Remotely Administered tDCS to Improve Cognitive Function in Veterans With mTBI and PTSD Principal Investigator

February 9, 2026 updated by: VA Office of Research and Development

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4551
        • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
        • Contact:
        • Principal Investigator:
          • Kelly L Sloane, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: tDCS
Active transcranial direct current stimulation (tDCS)
Device: 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.
Other: Cognitive training
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.
Sham Comparator: Sham tDCS
Sham transcranial direct current stimulation (tDCS)
Device: 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.
Other: Cognitive training
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Pre- and post-intervention (immediate and 2 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difficulties in Emotion Regulation Scale (DERS)
Time Frame: Pre- and post-intervention (immediate and 2 months)
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.
Pre- and post-intervention (immediate and 2 months)
Glasgow Coma Scale-Extended (GOSE)
Time Frame: Pre- and post-intervention (immediate and 2 months)
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).
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)
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.
Pre- and post-intervention (immediate and 2 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kelly L Sloane, PhD, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 24, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 26, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RRD9-012-25M
  • 1-IK2-RD-000464-01-A2 (Other Grant/Funding Number: VA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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).

IPD Sharing Time Frame

After completion of study protocol.

IPD Sharing Access Criteria

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).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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