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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| Uniformed Services University of the Health Sciences | FED |
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This is a preliminary, prospective interventional study to investigate the feasibility of using transcutaneous alternating current stimulation (TACS) after a traumatic brain injury (TBI) to improve cognitive function and decision-making.
All participants engaged in the study will participate once weekly for six weeks at Hennepin Healthcare Systems, Inc. (HHS). Each participant will be randomized into the block design of sham or tACS during the first three appointments or the last three appointments. While participating, both the tACS will be applied in accordance with the manufacturer's suggested use. Participants will complete computer-based tasks, while taking part in either the sham or tACS stimulation. The study is investigating the use of neuromodulation after Traumatic Brain Injury (TBI) for improved cognitive function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham | Sham Comparator | No stimulation |
|
| Stimulation | Active Comparator | Stimulation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External non-invasive stimulation | Combination Product | The participants are randomized into the block design of sham or tACS during the first three appointments or the last three appointments. Eye tracking will be used to test the predominant focus of decisions during the gaze phase on costs or difficulty levels during the COGED. The study is investigating the use of neuromodulation after TBI for improved cognitive function. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of using non-invasive stimulation to improve Cognitive Flexibility after TBI | Using non-invasive transcranial alternating current stimulation, it will be determined if this study is feasible for improving cognitive recovery after mild to moderate brain injury. To determine the sum total of completion rate of study procedures. | 3 years |
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Inclusion Criteria:
Healthy participants:
Exclusion Criteria:
Healthy subject exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Darrow, MD | Contact | 612-873-7481 | Darro015@umn.edu | |
| David Darrow, MD | Contact | darro015@umn.edu |
| Name | Affiliation | Role |
|---|---|---|
| David Darrow, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin County Medical Center | Recruiting | Minneapolis | Minnesota | 55415 | 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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Block design
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Participants are blinded to stimulation versus no stimulation.
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| COGED | Behavioral | The COGED task consists of the classic N-back task of working memory-based decision making, followed by a valuation phase. The N-back phase of the task allows calculation of cognitive performance of a working memory task. During valuation, participants receive titrating offers of differing amounts of money to perform different difficulty levels of the N-back. The result is an effort discounting curve used to measure the individual effort cost. Effort discounting curves show the perceived cognitive effort required to complete each level of the task relative to another (typically the 1-back). |
|
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |