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Traumatic Brain InjurytaVNSNCT07867015

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

A study testing taVNS and FTP in people with Traumatic Brain Injury and Upper Extremity, run by Craig Hospital at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Traumatic Brain Injury, Upper Extremity
What is being tested?
taVNS and FTP
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteUnited States
Study dates
1 Nov 2026to 1 May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Candy Tefertiller, PT, DPT, PhD, NCS contact

303-789-8251

ctefertiller@craighospital.org

Mackenzie Peckham, MPH contact

303-789-8543

mpeckham@craighospital.org

United States1 site

  • Craig Hospital

    Englewood, Colorado, 80113

    Candy Tefertiller, PT, DPT, PhD, NCS, 303-789-8251, ctefertiller@craighospital.org

    Mackenzie Peckham, MPH, 303-789-8543, mpeckham@craighospital.org

Other trials in United States

About this study

Official title: Transcutaneous Auricular Vagus Nerve Stimulation to Improve Upper Extremity Recovery After Traumatic Brain Injury: A Pilot Randomized Sham-Controlled Trial

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.

Read the detailed description

Upper extremity impairments are among the most disabling long-term consequences of traumatic brain injury (TBI). Weakness, impaired motor control, reduced dexterity, spasticity, and limited functional arm and hand use can restrict independence, community participation, and return to meaningful life roles. Functional task-specific practice (FTP) is a task-oriented, activity-based rehabilitation approach that uses repeated practice to improve gross upper extremity movement, isolated finger motion, and pinch and grasp needed for daily activities. Despite rehabilitation, many individuals with moderate-to-severe TBI continue to have substantial upper extremity limitations, supporting the need for strategies that may enhance the effects of rehabilitation.

Vagus nerve stimulation (VNS) activates afferent vagal fibers and downstream brainstem nuclei, including the locus coeruleus and basal forebrain. These systems regulate norepinephrine and acetylcholine release and support cortical excitability, attention, learning, long-term potentiation, and task-dependent plasticity. Implanted VNS paired with upper extremity rehabilitation has improved motor outcomes after stroke, but it requires surgery and ongoing device management.

Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive approach that delivers electrical stimulation through surface electrodes placed on the external ear. Studies in stroke suggest that taVNS paired with upper extremity practice is feasible, generally well tolerated, and may enhance upper extremity recovery and task-related cortical activation. taVNS has not been adequately studied for upper extremity recovery after TBI. Because stroke and TBI may share network-level disruptions relevant to motor and cognitive recovery, a pilot sham-controlled trial is warranted to evaluate safety, feasibility, and preliminary effects in TBI.

The overall objective is to evaluate taVNS paired with upper extremity FTP after TBI. The study will also explore effects on cognition and cortical activation measured with functional near-infrared spectroscopy (fNIRS).

Aim 1: Safety, tolerability, and feasibility Evaluate the safety, tolerability, and feasibility of taVNS paired with upper extremity rehabilitation after TBI. The intervention will be considered feasible if more than 80% of participants complete at least 80% of prescribed sessions, with fewer than 10% withdrawing because of taVNS. Mean stimulation-related discomfort is expected to be 4 or less on a 0-10 Numeric Rating Scale, and fewer than 10% of participants are expected to experience device- or protocol-related adverse events.

Aim 2: Preliminary motor effects Compare changes in upper extremity strength and function between participants receiving active taVNS plus FTP and those receiving sham taVNS plus FTP. Active taVNS is hypothesized to produce greater improvement in Action Research Arm Test (ARAT), Box and Blocks Test, and Fugl-Meyer Assessment upper extremity scores and a more favorable Participant Global Impression of Change (PGIC).

Aim 3: Exploratory cognitive and cortical effects Explore changes in cognitive performance using the Brief Test of Adult Cognition by Telephone (BTACT) and Mini-Mental State Examination (MMSE) and evaluate within-participant differences and between group differences in cortical activation during FTP with and without active taVNS using fNIRS.

Being tested
taVNS, FTP
Keywords
Transcutaneous auricular vagus nerve stimulation, Functional task-specific practice, Traumatic brain injury, Upper extremity function
Medical subject headings
Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • taVNSDevice

    Participants assigned to active taVNS will receive 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.

  • FTPOther

    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.

Study groups in NCT07867015
Study groupRoleWhat they receive
taVNS + FTPExperimentalParticipants 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.
Receives: Device: taVNS; Other: FTP
sham taVNS + FTPSham comparatorParticipants 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.
Receives: Other: FTP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety of intervention

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

    Measured: From enrollment to the end of treatment at 4 weeks

  2. Tolerability of intervention

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

    Measured: From enrollment to end of treatment at 4 weeks

  3. Feasibility of intervention

    Frequency counts and percentages will be used to summarize the number of adverse events, and participant's session completion and dropout rate to assess for safety, feasibility, and adherence.

    Measured: From enrollment to end of treatment at 4 weeks

  4. 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 on a scale of 0-2 based on the participant's ability to successfully complete each movement, and a higher score indicates better performance. The assessment is commonly used in rehabilitation research to quantify upper extremity motor impairment and recovery. Administration typically requires approximately 20-30 minutes.

