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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
46
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.
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.
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States
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.
Time frame: Pre- and post-intervention (immediate and 2 months)
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.
Time frame: 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).
Time frame: 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.
Time frame: Pre- and post-intervention (immediate and 2 months)
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