Clinical trial NCT04925453: tDCS and Cognitive Training in Active Duty Service Members With Mild TBI: A Pilot Study
Official title: Transcranial Direct Current Stimulation (tDCS) and Cognitive Training to Improve Concentration and Working Memory in Active Duty Service Members Following Mild Traumatic Brain Injury (mTBI): A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Concussion
Brain Trauma
Attention Concentration Difficulty
Brain Injuries
Brain Injuries, Traumatic
Neurocognitive Dysfunction
Attention Impaired
Memory Impairment
Mild Traumatic Brain Injury
Mild Cognitive Impairment
Keywords: military health
brain stimulation
cognitive training
cognitive rehabilitation
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
Collaborators: name: The Defense and Veterans Brain Injury Center
First posted: 2021-06-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a double-blind, randomized, placebo (sham) controlled pilot study.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* (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).

Exclusion Criteria:

* (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.

Primary outcomes:
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: Change from Baseline SDMT at 1 week after the intervention.
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: Change from Baseline SDMT at 6 weeks after the intervention.
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: Change from 1 week post-intervention SDMT at 6 weeks after the intervention.
measure: Neuropsychological Assessment Battery (NAB) Attention Module
timeFrame: Change from Baseline NAB Attention Module at 1 week after the intervention.
measure: Neuropsychological Assessment Battery (NAB) Attention Module
timeFrame: Change from Baseline NAB Attention Module at 6 weeks after the intervention.
measure: Neuropsychological Assessment Battery (NAB) Attention Module
timeFrame: Change from 1 week post-intervention NAB Attention Module at 6 weeks after the intervention.
measure: Electroencephalogram (EEG)
timeFrame: Change from Baseline EEG at 1 week after the intervention.
measure: Electroencephalogram (EEG)
timeFrame: Change from Baseline EEG at 6 weeks after the intervention.
measure: Electroencephalogram (EEG)
timeFrame: Change from 1 week post-intervention EEG at 6 weeks after the intervention.
measure: Neurobehavioral Symptom Inventory (NSI)
timeFrame: Change from Baseline NSI at 1 week after the intervention.
measure: Neurobehavioral Symptom Inventory (NSI)
timeFrame: Change from Baseline NSI at 6 weeks after the intervention.
measure: Neurobehavioral Symptom Inventory (NSI)
timeFrame: Change from 1 week post-intervention NSI at 6 weeks after the intervention.
measure: Magnetic Resonance Imaging (MRI) w/out contrast (optional)
timeFrame: Change from Baseline MRI at 1 week after the intervention.
Secondary outcomes:
measure: NIH Toolbox Quality of Life Assessment (NeuroQoL)
timeFrame: Change from Baseline NeuroQoL at 1 week after the intervention.
measure: NIH Toolbox Quality of Life Assessment (NeuroQoL)
timeFrame: Change from Baseline NeuroQoL at 6 weeks after the intervention.
measure: NIH Toolbox Quality of Life Assessment (NeuroQoL)
timeFrame: Change from 1 week post-intervention NeuroQoL at 6 weeks after the intervention.
measure: Insomnia Severity Index (ISI)
timeFrame: Change from Baseline ISI at 1 week after the intervention.
measure: Insomnia Severity Index (ISI)
timeFrame: Change from Baseline ISI at 6 weeks after the intervention.
measure: Insomnia Severity Index (ISI)
timeFrame: Change from 1 week post-intervention ISI at 6 weeks after the intervention.
measure: Fusion Task
timeFrame: Change from Baseline Fusion task at 1 week after the intervention.
measure: Fusion Task
timeFrame: Change from Baseline Fusion task at 6 weeks after the intervention.
measure: Fusion Task
timeFrame: Change from 1 week post-intervention Fusion task at 6 weeks after the intervention.
measure: tDCS Symptom Rating Questionnaire (SRQ)
timeFrame: Change from pre-intervention SRQ at post-intervention.
measure: BrainHQ Task Load Index (TLX)
timeFrame: Immediately after the intervention.
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
Study officials:
affiliation: United States Naval Medical Center, San Diego
name: Lars D Hungerford, PhD
role: PRINCIPAL_INVESTIGATOR
References: