Using brain stimulation and cognitive training to help service members with mild brain injuries
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
NA · United States Naval Medical Center, San Diego · NCT04925453
This study is testing whether a combination of brain stimulation and cognitive training can help active duty service members with mild brain injuries improve their attention and memory.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | United States Naval Medical Center, San Diego (fed) |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT04925453 on ClinicalTrials.gov |
What this trial studies
This study evaluates a new cognitive rehabilitation approach for mild traumatic brain injury (mTBI) using transcranial direct current stimulation (tDCS) combined with cognitive training. It aims to improve attention and working memory deficits in Active Duty Service Members with a history of mTBI. The study will involve 60 participants who will be randomly assigned to receive either active or sham tDCS alongside cognitive training sessions over five consecutive days. Outcomes will be measured through neurocognitive assessments and self-reported clinical outcomes to determine the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates are Active Duty Service Members aged 18-55 with a history of mild TBI and reported cognitive symptoms related to attention and memory.
Not a fit: Patients with a history of seizures, severe TBI, or other significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a reliable and noninvasive method for improving cognitive symptoms associated with mild TBI in service members.
How similar studies have performed: Other studies have shown promise in using tDCS for cognitive rehabilitation, but this specific approach in military populations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
San Diego, California
- Naval Medical Center San Diego — San Diego, California, United States (RECRUITING)
Study contacts
- Principal investigator: Lars D Hungerford, PhD — United States Naval Medical Center, San Diego
- Study coordinator: Lars D Hungerford, PhD
- Email: lars.d.hungerford.ctr@mail.mil
- Phone: 619.532.5715
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Brain Concussion, Brain Trauma, Attention Concentration Difficulty, Brain Injuries, Brain Injuries, Traumatic, Neurocognitive Dysfunction, Attention Impaired, Memory Impairment