Persistent Post Concussion SyndromeNCT07246993
Targeting Neuroplasticity for Persistent Post-Concussive Cognitive Symptoms
A study testing Active tDCS in people with Persistent Post Concussion Syndrome and Mild Traumatic Brain Injury, run by University of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Persistent Post Concussion Syndrome, Mild Traumatic Brain Injury
- What is being tested?
- Active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Melanie Stimac, 612-301-2549, stima011@umn.edu
About this study
Official title: 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).
- Being tested
- Active tDCS, Sham tDCS
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS + Cognitive Training | Active comparator | Not described Receives: Device: Active tDCS |
| Sham tDCS + Cognitive Training | Placebo comparator | Not described Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Ecological Momentary Assessment Survey score
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start5 Mar 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Post Concussion SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind, randomized, sham-controlled clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jazmin Camchong, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246993
- Sponsor's protocol ID
- PSYCH-2025-34246
- Status last verified
- Aug 2026
- First submitted
- 30 Oct 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Neuroplasticity for Persistent Post-Concussive Cognitive Symptoms: A Trial of tDCS and Cognitive Training 3-12 Months Post-mTBI
- ClinicalTrials.gov ID
- NCT07246993
- Acronym / sponsor ID
- PSYCH-2025-34246
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double-blind, randomized, sham-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Active tDCS + Cognitive Training | Active comparator | Device: Active tDCS |
| Sham tDCS + Cognitive Training | Placebo comparator | Device: Sham tDCS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active tDCSAll 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 | Active tDCS + Cognitive Training |
| Sham tDCSAll 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. | Device | Sham tDCS + Cognitive Training |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Persistent Post Concussion Syndrome
Not yet recruiting
Electroencephalography Markers of Brain Stimulation in Post-Concussion Patients
Patients With Persistent Post-concussion Symptoms
Active, not recruiting
Move&Connect: A Program for Youth With Concussion and Their Caregivers.
Post-Concussion Syndrome
RecruitingPhase 2
Hyperbaric Oxygen Therapy for Veterans With TBI and PCS: A Biomarker Study
Traumatic Brain Injury (TBI) Patients, Post Concussive Symptoms
Recruiting
Effects of tDCS for Enhancing Cognitive Function in Individuals With Persistent Post-Concussion Syndrome
Transcranial Direct Current Stimulation, Post-Concussion Syndrome
RecruitingPhase 2/3
Randomized Controlled Trial of Treatment to Optimize Heart Rate Variability for Persistent Post-Concussion Symptoms
Autonomic Nervous System Disease, Concussive Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jazmin Camchong, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS in people with Persistent Post Concussion Syndrome and Mild Traumatic Brain Injury, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melanie Stimac (612-301-2549, stima011@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.