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Cervical Spinal Cord InjuryNCT05601661

Safety and Feasibility of Paired Vagus Nerve Stimulation With Rehabilitation for Improving Upper Extremity Function in People With Cervical Spinal Cord Injury

A study testing Active VNS and Arm rehabilitation in people with Cervical Spinal Cord Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the safety and feasibility of pairing vagus nerve stimulation (VNS) with rehabilitation and to determine the efficacy of pairing VNS with rehabilitation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cervical Spinal Cord Injury
What is being tested?
Active VNS and Arm rehabilitation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6 participants
Where
1 siteUnited States
Study dates
15 Jun 2023to 16 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

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

  • a diagnosis of traumatic incomplete (AIS B-D) cervical spinal cord injury (C8 and above)
  • at least 12 months post-traumatic SCI
  • demonstrate some residual movement in the upper limb (e.g., able to perform pinch movement with thumb and index finger)
  • meet all clinical criteria for the surgical VNS implantation as determined by the PI, neurosurgeon, and anesthesiologist.

Who cannot join

  • non-traumatic SCI, injury
  • presence of ongoing dysphasia or aspiration difficulties
  • evidence of vagus pre-existing vocal cord paralysis as determined with laryngoscopy procedure
  • participants with prior left-sided anterior cervical surgery who exhibit too much of scar tissue at the surgery site which will be determined by neurosurgeon
  • concomitant clinically significant brain injury
  • history of prior injury to a vagus nerve
Show all 10Show fewer
  • receiving medication that may significantly interfere with the actions of VNS on neurotransmitter systems at study entry
  • other comorbidities or complications that will hinder or contraindicate surgical procedure
  • medical or mental instability
  • pregnancy or plans to become pregnant during the study period.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Safety and Feasibility of Paired Vagus Nerve Stimulation With Rehabilitation for Improving Upper Extremity Function in People With Cervical Spinal Cord Injury: A Pilot Randomized Control Trial.

The purpose of this study is to determine the safety and feasibility of pairing vagus nerve stimulation (VNS) with rehabilitation and to determine the efficacy of pairing VNS with rehabilitation.

Read the detailed description

The current study will evaluate the safety and feasibility of a novel rehabilitation protocol to improve upper limb motor recovery in adults with incomplete cervical SCI. In this double-blinded, randomized, placebo-controlled pilot trial, 8 adults (above 18 years) with cervical SCI will be randomly assigned in a 1:1 ratio to active VNS paired with rehabilitation or control VNS paired with rehabilitation. All participants will be implanted with a VNS device and randomized to receive either active VNS (0.8mA) or control VNS (0.0 mA) paired with upper limb rehabilitation. All participants will receive three 1.5-hour sessions per week for 6 weeks of in-clinic therapy, followed by a daily, 30 minutes home therapy program for 90 days. The rehabilitation therapy involves repetitive, progressive, task-specific exercises adjusted to the participant's functional level. Participants, assessors, and therapists will maintain blinding until the completion of this phase. After 90 days, in phase II, participants in the control VNS group will cross over to receive active VNS paired with rehabilitation. Safety and feasibility measures are the primary outcomes of this study. Safety measures will include the incidence of surgical and VNS therapy-related events. Feasibility metrics include reporting attrition rate and compliance rate with both in-clinic therapy sessions and home exercise programs. To measure efficacy, change in Graded and Redefined Assessment of Strength, Sensibility, and Prehension from baseline to immediately after 6-week in-clinic treatment and 90-day assessment will be analyzed. Additional clinical outcomes include the Toronto Rehab Institute Hand Function Test, Capabilities of Upper Extremity Questionnaire, spinal cord injury independence self-care measure, and spinal cord injury quality of life. The results of this study will provide valuable information on safety and feasibility and insight into the efficacy of pairing VNS with rehabilitation in people with SCI. Knowledge obtained from this study will lay the groundwork for future large randomized control trials to assess the dosing and effectiveness of pairing VNS with rehabilitation.

