NCT05327829

Stimulating After Recovery From Traumatic Brain Injury

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• TBI (Traumatic Brain Injury)

Interventions

Type	Name	Description
COMBINATION_PRODUCT	External non-invasive stimulation	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.
BEHAVIORAL	COGED	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).

Timeline

• Start date: 2025-03-31
• Primary completion: 2028-01-15
• Completion: 2028-01-15
• First posted: 2022-04-14
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study