CognitionPhase 2NCT07414537
Remotely Administered tDCS to Improve Cognitive Function in Veterans With mTBI and PTSD Principal Investigator
A Phase 2 study testing Transcranial direct current stimulation (tDCS) and Cognitive training in people with Cognition and Brain Injuries, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD) are common combat-related conditions that can result in impairments in cognition, including memory, attention and multi-tasking. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Cognition, Brain Injuries, Stress Disorders, Post-Traumatic
- What is being tested?
- Transcranial direct current stimulation (tDCS) and Cognitive training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2027to 30 Nov 2030
- Phase
- Phase 2
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of chronic mTBI as measured by Ohio State University Traumatic Brain Injury Identification Method
- mTBI occurred > 5 years prior to study enrollment
- History of PTSD with symptoms within the last month as confirmed PTSD Checklist (past month) score greater than or equal to 33,
- Cognitive impairment as defined by telephone Montreal Cognitive Assessment < 19
- No history of reported or documented age-related or neurodegenerative condition
- Access to internet for 1 hour per day
- Willing and able to comply with all study related procedures and capable of independently reading and understanding study materials and providing informed consent.
Who cannot join
- Skin lesions at the stimulation site that may increase conductance
- Metallic objects in the face or head (e.g. braces, fillings, implants)
- Pregnancy/lactation or planning to become pregnant during study
- History of other significant neurological disorders including seizure disorder, central nervous system tumors, stroke, cerebral aneurysm
- History of primary psychotic disorder, bipolar I disorder, active substance use disorder (moderate or greater, measured by Drug Abuse Screening Test-10)
- Active suicidal intent or plan, measured by Columbia-Suicide Severity Rating Scale
- Other conditions or circumstances that, in the opinion of investigator team, have the potential to prevent completion and/or have a confounding effect on outcome assessments.
- Unable to tolerate 2mA transcranial direct current stimulation (tDCS)
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
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104-4551
Kelly L Sloane, PhD, 215-823-5800, kelly.sloane@va.gov
Kelly L Sloane, PhD
About this study
Official title: Remotely Administered tDCS to Improve Cognitive Function in Veterans With mTBI and PTSD
Traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD) are common combat-related conditions that can result in impairments in cognition, including memory, attention and multi-tasking. There are few effective interventions to improve cognition in Veterans with cognitive impairment due to these conditions. Non-invasive brain stimulation techniques, like transcranial direct current stimulation (tDCS), can be used to stimulate activity in areas of the brain to optimize recovery and rehabilitation. In this study, the investigators are conducting a randomized controlled trial of tDCS to improve cognitive function in Veterans with cognitive impairment due to co-morbid TBI and PTSD. TDCS is remotely administered and paired with cognitive training.
Read the detailed description
This study is a double blinded randomized controlled trial of transcranial direct current stimulation (tDCS) to improve cognitive function in Veterans with cognitive impairment due to co-morbid traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD). Eligible Veterans who choose to enroll will be randomized to active or sham stimulation with tDCS. They will undergo 10 weekdays of stimulation (active or sham) paired with cognitive training with the mobile application BrainHQ that will be conducted remotely. The Veteran and a friend/family/caregiver will be trained to perform tDCS using devices that are designed for remote use and supplied with materials necessary to conduct stimulation. A member of research staff will be on videoconferencing (i.e. HIPAA compliant VVC) with the participant to ensure proper setup of the device and be available for any questions that may arise during the session. They will undergo cognitive testing at 3 timepoints: prior to initiation of the first stimulation visit, after the last stimulation visit and 2 months after stimulation completion.
- Conditions
- Cognition, Brain Injuries, Stress Disorders, Post-Traumatic
- Being tested
- Transcranial direct current stimulation (tDCS), Cognitive training
- Keywords
- Cognitive impairment, Rehabilitation, Neuromodulation
- Medical subject headings
- Brain Injuries, Stress Disorders, Post-Traumatic, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (tDCS)Device
Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation. Participants will be randomized to active tDCS or sham tDCS for 20 minutes per day for 10 consecutive weekdays.
Cognitive trainingOther
Participants in both arms will undergo cognitive training while tDCS (Active or Sham) is being administered. Cognitive exercises will be completed through the mobile application BrainHQ.
| Study group | Role | What they receive |
|---|---|---|
| tDCS | Active comparator | Active transcranial direct current stimulation (tDCS) Receives: Device: Transcranial direct current stimulation (tDCS); Other: Cognitive training |
| Sham tDCS | Sham comparator | Sham transcranial direct current stimulation (tDCS) Receives: Device: Transcranial direct current stimulation (tDCS); Other: Cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIH Toolbox Fluid Composite score
The NIH Toolbox Fluid Composite score consists of Dimensional Change Card Sort, Flanker Inhibitory Control and Attention, Picture Sequence Memory, List Sorting Working Memory, and Pattern Comparison. Normative data have been recently updated (in 2021) to reflect population demographics in terms of age, biological sex, race/ethnicity, education and geography and each test yields t-scores metrics corrected for age and other demographic characteristics (education, sex, race/ethnicity). Scores range between 0 and 100 with higher scores indicating better cognitive performance.
Measured: Pre- and post-intervention (immediate and 2 months)
Secondary outcomes (3)
Difficulties in Emotion Regulation Scale (DERS)
DERS is self-report measure consisting of 36 items assessing awareness and understanding of one's emotions, acceptance of negative emotions, the ability to successfully engage in goal-directed behavior and control impulsive behavior when experiencing negative emotions, and the ability to use situationally appropriate emotion regulation strategies. It has strong psychometric properties and has been validated in individuals with military combat experience. Scoring is based on responses [from 1 (almost never) to 5 (almost always)] to each item based on how well the item describes the individual, where higher scores represent more emotional dysregulation.
Measured: Pre- and post-intervention (immediate and 2 months)
Glasgow Coma Scale-Extended (GOSE)
GOSE is a validated tool for classifying global outcomes in TBI survivors. It is an 8-point range with scores ranging from 1 (Death) to 8 (Upper Good Recovery).
Measured: Pre- and post-intervention (immediate and 2 months)
Quality of Life after Brain Injury Overall Scale (QOLIBRI-OS)
Patient reported outcome measure with the total score ranging from 0 to 100, where 0 represents the lowest and 100 represents the highest possible quality of life.
Measured: Pre- and post-intervention (immediate and 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start24 May 2027 (estimated)
- Primary completion26 Nov 2029 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded randomized controlled trial of the device transcranial direct current stimulation (tDCS)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kelly L Sloane, PhD, Principal investigator, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414537
- Sponsor's protocol ID
- RRD9-012-25M
- Other IDs
- 1IK2RD000464-01A2
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After completion of the study, de-identified and HIPAA complaint data will be shared with investigators who contact the PI and submit a formal request for access (outlining their research proposal, methods and justification for data access).
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remotely Administered tDCS to Improve Cognitive Function in Veterans With mTBI and PTSD
- ClinicalTrials.gov ID
- NCT07414537
- Acronym / sponsor ID
- RRD9-012-25M
- Conditions
- Cognition, Brain Injuries, Stress Disorders, Post-Traumatic
- Keywords
- Cognitive impairment, Rehabilitation, Neuromodulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 24 May 2027 (estimated)
- Primary completion
- 26 Nov 2029 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 17 Feb 2026 (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.
Traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD) are common combat-related conditions that can result in impairments in cognition, including memory, attention and multi-tasking. There are few effective interventions to improve cognition in Veterans with cognitive impairment due to these conditions. Non-invasive brain stimulation techniques, like transcranial direct current stimulation (tDCS), can be used to stimulate activity in areas of the brain to optimize recovery and rehabilitation. In this study, the investigators are conducting a randomized controlled trial of tDCS to improve cognitive function in Veterans with cognitive impairment due to co-morbid TBI and PTSD. TDCS is remotely administered and paired with cognitive training.
