tDCS and Cognitive Training in Active Duty Service Members With Mild TBI: A Pilot Study (NCT04925453) | Clinical Trial Compass
CompletedNot Applicable
tDCS and Cognitive Training in Active Duty Service Members With Mild TBI: A Pilot Study
United States56 participantsStarted 2021-01-19
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 fr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combined transcranial direct current stimulation (tDCS) — a form of mild electrical brain stimulation — with cognitive training specifically for active duty service members with mild TBI; now that it's completed, has my doctor seen any of the results, and what do they suggest about whether this combination approach might be worth considering for my situation?
2The trial measured attention and processing speed using tests like the Symbol Digit Modalities Test and EEG brain activity, so can my doctor tell me whether my own cognitive profile — particularly my attention and memory difficulties — looks similar to what this study was targeting, and whether that matters for my treatment options?
3Since this was a pilot study labeled 'Phase NA,' meaning it was likely focused on feasibility and early signals rather than proving the treatment works, how should I weigh that when comparing this approach to standard rehabilitation options already available to me?
4The trial was specifically designed for active duty service members — would my doctor consider my current duty status or military context relevant to whether the findings from this study apply to my care, especially if I'm now a veteran or civilian patient?
5Optional MRI without contrast was included as an outcome measure; given my history of mild TBI, should I be discussing brain imaging as part of my current evaluation regardless of this trial, and what would my doctor be looking for?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Symbol Digit Modalities Test (SDMT)
Timeframe: Change from Baseline SDMT at 1 week after the intervention.
2
Symbol Digit Modalities Test (SDMT)
Timeframe: Change from Baseline SDMT at 6 weeks after the intervention.
3
Symbol Digit Modalities Test (SDMT)
Timeframe: Change from 1 week post-intervention SDMT at 6 weeks after the intervention.