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

NCT07414537 | Not Yet Recruiting Phase 2

• 2 other identifiers: RRD9-012-25M1-IK2-RD-000464-01-A2
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cognition; Brain Injuries; Stress Disorders, Post-Traumatic

Keywords

Cognitive impairment; Rehabilitation; Neuromodulation

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre- and post-intervention (immediate and 2 months)

Secondary Outcomes (3)

• Difficulties in Emotion Regulation Scale (DERS)

  Pre- and post-intervention (immediate and 2 months)

• Glasgow Coma Scale-Extended (GOSE)

  Pre- and post-intervention (immediate and 2 months)

• Quality of Life after Brain Injury Overall Scale (QOLIBRI-OS)

  Pre- and post-intervention (immediate and 2 months)

Study Arms (2)

tDCS

ACTIVE COMPARATOR

Active transcranial direct current stimulation (tDCS)

Device: Transcranial direct current stimulation (tDCS); Other: Cognitive training

Sham tDCS

SHAM COMPARATOR

Sham transcranial direct current stimulation (tDCS)

Device: Transcranial direct current stimulation (tDCS); Other: Cognitive training

Interventions

Cognitive training OTHER

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 tDCS; tDCS

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.

Sham tDCS; tDCS

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104-4551, United States

Location

MeSH Terms

Conditions

Brain Injuries; Stress Disorders, Post-Traumatic; Cognitive Dysfunction

Interventions

Transcranial Direct Current Stimulation; Cognitive Training

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Kelly L Sloane, PhD

  Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly L Sloane, PhD

CONTACT

(215) 823-5800; kelly.sloane@va.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All study staff and participants will be blinded to study condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Double blinded randomized controlled trial of the device transcranial direct current stimulation (tDCS)

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start (Estimated): May 24, 2027
• Primary Completion (Estimated): November 26, 2029
• Study Completion (Estimated): November 30, 2030
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After completion of study protocol.
• 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).

Locations

US (1)