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

Not yet recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

46

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

VA Office of Research and Development

Investigators

  • 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)

May 24, 2027

Primary Completion (Estimated)

November 26, 2029

Study Completion (Estimated)

November 30, 2030

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

February 9, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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