Brain Injuries, Cognition, Stress Disorders, Post-Traumatic
Conditions
Keywords
Cognitive impairment, Rehabilitation, Neuromodulation
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.
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.
Interventions
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 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All study staff and participants will be blinded to study condition.
Intervention model description
Double blinded randomized controlled trial of the device transcranial direct current stimulation (tDCS)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NIH Toolbox Fluid Composite score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difficulties in Emotion Regulation Scale (DERS) | 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. |
| Glasgow Coma Scale-Extended (GOSE) | 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). |
| Quality of Life after Brain Injury Overall Scale (QOLIBRI-OS) | 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. |
Countries
United States
Contacts
CONTACTKelly L Sloane, PhD
PRINCIPAL_INVESTIGATORKelly L Sloane, PhD
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Outcome results
None listed