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| ID | Type | Description | Link |
|---|---|---|---|
| SCI-TBI-2025-00025 | Other Grant/Funding Number | State of Minnesota Office of Higher Education |
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| Name | Class |
|---|---|
| Center for Veterans Research and Education | OTHER |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS with cognitive training | Experimental | Participants will receive 10 sessions of cognitive training concurrent with transcranial direct current stimulation (45 minutes of cognitive training with tDCS applied for first 20 minutes of session; tDCS: 2mA, 30s ramp up/down, anode at F3, cathode at F4). |
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| Sham tDCS with cognitive training | Sham Comparator | Participants will receive 10 sessions of cognitive training concurrent with sham transcranial direct current stimulation (45 minutes of cognitive training with sham tDCS: 2mA current will be ramped down immediately after the initial 30s ramp up period and then at 20 minutes ramped up and down as done at the beginning, anode at F3, cathode at F4). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active tDCS and Cognitive Training Intervention | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Score | 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). | Baseline, 1-week post, & 6-weeks post intervention |
| Electroencephalogram (EEG) - Resting State Theta Band Functional Connectivity | 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. | Baseline, 1-week post, & 6-weeks post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Neurobehavioral Symptom Inventory (NSI) Total Score | A 22-item measure that assesses post-concussive symptoms for those with a TBI. | Baseline, 1-week post, & 6-weeks post intervention |
| Insomnia Severity Index (ISI) Total Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Casey S Gilmore, PhD | Contact | 612-629-7466 | casey.gilmore2@va.gov | |
| Laura Hemmy, PhD | Contact | 612-467-2323 | laura.hemmy@va.gov |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis VA Health Care System | Recruiting | Minneapolis | Minnesota | 55417 | United States |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Sham tDCS and Cognitive Training Intervention | Combination Product | Forty-five minutes of cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning and end of session). |
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A 7-item measure of the severity of nighttime and daytime components of insomnia.
| Baseline, 1-week post, & 6-weeks post intervention |
| Patient Health Questionnaire-8 (PHQ-8) Total Score | An 8-item measure of depressive symptoms. | Baseline, 1-week post, & 6-weeks post intervention |
| Groton Maze Learning Task (GMLT) Completion Time | A computer cognitive test of spatial working memory and error monitoring. | Baseline, 1-week post, & 6-weeks post intervention |
| NIH Toolbox Quality of Life Assessment (NeuroQoL) | Questionnaire to assess quality of life with regard to cognitive, social, emotional, and behavioral abilities. | Baseline, 1-week post, & 6-weeks post intervention |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |