tDCS and Cognitive Training in Active Duty Service Members With Mild TBI: A Pilot Study
- Conditions
- Attention Concentration DifficultyBrain Injuries, TraumaticMemory ImpairmentMild Cognitive ImpairmentBrain ConcussionBrain TraumaBrain InjuriesAttention ImpairedNeurocognitive DysfunctionMild Traumatic Brain Injury
- Interventions
- Combination Product: sham tDCS and cognitive training interventionCombination Product: active tDCS and cognitive training intervention
- Registration Number
- NCT04925453
- Lead Sponsor
- United States Naval Medical Center, San Diego
- Brief Summary
The proposed study will evaluate a new approach to cognitive rehabilitation of mild traumatic brain injury (mTBI) using a brain stimulation technique called transcranial direct current stimulation (tDCS). Specifically, we will investigate how tDCS combined with cognitive training improves deficits to attention and working memory in Active Duty Service Members with a history of mild traumatic brain injury (TBI). Measures of attention-related brain activity, neurocognitive assessments, and self-reported clinical outcomes will be used to determine effects of tDCS vs. sham tDCS when paired with a cognitive training intervention. By doing this study, we hope to find a reliable, noninvasive, and efficient method of treating mild TBI cognitive symptoms.
- Detailed Description
Objectives: The proposed study will evaluate a new approach to cognitive rehabilitation of mild traumatic brain injury (mTBI) using a brain stimulation technique called transcranial direct current stimulation (tDCS). Specifically, we will investigate how tDCS combined with cognitive training improves deficits to attention and working memory in Active Duty Service Members with a history of mTBI. Measures of attention-related brain activity, neurocognitive assessments, and self-reported clinical outcomes will be used to determine effects of tDCS vs. sham tDCS when paired with a cognitive training intervention. By doing this study, we hope to find a reliable, noninvasive, and efficient method of treating mild TBI cognitive symptoms.
Research Plan and Methods: This is a double-blind, randomized, placebo (sham) controlled pilot study. We will recruit 60 Active Duty Service Members who are receiving outpatient services at Naval Medical Center San Diego, with a history of mTBI and reported neurocognitive symptoms related to attention, working memory, and related cognitive processes. Intake will involve a full pre-assessment of symptoms, neurocognitive performance, and an optional MRI scan. Participants will be randomized to either active or sham tDCS. Training/tDCS sessions will occur daily over five consecutive days. Random permuted blocks will be used to ensure exactly equal treatment numbers at certain equally spaced points in the sequence of patient assignment. Post-intervention assessment will include another assessment of symptoms, neurocognitive performance, and an optional MRI scan. Participants will complete assessments of symptoms and neurocognitive performance six-weeks following the post-intervention assessment.
Clinical Relevance to TBICoE/Navy Medicine: Aspects of this study will provide insight into a major research gap highlighted in the mission of the Defense and Veterans Brain Injury Center, specifically in identifying/ developing innovative treatments/interventions which promote patient recovery and/or mitigate symptoms after mTBI. Novel, well-tolerated, neuroplasticity-based interventions that can improve attention, concentration, and working memory by targeting the underlying neural dysfunction are needed to improve outcomes and quality of life for Active Duty Service Members affected by neurocognitive weakness and dysfunction following mTBI. If tDCS proves successful in reducing TBI-related symptoms, improving cognition, or enhancing functional recovery, this non-invasive intervention could be implemented within various DoD and VA settings, enhancing recovery, improving quality of life, and bolstering occupational performance.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- (1) Have a remote history mild traumatic brain injury as defined by the VA/DoD clinical practice guidelines(The Management of Concussion/mTBI Working Group, 2016) that is >/= 6 months, and report moderate severity neurocognitive symptoms related to attention, concentration, working memory, or memory based on NSI scores and self-report.
- (2) Are between the ages of 18-55.
- (3) Are stable on any medications for at least 2 weeks at the baseline visit (Visit #1).
- (1) Have a history of seizures or epilepsy.
- (2) Have a history of ECT or cortical energy exposure within the past 12 months, including participation in any other neuromodulation studies.
- (3) Have current stimulant dependence.
- (4) Have a diagnosis of intellectual disability or pervasive developmental disorder (i.e. premorbid IQ less than or equal to 70).
- (5) Have any medical condition or treatment other than mild TBI (e.g. stroke, tumor, HIV, moderate-severe TBI), with significant neurological disorder or insults that, based on the Principal Investigator's judgement, would impact risk.
- (6) Diagnosed with current active psychosis or mania.
- (7) Have metallic cranial plates/screws or implanted device,
- (8) Have eczema on scalp or other scalp lesions or skin disorders that may become irritated by stimulation.
- (9) Pregnant individuals and individuals with ferromagnetic metal in their body that would prohibit them from being safe in the MRI will not be excluded from the overall study, but will be excluded from the optional MRI.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham tDCS sham tDCS and cognitive training intervention For sham stimulation, the electrodes will be placed at the same positions as for active stimulation (F3 and F4). After an initial ramp-up period of 30 seconds, stimulation fades out over a period of 30 seconds. Additionally, at the end of the sham stimulation period, stimulation will fade in over a period of 30 seconds and then end with a final 30 second ramp-down period. Participants will feel the initial itching sensation associated with tDCS and experience the ramp-down period at the end of the sham stimulation period but will receive no active current during the rest of the sham stimulation period. This method of sham stimulation has been shown to be reliable (Gandiga et al., 2006). Before each training session, the impedance of the electrodes will be checked and verified to be ≤15 KOhm. Additionally, the stimulation will be terminated if the impedance of the electrodes is \> 20 KOhm. The current and impedance will be recorded for every session. Active tDCS active tDCS and cognitive training intervention Based on previous studies targeting working memory, focality of current delivery, and comfort and tolerance levels, (Paulo S. Boggio et al., 2006; Hill et al., 2016; Hoy et al., 2013; Teo, Hoy, Daskalakis, \& Fitzgerald, 2011), we will use a 2 mA current administered via two circular carbon rubber core electrodes in saline-soaked surface sponges (25 cm2), placed in a neoprene headcap with marked locations based on the 10-10 EEG system. The anodal stimulating electrode will be at location F3, over left dorsolateral prefrontal cortex (DLPFC) and the cathodal electrode at location F4, over right DLPFC. Two reference electrodes, CMS and DRL, will be attached to the EarClip and applied to the earlobe with conductive gel. Before each training session, the impedance of the electrodes will be checked and verified to be ≤15 KOhm. Additionally, the stimulation will be terminated if the impedance of the electrodes is \> 20 KOhm. The current and impedance will be recorded for every session.
- Primary Outcome Measures
Name Time Method Neurobehavioral Symptom Inventory (NSI) Change from 1 week post-intervention NSI at 6 weeks after the intervention. A measure of common post-concussive symptoms rated on a 5-point Likert scale (0-4); with low scores corresponding to mild or no incidence of symptoms and high scores corresponding to more severe incidence of symptoms.
Magnetic Resonance Imaging (MRI) w/out contrast (optional) Change from Baseline MRI at 1 week after the intervention. Medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in your body. Mean white matter and CSF signals across time are calculated for each participant. Additionally, time courses for regions of interest are also extracted.
Symbol Digit Modalities Test (SDMT) Change from 1 week post-intervention SDMT at 6 weeks after the intervention. Standardized neuropsychological assessment measure of visual attention and working memory
Neuropsychological Assessment Battery (NAB) Attention Module Change from 1 week post-intervention NAB Attention Module at 6 weeks after the intervention. Standardized neuropsychological assessment consisting of 4 subtests to assess visual and auditory attention, working memory, and scanning.
Electroencephalogram (EEG) Change from 1 week post-intervention EEG at 6 weeks after the intervention. EEG will be collected to assess neural dynamics during rest and during performance of generalization tasks. The neural dynamics to be assessed include functional connectivity, mean ERP amplitude, and spectral power of delta, theta, alpha, beta, and gamma frequency bands.
- Secondary Outcome Measures
Name Time Method BrainHQ Task Load Index (TLX) Immediately after the intervention. Subjective workload assessment of level of effort, mental demand, frustration, and performance during cognitive training, rated on a 10-point Likert scale (1-10); with low scores corresponding to less effort or mental demand and high scores corresponding to more effort or mental demand.
Insomnia Severity Index (ISI) Change from 1 week post-intervention ISI at 6 weeks after the intervention. Measure of insomnia severity rated on a 5-point Likert scale (0-4); with low scores corresponding to mild or no incidence of insomnia and high scores corresponding to more severe incidences of insomnia.
Fusion Task Change from 1 week post-intervention Fusion task at 6 weeks after the intervention. Multi-modal assessment of brain function including EEG and eye tracking. The EEG measures to be assessed include functional connectivity, mean ERP amplitude, and spectral power of delta, theta, alpha, beta, and gamma frequency bands. Other outcome measures to be assessed include saccadic response time latency, saccadic response time consistency, manual response time latency, manual response time consistency, and 1-back total score.
NIH Toolbox Quality of Life Assessment (NeuroQoL) Change from 1 week post-intervention NeuroQoL at 6 weeks after the intervention. Questionnaire to assess quality of life with regard to cognitive, social, emotional, and behavioral abilities rated on a 5-point Likert scale (1-5); with low scores corresponding to mild to no impairment in these abilities and high scores corresponding to more severe impairment in these abilities.
tDCS Symptom Rating Questionnaire (SRQ) Change from pre-intervention SRQ at post-intervention. Questionnaire to assess pre-post tDCS symptom rating, rated on a 4-point Likert scale (0-3); with low scores corresponding to mild or no incidence of symptoms and high scores corresponding to severe incidence of symptoms.
Trial Locations
- Locations (1)
Naval Medical Center San Diego
🇺🇸San Diego, California, United States