Targeting Neuroplasticity for Persistent Post-Concussive Cognitive Symptoms

Targeting Neuroplasticity for Persistent Post-Concussive Cognitive Symptoms: A Trial of tDCS and Cognitive Training 3-12 Months Post-mTBI

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).

Study Overview

• Status: Recruiting
• Conditions: Mild Traumatic Brain Injury; Persistent Post Concussion Syndrome
• Intervention / Treatment: Device: Active tDCS; Device: Sham tDCS

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melanie Stimac; Phone Number: 612-301-2549; Email: stima011@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
      • Contact: Melanie Stimac; Phone Number: 612-301-2549; Email: stima011@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active tDCS + Cognitive Training	Device: 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.
Placebo Comparator: Sham tDCS + Cognitive Training	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of active tDCS combined with cognitive training compared to sham tDCS combined with cognitive training for improving executive function in individuals with PPCS	Using score on Penn Cognitive Battery	Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of active versus sham tDCS combined with cognitive training on self-reported affect, stress, cognition, and objectively measured sleep and activity levels	Ecological Momentary Assessment Survey score	Week 4

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Kelvin Lim, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: October 30, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Concussion
• Other Study ID Numbers: PSYCH-2025-34246

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes