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Recruiting NCT07246993

Targeting Neuroplasticity for Persistent Post-Concussive Cognitive Symptoms

No phase Interventional Persistent Post Concussion Syndrome Mild Traumatic Brain Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active tDCS, Sham tDCS.
Who it may be relevant to
Registry conditions: Persistent Post Concussion Syndrome, Mild Traumatic Brain Injury. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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).

Interventions

  • 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
  • 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

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Effects of active versus sham tDCS combined with cognitive training on self-reported affect, stress, cognition, and objectively measured sleep and activity levels [Time frame: Week 4]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Minnesota — Minneapolis

Identifiers

NCT: NCT07246993 · PSYCH-2025-34246

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