    Measured: Baseline and 4 weeks

  5. 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.

    Measured: Baseline and 4 weeks

  6. 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.

    Measured: Baseline and 4 weeks

  7. 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", and a higher score indicates greater perceived function. 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.

    Measured: End of treatment at 4 weeks

Secondary outcomes (5)

  1. Brief Assessment of Cognition and Treatment (BTACT)

    A brief cognitive assessment battery designed to evaluate cognitive functioning across multiple domains. The assessment includes measures of episodic memory, working memory, processing speed, reasoning, executive functioning, verbal fluency, and attention. The BTACT can be administered in a relatively short period of time and provides a broad assessment of global cognitive function. The measure will be administered at baseline and post-treatment to assess cognitive status and explore changes in cognitive performance over the course of study participation. Higher scores generally reflect better cognitive functioning.

    Measured: Baseline and 4 weeks

  2. Mini-Mental State Examination (MMSE)

    A widely used cognitive screening instrument that provides a brief assessment of global cognitive functioning. The MMSE evaluates several cognitive domains, including orientation, attention, concentration, immediate and delayed memory, language, and visuospatial abilities. The assessment consists of a series of structured questions and tasks and yields a total score ranging from 0 to 30, with higher scores indicating better cognitive functioning. The MMSE will be administered at baseline and post-treatment to characterize participants' cognitive status and to assess for changes in overall cognitive functioning following the intervention. The MMSE is commonly used in clinical and research settings as a screening measure for cognitive impairment.

    Measured: Baseline and 4 weeks

  3. Functional near-infrared spectroscopy (fNIRS)

    A non-invasive neuroimaging technique that measures changes in cerebral blood oxygenation associated with cortical brain activity. During study assessments, participants will wear a lightweight fNIRS cap containing near-infrared light sources and detectors positioned over specific regions of the scalp. The fNIRS system continuously records changes in oxygenated hemoglobin (HbO), deoxygenated hemoglobin (HbR), and total hemoglobin (HbT) while participants perform FPT. The primary fNIRS-derived outcomes include changes in oxygenated, deoxygenated, and total hemoglobin concentrations within targeted cortical regions during FTP conditions. These measures provide information regarding cortical activation patterns and neurophysiological responses associated with upper extremity task performance and rehabilitation. fNIRS data collection typically occurs concurrently with task performance and is expected to last approximately 20-30 minutes. The procedure is associated with minimal risk.

    Measured: Baseline and 4 weeks

  4. Brief Symptom Inventory-18 (BSI-18)

    A brief self-report questionnaire used to screen for psychological distress and psychiatric symptoms. The measure consists of 18 items that assess the degree to which participants have been bothered by various symptoms during the past seven days. Items are rated on a 5-point Likert scale ranging from 0 ("not at all") to 4 ("extremely"). The BSI-18 yields a Global Severity Index (GSI) as an overall measure of psychological distress, as well as three symptom subscales: Somatization, Depression, and Anxiety. Higher scores indicate greater psychological symptom burden. A higher score indicates greater distress and symptoms. The BSI-18 will be used to characterize participants' emotional and psychological functioning and to monitor symptoms that may influence rehabilitation participation and outcomes.

    Measured: Baseline and 4 weeks

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

    A brief self-report screening instrument developed by the American Psychiatric Association to assess psychiatric symptoms across multiple mental health domains. The measure evaluates symptoms experienced during the previous two weeks across domains including depression, anger, mania, anxiety, somatic symptoms, suicidal ideation, psychosis, sleep problems, memory concerns, repetitive thoughts and behaviors, dissociation, personality functioning, and substance use. Responses are provided on a 5-point scale where a higher score reflects greater symptom frequency or severity. The measure is intended to identify clinically relevant symptoms that may warrant further evaluation and provides a broad assessment of mental health symptoms. The DSM-5 Cross-Cutting Symptom Measure will be used to characterize participants' psychiatric symptom profiles and identify factors that may influence study participation, treatment response, or rehabilitation outcomes.

    Measured: Baseline and 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion1 Nov 2027 (estimated)
  4. Study completion1 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07867015
Sponsor's protocol ID
2904
Acronym
taVNS
Status last verified
Oct 2026
First submitted
2 Oct 2026
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 40203004

  • 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.

    PubMed 33656489

  • 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.

    PubMed 38075278

  • 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.

    PubMed 36147448

  • 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.

    PubMed 32802039

  • 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.

    PubMed 25573069

  • 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.

    PubMed 27898202

  • 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.

    PubMed 29580658

  • 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.

    PubMed 30217648

  • 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.

    PubMed 33894832

  • 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.

    PubMed 16110428

  • 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.

    PubMed 34766518

Questions about this trial

What is this clinical trial studying?

A study testing taVNS and FTP in people with Traumatic Brain Injury and Upper Extremity, run by Craig Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Candy Tefertiller, PT, DPT, PhD, NCS (303-789-8251, ctefertiller@craighospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of intervention (time frame: From enrollment to the end of treatment at 4 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07867015, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

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