NCT07246993 · University of Minnesota
Targeting Neuroplasticity for Persistent Post-Concussive Cognitive Symptoms
What this study is about
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).
View original scientific description
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 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.
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.
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
Using score on Penn Cognitive Battery
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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)
Where
- Minneapolis, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 17, 2026 · Source of record for eligibility and locations