Noninvasive Vagal Nerve Stimulation and Cognitive Rehabilitation
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Traumatic Brain Injury
In brief
The purpose of this study is to examine the feasibility and preliminary efficacy of using transcutaneous auricular vagus nerve stimulation (tVNS) to enhance cognitive recovery in patients with mild-moderate traumatic brain injury (TBI).
Key facts
- Study ID
- NCT06589362
- Run by
- Shirley Ryan AbilityLab
- People needed
- 60
- Starts
- 2024-09-07
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2025-03-25
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- In inpatient rehabilitation due to recent Traumatic Brain Injury, ages 18-65 years.
- Ability to independently use a keyboard. Able to understand and communicate in English (according to clinical judgment). Able to independently provide consent to participate. Orientation to place, time, and situation (two consecutive scores of 25 or more on the Orientation Log(O-Log)40. This scale is routinely administered during acute rehabilitation stay.
You may not qualify if…
- Acute medical issues requiring close physician or nursing monitoring. Bioelectrical implants, including pacemakers. Pregnancy or persons who are lactating. Significant gross or fine motor weakness. Significant, ongoing communication or comprehension impairments (such as aphasia) that would affect an individual's ability to complete the required assessments.
- Acute agitation or behavioral issues, as defined by a last Agitated Behavior Scale Score greater than 21 (routinely administered during acute rehabilitation stay, that would affect an individual's ability to participate in the required assessments.
- Severely impaired memory retention (Score lower than 3 in the 3 Word Delayed Recall test, routinely administered during acute rehabilitation stay.
- Diagnosis of depression. Active substance abuse.
Where it is running
- Shirley Ryan AbilityLab — Chicago, Illinois, United States (enrolling)
Full record on ClinicalTrials.gov
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