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

NCT07867015 | Not Yet Recruiting FDA Device

• 1 other identifier: 2904
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury; Upper Extremity

Keywords

Transcutaneous auricular vagus nerve stimulation; Functional task-specific practice; Traumatic brain injury; Upper extremity function

Outcome Measures

Primary Outcomes (7)

• Safety of intervention

  Number, type, severity, study-relatedness, action taken, and outcome of adverse events.

  From enrollment to the end of treatment at 4 weeks

• Tolerability of intervention

  Stimulation-related discomfort using a 0-10 Numeric Rating Scale during sessions; reasons for pauses or discontinuation.

  From enrollment to end of treatment at 4 weeks

• Feasibility of intervention

  Recruitment, retention, session attendance, proportion completing at least 80% of sessions, dropout attributable to taVNS, and protocol deviations.

  From enrollment to end of treatment at 4 weeks

• Fugl-Meyer Assessment Upper Extremity (FMA-UE)

  A standardized clinical assessment used to evaluate motor impairment and recovery of the arm and hand following neurological injury. The upper extremity portion assesses movement, coordination, reflex activity, and hand function. During the assessment, participants are asked to perform a series of arm, wrist, and hand movements while a trained examiner observes and scores performance. Tasks include movements such as shoulder elevation, elbow flexion and extension, wrist motion, grasping objects, and finger movements. Scores are based on the participant's ability to successfully complete each movement. The assessment is commonly used in rehabilitation research to quantify upper extremity motor impairment and recovery. Administration typically requires approximately 20-30 minutes.

  Baseline and 4 weeks

• Action Research Arm Test (ARAT)

  A standardized assessment of upper extremity functional ability. It evaluates a participant's capacity to perform tasks involving grasp, grip, pinch, and gross arm movement. Participants are asked to manipulate a variety of commonly used objects of different sizes, shapes, and weights, such as blocks, balls, and tubes. Tasks include picking up, moving, and placing objects as well as performing gross reaching movements. Performance is scored according to the participant's ability to complete each task within specified time limits. The ARAT provides an objective measure of upper extremity functional performance and is widely used in neurological rehabilitation research. Administration typically requires approximately 10-20 minutes.

  Baseline and 4 weeks

• Box and Block Test (BBT)

  A standardized measure of manual dexterity and gross hand function. During the test, participants sit in front of a box divided into two compartments containing small wooden blocks. Participants are instructed to move as many blocks as possible, one at a time, from one compartment to the other using one hand during a 60-second period. The test is completed separately for each hand. The primary outcome is the number of blocks successfully transferred within the allotted time. The BBT is commonly used to assess hand dexterity and upper extremity function in individuals with neurological and musculoskeletal conditions. Administration typically requires approximately 5 minutes.

  Baseline and 4 weeks

• Patient Global Impression of Change (PGIC)

  A patient-reported outcome measure used to assess an individual's perceived change in upper extremity function following treatment. At the post-treatment assessment, participants will be asked to rate how their arm and hand function has changed since the start of the study using a 7-point scale. Response options range from "very much worse" to "very much improved." The PGIC captures the participant's overall perception of meaningful functional change and complements objective clinical measures of upper extremity performance. The assessment consists of a single question, requires approximately 1 minute to complete, and poses minimal risk to participants.

  End of treatment at 4 weeks

Secondary Outcomes (5)

• Brief Assessment of Cognition and Treatment (BTACT)

  Baseline and 4 weeks

• Mini-Mental State Examination (MMSE)

  Baseline and 4 weeks

• Functional near-infrared spectroscopy (fNIRS)

  Baseline and 4 weeks

• Brief Symptom Inventory-18 (BSI-18)

  Baseline and 4 weeks

• DSM-5 Level 1 Cross-Cutting Symptom Measure (Adult)

  Baseline and 4 weeks

Study Arms (2)

taVNS + FTP

EXPERIMENTAL

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.

Device: taVNS + FTP

sham taVNS + FTP

SHAM COMPARATOR

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.

Other: FTP + sham taVNS

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.

taVNS + FTP

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.

sham taVNS + FTP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• History of TBI requiring inpatient rehabilitation, with resulting upper extremity impairment in at least one limb
• Passive range of motion within functional limits at the wrists, shoulders, and elbows.
• Able to attend on-site training at Craig Hospital three times per week for four weeks.
• No complicating physical or cognitive condition, as determined by the physician or study investigator, that would preclude safe use of taVNS.
• If taking prescribed antispasticity medication, dose stable for at least four weeks before study procedures.
• Able to provide informed consent.

You may not qualify if:

• Recent fracture or contracture that could interfere with the intervention.
• Botulinum toxin injections to the upper extremity or hand within the previous three months.
• Pregnant, planning pregnancy, or breastfeeding.
• Concurrent participation in another drug or device trial that may interfere with this study.
• Implanted pacemaker, spinal cord stimulator, ventriculoperitoneal shunt, deep brain stimulator, or intrathecal pump.
• Any condition or circumstance that, in the investigator's judgment, makes participation unsafe or inappropriate.

Sponsors & Collaborators

• Craig Hospital: lead

Study Sites (1)

Craig Hospital

Englewood, Colorado, 80113, United States

Location

Related Publications (12)

• Stephens J, Hays K, Winden H, Busch B, Tefertiller C. Assessing Task-Dependent Neurophysiology During Virtual Reality Treadmill Training in Adults With Traumatic Brain Injury: A Functional Near-Infrared Spectroscopy Feasibility Study. J Head Trauma Rehabil. 2026 Jan-Feb 01;41(1):E59-E67. doi: 10.1097/HTR.0000000000001057. Epub 2025 Dec 29.

