NCT07246993

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Mar 2026Jan 2028

First Submitted

Initial submission to the registry

October 30, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

March 5, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

October 30, 2025

Last Update Submit

March 16, 2026

Conditions

Persistent Post Concussion SyndromeMild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Effects of active versus sham tDCS combined with cognitive training on self-reported affect, stress, cognition, and objectively measured sleep and activity levels

    Week 4

Study Arms (2)

Active tDCS + Cognitive Training

ACTIVE COMPARATOR
Device: Active tDCS

Sham tDCS + Cognitive Training

PLACEBO COMPARATOR
Device: Sham tDCS

Interventions

Active tDCSDEVICE

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.

Active tDCS + Cognitive Training
Sham tDCSDEVICE

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.

Sham tDCS + Cognitive Training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Kelvin Lim, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Melanie Stimac

CONTACT

612-301-2549stima011@umn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: double-blind, randomized, sham-controlled clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2025

First Posted

November 25, 2025

Study Start

March 5, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)