NCT06589362 Noninvasive Vagal Nerve Stimulation and Cognitive Rehabilitation
| NCT ID | NCT06589362 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shirley Ryan AbilityLab |
| Condition | Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-09-07 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-09-07 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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-moderate traumatic brain injury (TBI).
Eligibility Criteria
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.
Contact & Investigator
Shira Cohen-Zimerman, PhD
PRINCIPAL INVESTIGATOR
Shirley Ryan AbilityLab
Frequently Asked Questions
Who can join the NCT06589362 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06589362 currently recruiting?
Yes, NCT06589362 is actively recruiting participants. Contact the research team at sohenzime@sralab.org for enrollment information.
Where is the NCT06589362 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06589362 clinical trial?
NCT06589362 is sponsored by Shirley Ryan AbilityLab. The principal investigator is Shira Cohen-Zimerman, PhD at Shirley Ryan AbilityLab. The trial plans to enroll 60 participants.