Being tested
Active VNS, Sham VNS, Arm rehabilitation
Keywords
vagus nerve stimulation

What participants receive

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

  • Active VNSDevice

    An implantable system consisting of an implantable neurostimulator (model 1001 Implantable Pulse Generator (IPG)) and an implantable lead and electrode (Model 30000 VNS lead) will be used. An external system consisting of an external controller (Model 2000 Wireless Transmitter) and an external software system (computer and Model 4001 Microtransponder SAPS® software) will provide clinical control of settings for the implantable pulse generator (IPG) . All VNS devices (Vivistim System® ) will be provided as a donation by Microtransponder Inc. The device is programmed to stimulate for 0.5s on each button push. After surgical recovery, participants will receive five stimulations in reducing strength (starting at 0.8mA and then reducing to 0.1mA each step) at the beginning of each therapy session, followed by stimulation (0.8 mA)

  • Sham VNSDevice

    An implantable system consisting of an implantable neurostimulator (model 1001 Implantable Pulse Generator (IPG)) and an implantable lead and electrode (Model 30000 VNS lead) will be used. An external system consisting of an external controller (Model 2000 Wireless Transmitter) and an external software system (computer and Model 4001 Microtransponder SAPS® software) will provide clinical control of settings for the implantable pulse generator (IPG) . All VNS devices (Vivistim System® ) will be provided as a donation by Microtransponder Inc. The device is programmed to stimulate for 0.5s on each button push. After surgical recovery, participants will receive five stimulations in reducing strength (starting at 0.8mA and then reducing to 0.1mA each step) at the beginning of each therapy session, followed by stimulation (0 mA)

  • Arm rehabilitationOther

    . The rehabilitation therapy involves arm and hand exercises with objects. The therapist will select these exercises based on movement abilities. Tasks will be selected from six functional task categories: reach and grasp, gross movement, object flipping, simulated eating tasks, inserting objects, and opening containers. Approximately 30-50 repetitions will be performed in each category. On average, 300-500 repetitions will be performed during each session within 1.5-2hours.

Study groups in NCT05601661
Study groupRoleWhat they receive
Treatment groupExperimentalParticipants in the treatment group will receive 18 goal-directed upper extremity rehabilitation therapy sessions with paired VNS over six weeks. Followed by 90 days home exercise program.
Receives: Device: Active VNS; Other: Arm rehabilitation
Control GroupSham comparatorParticipants in the control group will receive 18 goal-directed upper extremity rehabilitation therapy sessions with sham VNS over six weeks. Followed by 90 days home exercise program.
Receives: Device: Sham VNS; Other: Arm rehabilitation

What is being measured

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

  1. Safety as assessed by number of subjects with post surgical complications

    post-surgical complications include but are not limited to dysphagia, hematoma, hoarseness of voice, vocal cord paralysis, edema, pain, and post-surgical infection

    Measured: 90-day follow-up

  2. Safety as assessed by number of subjects with change in systolic blood pressure

    Measured: pretreatment, post treatment (about 6 weeks after pre treatment )

  3. Safety as assessed by number of subjects with change in diastolic blood pressure

    Measured: pretreatment, post treatment (about 6 weeks after pre treatment )

  4. Safety as assessed by number of subjects with change in heart rate

    Measured: pretreatment, post treatment (about 6 weeks after pre treatment )

  5. Safety as assessed by number of subjects with change in respiratory rate

    Measured: pretreatment, post treatment (about 6 weeks after pre treatment )

  6. Safety as assessed by number of subjects with change in autonomic dysreflexia

    Measured: pretreatment, post treatment (about 6 weeks after pre treatment )

  7. Safety as assessed by number of subjects with worsening spasticity

    Measured: pretreatment, post treatment (about 6 weeks after pre treatment )

  8. Safety as assessed by number of subjects with change in pain at stimulation site

    Measured: pretreatment, post treatment (about 6 weeks after pre treatment )

  9. Feasibility as assessed by the number of participants that completed all the sessions

    Measured: end of study(about 132 days after enrollment)

  10. Feasibility as assessed by the number of participants that dropped out of the study

    Measured: end of study(about 132 days after enrollment)

Secondary outcomes (7)

  1. Change in hand function as assessed by the Toronto Rehab Institute Hand Function Test (TRI-HFT)

    This is a 14 item questionnaire and each is scored from 1(no movement elicited) to 8(normal grasp) a higher number indicating better hand function

    Measured: baseline, post-treatment (first day after 6 week inclinic therapy), 30 days, and 90 days follow-up.

  2. Change in capability of using arms and hands as assessed by the Capabilities of Upper Extremity Questionnaire (CUE-Q)

    This is a 17 item questionnaire and each is scored from 1(totally limited) to 7(not at all limited), a higher number indicating better outcome

    Measured: baseline, post-treatment (first day after 6 week inclinic therapy), 30 days, and 90 days follow-up.

