Status:
RECRUITING
Noninvasive Vagal Nerve Stimulation and Cognitive Rehabilitation
Lead Sponsor:
Shirley Ryan AbilityLab
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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-mo...
Detailed Description
Eligible participants will be invited to two sessions, 2-7 days apart. In each session, either active tVNS or sham stimulation will be administered while the participants are performing tasks of execu...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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.
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
September 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06589362
Start Date
September 7 2024
End Date
August 1 2026
Last Update
March 25 2025
Active Locations (1)
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1
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60610