  PMID: 40203004 BACKGROUND

• DiBlasio CA, Novack TA, Cook EW 3rd, Dams-O'Connor K, Kennedy RE. Convergent Validity of In-Person Assessment of Inpatients With Traumatic Brain Injury Using the Brief Test of Adult Cognition by Telephone (BTACT). J Head Trauma Rehabil. 2021 Jul-Aug 01;36(4):E226-E232. doi: 10.1097/HTR.0000000000000677.

  PMID: 33656489 BACKGROUND

• Wang L, Gao F, Dai Y, Wang Z, Liang F, Wu J, Wang M, Wang L. Transcutaneous auricular vagus nerve stimulation on upper limb motor function with stroke: a functional near-infrared spectroscopy pilot study. Front Neurosci. 2023 Nov 21;17:1297887. doi: 10.3389/fnins.2023.1297887. eCollection 2023.

  PMID: 38075278 BACKGROUND

• Yan L, Qian Y, Li H. Transcutaneous Vagus Nerve Stimulation Combined with Rehabilitation Training in the Intervention of Upper Limb Movement Disorders After Stroke: A Systematic Review. Neuropsychiatr Dis Treat. 2022 Sep 16;18:2095-2106. doi: 10.2147/NDT.S376399. eCollection 2022.

  PMID: 36147448 BACKGROUND

• Wu D, Ma J, Zhang L, Wang S, Tan B, Jia G. Effect and Safety of Transcutaneous Auricular Vagus Nerve Stimulation on Recovery of Upper Limb Motor Function in Subacute Ischemic Stroke Patients: A Randomized Pilot Study. Neural Plast. 2020 Aug 1;2020:8841752. doi: 10.1155/2020/8841752. eCollection 2020.

  PMID: 32802039 BACKGROUND

• Frangos E, Ellrich J, Komisaruk BR. Non-invasive Access to the Vagus Nerve Central Projections via Electrical Stimulation of the External Ear: fMRI Evidence in Humans. Brain Stimul. 2015 May-Jun;8(3):624-36. doi: 10.1016/j.brs.2014.11.018. Epub 2014 Dec 6.

  PMID: 25573069 BACKGROUND

• Yakunina N, Kim SS, Nam EC. Optimization of Transcutaneous Vagus Nerve Stimulation Using Functional MRI. Neuromodulation. 2017 Apr;20(3):290-300. doi: 10.1111/ner.12541. Epub 2016 Nov 29.

  PMID: 27898202 BACKGROUND

• Redgrave JN, Moore L, Oyekunle T, Ebrahim M, Falidas K, Snowdon N, Ali A, Majid A. Transcutaneous Auricular Vagus Nerve Stimulation with Concurrent Upper Limb Repetitive Task Practice for Poststroke Motor Recovery: A Pilot Study. J Stroke Cerebrovasc Dis. 2018 Jul;27(7):1998-2005. doi: 10.1016/j.jstrokecerebrovasdis.2018.02.056. Epub 2018 Mar 23.

  PMID: 29580658 BACKGROUND

• Redgrave J, Day D, Leung H, Laud PJ, Ali A, Lindert R, Majid A. Safety and tolerability of Transcutaneous Vagus Nerve stimulation in humans; a systematic review. Brain Stimul. 2018 Nov-Dec;11(6):1225-1238. doi: 10.1016/j.brs.2018.08.010. Epub 2018 Aug 23.

  PMID: 30217648 BACKGROUND

• Dawson J, Liu CY, Francisco GE, Cramer SC, Wolf SL, Dixit A, Alexander J, Ali R, Brown BL, Feng W, DeMark L, Hochberg LR, Kautz SA, Majid A, O'Dell MW, Pierce D, Prudente CN, Redgrave J, Turner DL, Engineer ND, Kimberley TJ. Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial. Lancet. 2021 Apr 24;397(10284):1545-1553. doi: 10.1016/S0140-6736(21)00475-X.

  PMID: 33894832 BACKGROUND

• Bayona NA, Bitensky J, Salter K, Teasell R. The role of task-specific training in rehabilitation therapies. Top Stroke Rehabil. 2005 Summer;12(3):58-65. doi: 10.1310/BQM5-6YGB-MVJ5-WVCR.

  PMID: 16110428 BACKGROUND

• Subramanian SK, Fountain MK, Hood AF, Verduzco-Gutierrez M. Upper Limb Motor Improvement after Traumatic Brain Injury: Systematic Review of Interventions. Neurorehabil Neural Repair. 2022 Jan;36(1):17-37. doi: 10.1177/15459683211056662. Epub 2021 Nov 12.

  PMID: 34766518 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Candy Tefertiller, PT, DPT, PhD, NCS

CONTACT

303-789-8251; ctefertiller@craighospital.org

Mackenzie Peckham, MPH

CONTACT

303-789-8543; mpeckham@craighospital.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-site, pilot, randomized, sham-controlled, assessor-masked trial. Up to 40 participants will be randomized in a 2:1 ratio to active taVNS plus FTP or sham taVNS plus FTP.

Study Record Dates

• First Submitted: October 2, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: October 9, 2026

Record last verified: 2026-10

Locations

US (1)