Transcutaneous Auricular Vagus Nerve Stimulation to Improve Upper Extremity Recovery After Traumatic Brain Injury

Part of paid clinical trials in Englewood, Colorado.

Sponsor
Craig Hospital
Study ID
NCT07867015
Status
Not Yet Recruiting

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Conditions

  • Traumatic Brain Injury
  • Upper Extremity

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • taVNS + FTP — DEVICE
    Both groups will receive the same structured upper extremity rehabilitation program. Each 60-minute session will include approximately 40 minutes of upper extremity FTP and 10 minutes of functional carryover activities in a real-world or simulated context, with remaining time used for setup, monitoring, and transition. Training will target gross upper extremity movement, bilateral pinch, bilateral grasp, unilateral grasp, complex or unilateral pinch, and finger isolation. Progression may include increased repetitions or speed, resistance, reduced therapist assistance, and varied task contexts using common objects. Participants assigned to active taVNS will perform upper extremity FTP while receiving stimulation through an earbud electrode positioned on the auricular concha. Current intensity will be individually adjusted to a tolerable level. Stimulation may be reduced, paused, or stopped for discomfort or safety concerns.
  • FTP + sham taVNS — OTHER
    Both groups will receive the same structured upper extremity rehabilitation program. Each 60-minute session will include approximately 40 minutes of upper extremity FTP and 10 minutes of functional carryover activities in a real-world or simulated context, with remaining time used for setup, monitoring, and transition. Training will target gross upper extremity movement, bilateral pinch, bilateral grasp, unilateral grasp, complex or unilateral pinch, and finger isolation. Progression may include increased repetitions or speed, resistance, reduced therapist assistance, and varied task contexts using common objects. Participants assigned to sham taVNS will complete the identical rehabilitation schedule and activities using identical device placement at the left auricular concha; however, no active stimulation will be delivered. Device setup and study interactions will otherwise be kept as similar as practical between groups.

Study Details

Upper extremity weakness, impaired coordination, reduced dexterity, and limited arm and hand use may continue after TBI. Repetitive, task-specific rehabilitation may improve function, but recovery can remain incomplete. taVNS is a non-invasive form of electrical stimulation delivered to part of the outer ear. The stimulation is intended to activate nerve pathways involved in learning and brain plasticity while you practice upper extremity tasks. This pilot study will evaluate safety, tolerability, feasibility, and preliminary effects on upper extremity function and cognition. Up to 40 people will take part at Craig Hospital.

Key Dates

First listed
Oct 9, 2026
Start date
Nov 1, 2026
Status verified
Oct 2026
Primary completion
Nov 1, 2027
Completion
May 1, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: taVNS + FTP
    Participants assigned to active taVNS will perform upper extremity FTP while receiving stimulation through an earbud electrode positioned on the auricular concha. Current intensity will be individually adjusted to a tolerable level. Stimulation may be reduced, paused, or stopped for discomfort or safety concerns.
  • Sham Comparator: sham taVNS + FTP
    Participants assigned to sham taVNS will complete the identical rehabilitation schedule and activities using identical device placement at the left auricular concha; however, no active stimulation will be delivered. Device setup and study interactions will otherwise be kept as similar as practical between groups.

Primary Outcome Measure

Safety of intervention [ Time Frame: From enrollment to the end of treatment at 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Craig HospitalEnglewoodColorado80113
Candy Tefertiller, PT, DPT, PhD, NCS
[email protected]
303-789-8251
Mackenzie Peckham, MPH
[email protected]
303-789-8543
Candy Tefertiller, PT, DPT, PhD, NCS (PRINCIPAL_INVESTIGATOR)

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By research site
Craig Hospital· Englewood, CO

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