Minneapolis VA Health Care System
Minneapolis, Minnesota, 55417, United States
Location status: Recruiting
Location contact
Casey S Gilmore, PhD
CONTACT
Casey S Gilmore, PhD
PRINCIPAL_INVESTIGATOR
Laura Hemmy, PhD
CONTACT
NCT Number: NCT07332299
The goal of this clinical trial is to learn if combining brain stimulation with cognitive training can improve thinking skills in older adults who have had a traumatic brain injury (TBI).
The main questions are:
* Does transcranial direct current stimulation (tDCS) make cognitive training more effective for improving attention, memory, and decision-making? * Is this type of home-based program feasible and acceptable for older adults with TBI?
Researchers will compare two groups: one group will receive active tDCS during cognitive training, and the other group will receive sham (placebo) tDCS during cognitive training.
Participants will:
* Complete computer-based cognitive training exercises (BrainHQ) to practice attention, memory, and decision-making. * Receive either active or sham tDCS during training sessions. * Complete assessments before and after the program to measure changes in thinking and daily functioning.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Minneapolis, Minnesota, 55417, United States
Location status: Recruiting
Casey S Gilmore, PhD
CONTACT
Casey S Gilmore, PhD
PRINCIPAL_INVESTIGATOR
Laura Hemmy, PhD
CONTACT
Traumatic brain injury (TBI) is a major public health issue among older adults. Each year, thousands of seniors sustain TBIs, most often from falls. Even when the injury is classified as "mild," it can lead to long-term problems with memory, attention, decision-making, and self-control. These difficulties can make it harder to live independently, maintain social relationships, and manage everyday responsibilities. Older adults with a history of TBI are also at greater risk of experiencing faster cognitive decline as they age. Unfortunately, there are few effective treatments available to improve thinking skills in this group.
This study is designed to test a new approach that combines **computer-based cognitive training** with **transcranial direct current stimulation (tDCS)**, a safe, non-invasive form of brain stimulation. The goal is to determine whether this combined treatment can improve attention, memory, and decision-making in older adults with TBI, and whether the program is practical for participants to complete at home with remote supervision.
About the Interventions
Study Design
This is a randomized controlled trial. All participants will complete the same set of cognitive training exercises, but they will be randomly assigned to one of two groups:
This design allows researchers to determine whether adding tDCS produces greater improvements than cognitive training alone.
Study Procedures
Participants will:
Key Questions
The study is designed to answer three main questions:
Importance of the Study
Older adults with TBI are at particularly high risk for poor outcomes, but they are often underrepresented in research. This study is innovative in several ways:
Potential Impact
If successful, this research could provide the foundation for a new, effective treatment option for older adults with TBI. The intervention is low-risk, non-invasive, and can be delivered in the home setting with minimal equipment. It could help participants improve cognitive functioning, maintain independence longer, and enhance quality of life. At a broader level, the study could reduce the burden of TBI-related cognitive decline on families, caregivers, and healthcare systems.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Forty-five minutes of cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for the first 20 minutes of the session.
Other names: tDCS
Forty-five minutes of cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning and end of session).
Other names: sham tDCS
Time frame: Baseline, 1-week post, & 6-weeks post intervention
The RBANS is a commonly-used, psychometrically-sound measure of cognitive function across the lifespan. The primary outcome measure is the Total Scale score, which is a standard score (mean 100, SD 15) across five cognitive domains (Immediate/Delayed Memory, Visuospatial, Attention, Language).
Time frame: Baseline, 1-week post, & 6-weeks post intervention
Resting State EEG will be collected to assess neural dynamics or functional connectivity and spectral power of delta,theta, alpha, beta, and gamma frequency bands. The primary outcome measure will be change in prefrontal-parietal functional connectivity in the theta frequency band.
Time frame: Baseline, 1-week post, & 6-weeks post intervention
A 22-item measure that assesses post-concussive symptoms for those with a TBI.
Time frame: Baseline, 1-week post, & 6-weeks post intervention
A 7-item measure of the severity of nighttime and daytime components of insomnia.
Time frame: Baseline, 1-week post, & 6-weeks post intervention
An 8-item measure of depressive symptoms.
Time frame: Baseline, 1-week post, & 6-weeks post intervention
A computer cognitive test of spatial working memory and error monitoring.
Time frame: Baseline, 1-week post, & 6-weeks post intervention
Questionnaire to assess quality of life with regard to cognitive, social, emotional, and behavioral abilities.
Contact information is provided by the study sponsor or research team.
Casey S Gilmore, PhD
CONTACT
Laura Hemmy, PhD
CONTACT
Minneapolis Veterans Affairs Medical Center
Fed
Acronym: ReSTART
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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