Noninvasive Vagal Nerve Stimulation and Cognitive Rehabilitation

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Shirley Ryan AbilityLab
Study ID
NCT06589362
Status
Recruiting
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Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcutaneous auricular vagus active nerve stimulation — DEVICE
    In the active stimulation, two electrodes are placed in the cymba conchae of one of the ears, an area thought to be exclusively innervated by the auricular branch of the vagus nerve.
  • Transcutaneous auricular vagus sham nerve stimulation — DEVICE
    In the sham stimulation, the electrodes are placed on the tail of helix, which is free of vagal innervation.

Study Details

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 Dates

Start date
Sep 7, 2024
Status verified
Mar 2025
Primary completion
Jun 30, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Transcutaneous auricular vagus nerve stimulation
    Active vagus nerve stimulation.
  • Sham Comparator: Sham Transcutaneous auricular vagus nerve stimulation
    Sham vagus nerve stimulation.

Primary Outcome Measure

N-Back Computerized Task [ Time Frame: 15 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Shirley Ryan AbilityLabChicagoIllinois60610
Katy Magee, M.H.S. SLP
[email protected]
312-238-6451

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