Detailed description
This study is a double blinded randomized controlled trial of transcranial direct current stimulation (tDCS) to improve cognitive function in Veterans with cognitive impairment due to co-morbid traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD). Eligible Veterans who choose to enroll will be randomized to active or sham stimulation with tDCS. They will undergo 10 weekdays of stimulation (active or sham) paired with cognitive training with the mobile application BrainHQ that will be conducted remotely. The Veteran and a friend/family/caregiver will be trained to perform tDCS using devices that are designed for remote use and supplied with materials necessary to conduct stimulation. A member of research staff will be on videoconferencing (i.e. HIPAA compliant VVC) with the participant to ensure proper setup of the device and be available for any questions that may arise during the session. They will undergo cognitive testing at 3 timepoints: prior to initiation of the first stimulation visit, after the last stimulation visit and 2 months after stimulation completion.
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 blinded randomized controlled trial of the device transcranial direct current stimulation (tDCS)
| Arm | Type | Receives |
|---|---|---|
| tDCS | Active comparator | Device: Transcranial direct current stimulation (tDCS), Other: Cognitive trainingActive transcranial direct current stimulation (tDCS) |
| Sham tDCS | Sham comparator | Device: Transcranial direct current stimulation (tDCS), Other: Cognitive trainingSham transcranial direct current stimulation (tDCS) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- History of chronic mTBI as measured by Ohio State University Traumatic Brain Injury Identification Method
- mTBI occurred > 5 years prior to study enrollment
- History of PTSD with symptoms within the last month as confirmed PTSD Checklist (past month) score greater than or equal to 33,
- Cognitive impairment as defined by telephone Montreal Cognitive Assessment < 19
- No history of reported or documented age-related or neurodegenerative condition
Key exclusion criteria (8 listed)
- Skin lesions at the stimulation site that may increase conductance
- Metallic objects in the face or head (e.g. braces, fillings, implants)
- Pregnancy/lactation or planning to become pregnant during study
- History of other significant neurological disorders including seizure disorder, central nervous system tumors, stroke, cerebral aneurysm
- History of primary psychotic disorder, bipolar I disorder, active substance use disorder (moderate or greater, measured by Drug Abuse Screening Test-10)
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 |
|---|---|---|
| Transcranial direct current stimulation (tDCS)Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation. Participants will be randomized to active tDCS or sham tDCS for 20 minutes per day for 10 consecutive weekdays. | Device | Sham tDCS, tDCS |
| Cognitive trainingParticipants in both arms will undergo cognitive training while tDCS (Active or Sham) is being administered. Cognitive exercises will be completed through the mobile application BrainHQ. | Other | Sham tDCS, tDCS |
Primary outcome
NIH Toolbox Fluid Composite score
Time frame: Pre- and post-intervention (immediate and 2 months)
The NIH Toolbox Fluid Composite score consists of Dimensional Change Card Sort, Flanker Inhibitory Control and Attention, Picture Sequence Memory, List Sorting Working Memory, and Pattern Comparison. Normative data have been recently updated (in 2021) to reflect population demographics in terms of age, biological sex, race/ethnicity, education and geography and each test yields t-scores metrics corrected for age and other demographic characteristics (education, sex, race/ethnicity). Scores range between 0 and 100 with higher scores indicating better cognitive performance.
3 secondary outcomes
Difficulties in Emotion Regulation Scale (DERS)
Time frame: Pre- and post-intervention (immediate and 2 months)
Glasgow Coma Scale-Extended (GOSE)
Time frame: Pre- and post-intervention (immediate and 2 months)
Quality of Life after Brain Injury Overall Scale (QOLIBRI-OS)
Time frame: Pre- and post-intervention (immediate and 2 months)
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 17 Feb 2026.
- Individual participant dataSharing planned: Yes. After completion of the study, de-identified and HIPAA complaint data will be shared with investigators who contact the PI and submit a formal request for access (outlining their research proposal, methods and justification for data access).
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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.
Kelly L Sloane, PhD principal investigator
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transcranial direct current stimulation (tDCS) and Cognitive training in people with Cognition and Brain Injuries, run by VA Office of Research and Development 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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 17 Feb 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Kelly L Sloane, PhD ((215) 823-5800, kelly.sloane@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIH Toolbox Fluid Composite score (time frame: Pre- and post-intervention (immediate and 2 months)). 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 17 Feb 2026.