Code:

NCT07246993

Conditions

Persistent Post Concussion Syndrome

Mild Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Active tDCS

Sham tDCS

Study Details

Brief summary:

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).

Conditions

Persistent Post Concussion Syndrome

Mild Traumatic Brain Injury

Study ID

NCT07246993

Start date

Mar 5, 2026

Status verified date

Aug, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18-65
  • Has sustained a single mTBI 3-12 months prior to enrollment
  • Meets criteria for PPCS (assessed using the CP Screen)
  • Has reliable access to a smartphone

Exclusion Criteria:

  • Inability to provide informed consent or complete study procedures
  • History of moderate/severe TBI
  • Significant neurological or psychiatric disorders (other than PPCS-related symptoms like mild depression/anxiety)
  • Substance dependence within the last six months
  • Contraindications to tDCS (e.g., implanted metal, skin lesions on scalp)

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active tDCS + Cognitive Training

placebo comparator: Sham tDCS + Cognitive Training

Interventions

Active tDCS

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

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.

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 and Locations

Central contacts

Melanie Stimac

612-301-2549stima011@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Melanie Stimac

612-301-2549stima011@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-09-01.