  3. Change in self care independence as assessed by the Spinal Cord Injury Independence Measure-III (SCIM-III) self-care subscore

    This is a 4 item questionnaire and each is scored from 0(need total assistance) to 3(completely independent), higher score indicating more independence.

    Measured: baseline, post-treatment (first day after 6 week inclinic therapy), 30 days, and 90 days follow-up.

  4. Quality of Life as assessed by the Spinal Cord Injury- Quality of Life (SCI-QoL) questionnaire

    This questionnaire has 3 parts:

    1. basic mobility: this is a 11 item questionnaire and each is scored from 1(unable to do) to 5(can do without difficulty)higher score indicating more mobility
    2. Fine Motor: This is a 9 item questionnaire and each is scored from 1(unable to do) to 5(can do without difficulty)higher score indicating better outcome
    3. self care: This is a 11 item questionnaire and each is scored from 1(unable to do) to 5(can do without difficulty)higher score indicating better outcome

    Measured: baseline, post-treatment (first day after 6 week inclinic therapy), 30 days, and 90 days follow-up.

  5. Change in Pain as assessed by the International SCI pain basic data subset (version 2).

    This is an 6 item questionnaire and each is scored from 0 (no pain) -10 (pain as bad as you can imagine), a higher score indicating more pain.

    Measured: baseline, post-treatment (first day after 6 week inclinic therapy), 30 days, and 90 days follow-up.

  6. Change in Depression as assessed by the Patient Health Questionnaire (PHQ-8)

    This is an eight item questionnaire and each is scored from 0(not at all) to 3(nearly every day) a higher score indicating worse outcome

    Measured: baseline, post-treatment (first day after 6 week inclinic therapy), 30 days, and 90 days follow-up.

  7. Change in degree of upper limb impairment as assessed by the Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP) survey.

    The 3 measured domains are as follows:

    1. Strength: Motor grading of 10 arm and hand muscles for right and left arm will be performed. Each muscle is graded from 0 to 5 for a maximum score of 50, a higher number indicating more strength.
    2. Dorsal and palmar sensation: Each test location is scored from 0 to 4. Three locations for the dorsal side of each hand and 3 for palmer location of each hand are summed to render a subtest total score between 0 and 12 a higher score indicating more sensation.
    3. Prehension:
    4. Qualitative prehension: The participant performs 3 tasks using each hand and is scored from 0-12 a higher number indicating a better outcome
    5. Quantitative prehension: he participant performs 6 tasks using each hand and is scored from 0-30 a higher number indicating a better outcome

    Measured: baseline, post-treatment (first day after 6 week inclinic therapy), 30 days, and 90 days follow-up.

Timeline

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

  1. First posted1 Nov 2022
  2. Study start15 Jun 2023
  3. Primary completion16 Aug 2025
  4. Study completion16 Aug 2025

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
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05601661
Sponsor's protocol ID
HSC-MS-22-0579
Status last verified
Oct 2025
First submitted
17 Oct 2022
Last updated
28 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Korupolu R, Yozbatiran N, Miller A, Shields M, Tandon N. Safety and feasibility of paired vagus nerve stimulation with rehabilitation for improving upper extremity function in people with cervical spinal cord injury: a pilot randomized controlled trial. Front Rehabil Sci. 2026 Jun 11;7:1805955. doi: 10.3389/fresc.2026.1805955. eCollection 2026.

    PubMed 42367680

  • Yozbatiran N, Francisco GE, Korupolu R. Safety and feasibility of paired vagus nerve stimulation with rehabilitation for improving upper extremity function in people with cervical spinal cord injury: study protocol for a pilot randomized controlled trial. Front Neurol. 2024 Nov 14;15:1465764. doi: 10.3389/fneur.2024.1465764. eCollection 2024.

    PubMed 39610700

Questions about this trial

What is this clinical trial studying?

A study testing Active VNS and Arm rehabilitation in people with Cervical Spinal Cord Injury, run by The University of Texas Health Science Center, Houston 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 28 Oct 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety as assessed by number of subjects with post surgical complications (time frame: 90-day follow-up). The study lists 10 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 NCT05601661, which also lists 2 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 28 Oct 2025.

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