Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT07414537

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

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

Status
Not Yet Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
46 (estimated)
Sponsor
VA Office of Research and Development · Federal
Sex
All
Age
20 Years – 75 Years
Healthy volunteers
Not accepted

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.

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

Interventions

TypeNameDescription
DEVICETranscranial 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.
OTHERCognitive 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.

Timeline

Start date
2027-05-24
Primary completion
2029-11-26
Completion
2030-11-30
First posted
2026-02-17
Last updated
2026-02-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07414537. Inclusion in this directory is not an endorsement.