tDCS and Cognitive Training in Active Duty Service Members With Mild TBI: A Pilot Study

Launched by UNITED STATES NAVAL MEDICAL CENTER, SAN DIEGO · Jun 7, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help Active Duty Service Members who have experienced mild traumatic brain injuries (mTBI) improve their attention and memory skills. The study combines a brain stimulation technique called transcranial direct current stimulation (tDCS) with cognitive training exercises. Researchers want to see if this combination can lead to better outcomes for those struggling with attention and memory issues related to their past injuries. Participants will undergo assessments to measure their brain activity and cognitive abilities throughout the study.

To be eligible for this trial, participants should be between 18 and 55 years old and have a history of mild traumatic brain injury at least six months prior, along with moderate difficulties in attention or memory. They should also be stable on any medications for at least two weeks before starting the study. Throughout the trial, participants can expect to engage in cognitive training sessions, receive brain stimulation, and complete assessments to track their progress. It’s a safe, noninvasive approach that aims to provide effective support for those facing cognitive challenges after a mild TBI.

Gender

ALL

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.