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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20-75
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Cognitive training

    Other intervention

    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.

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: tDCSActive comparator 2 interventions
Group B: Sham tDCSSham comparator 2 interventions

Trial outcomes

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.

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

Secondary outcomes

1

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)
2

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)
3

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)

Other outcomes

Sponsors and contacts

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