Targeted Plasticity Therapy for Upper Limb Rehabilitation in Spinal Cord Injuries
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ClinicalTrials.gov Identifier: NCT04288245 |
Recruitment Status :
Not yet recruiting
First Posted : February 28, 2020
Last Update Posted : December 31, 2020
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Condition or disease | Intervention/treatment | Phase |
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Spinal Cord Injuries Upper Extremity Paresis | Device: Active Vagus Nerve Stimulation Device: Placebo Vagus Nerve Stimulation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | Double blind, randomized placebo controlled, optional open-label extension design |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Device Feasibility |
Official Title: | Targeted Plasticity Therapy for Upper Limb Rehabilitation in Spinal Cord Injuries |
Estimated Study Start Date : | January 2021 |
Estimated Primary Completion Date : | January 2022 |
Estimated Study Completion Date : | January 2026 |

Arm | Intervention/treatment |
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Experimental: Immediate Start Vagus Nerve Stimulation group
The Immediate Start VNS group will receive rehabilitation and active stimulation for 18 in-office sessions over the course of approximately 6 weeks during phase 1. For phase 2, all subjects will be provided the option to participate in an open-label extension consisting of an additional 18 sessions of in-office rehabilitation with active VNS over the course of approximately 6 weeks. Participants that elect to continue in the open-label extension will be assessed approximately 1 week after the conclusion of the additional 18 sessions of therapy.
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Device: Active Vagus Nerve Stimulation
Stimulation of the vagus nerve that is paired with upper extremity rehabilitation. VNS stimulation as described in the current study consists of 0.5 s trains of 0.8 mA 100 µs biphasic pulses delivered at 30 Hz. Stimulation trains are delivered only during rehabilitation.
Other Names:
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Placebo Comparator: Delayed Start Vagus Nerve Stimulation group
The Delayed Start VNS group will receive equivalent rehabilitation with placebo stimulation for 18 in-office sessions over the course of approximately 6 weeks during phase 1. For phase 2, all subjects will be provided the option to participate in an open-label extension consisting of an additional 18 sessions of in-office rehabilitation with active VNS over the course of approximately 6 weeks. Participants that elect to continue in the open-label extension will be assessed approximately 1 week after the conclusion of the additional 18 sessions of therapy.
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Device: Placebo Vagus Nerve Stimulation
During Phase 1 of the study, the placebo group will receive a minimal amount of stimulation that fails to sufficiently activate the nerve, unknown to the participant and therapists. All participants will receive active stimulation during the Phase 2 open-label portion of the study.
Other Names:
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- Incidence of Adverse Events [Device Safety] [ Time Frame: From Week 1 through study follow-up, approximately two years from the date of implant ]Review of adverse events reported throughout the trial will be used to inform the potential risks associated with the ReStore system and provide a better understanding of risk/benefit analysis.
- Restore System Feasibility during Rehabilitation [ Time Frame: Weeks 7-12, Weeks 14-19 ]If stimulation delivery is successful during the active portion of therapy sessions then the system is feasible to use. The primary endpoint will be: greater than 50% of the valid attempts to stimulate are successful per the ReStore system log.
- Quantitative Force and Range of Motion Assessment [ Time Frame: Week 1, 6, 13, 20 ]This is a physical assessment of upper limb changes in force/torque as a result of VNS paired rehabilitation. The primary endpoints will be: 10% increase in finger pinch and flexion force following active VNS, 10% increase in wrist flexion and extension force following active VNS, and 10% increase in wrist pronation and supination force following active VNS. This will serve as an efficacy measurement to use as basis for estimate of sample size for a pivotal trial.
- Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) [ Time Frame: Week 1, 6, 13, 20 ]Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) is a measure used for spinal cord injury patients. The measure includes five subsets of questions designed to quantitatively measure clinical upper limb impairment (Kalsi-Ryan et al., 2012). The primary endpoint will be: >4 point shift in GRASSP assessment following active VNS. This will serve as an efficacy measurement to use as basis for estimate of sample size for a pivotal trial.

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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Adult, aged 18-64
- In good general health as evidenced by medical history and diagnosed with first time cervical spinal cord injury resulting in an ASIA grade B, C, or D, and level 1 or better motor function as described by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI).
- SCI caused by trauma that occurred ≥ 12 months prior to enrollment
- Meets all clinical criteria for the surgical VNS implantation as determined by the PI, surgeon, and anesthesiologist
- Must demonstrate some residual upper limb and hand movement in either arm
- Appropriate candidate for VNS implantation
- Willing and able to comply with the study protocol
Exclusion Criteria
An individual who meets any of the following criteria will be excluded from participation in this study:
- Spinal cord injuries by sharp objects, firearms, and non-traumatic or congenital causes, even if at different levels of the spinal cord
- Participants with prior right-sided anterior cervical surgery will require laryngoscopy prior to randomization. Those with evidence of recurrent laryngeal nerve injury will be excluded.
- Participants with prior left sided anterior cervical surgery will be eligible, regardless of prior recurrent laryngeal nerve injury. However, if at surgery there is too much scar tissue for safe implantation the surgery will be abandoned to ensure participant safety
- Concomitant clinically significant brain injuries
- Prior injury to vagus nerve
- Prior or current treatment with vagus nerve stimulation
- Participant receiving any therapy (medication or otherwise) that would interfere with VNS
- Pregnancy or lactation
- Clinical complications that hinder or contraindicate the surgical procedure
- Psychiatric disorders, psychosocial, and/or cognitive impairment that would interfere with study participation, as assessed by medical evaluation
- Abusive use of alcohol and/or illegal substances use
- Participation in other interventional clinical trial
- Participants with known immunodeficiency including participants who are receiving or have received chronic corticosteroids, immunosuppressants, immunostimulating agents or radiation therapy within 6 months
- Participants with significant comorbidities or conditions associated with high risk for surgical or anesthetic survival (e.g. renal failure, peripheral vascular disease, unstable cardiac disease, poorly controlled diabetes, immunosuppression, etc.).
- Participants with active neoplastic disease.
- Participants with significant local circulatory problems, (e.g. thrombophlebitis and lymphedema, and clinically-significant hypotension or bradycardia).
- Participants with any medical condition or other circumstances that might interfere with their ability to return for follow-up visits in the judgment of the Investigator.
- Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of device's safety and performance.
- Aphasia and other cognitive deficits may be present but participants will be excluded if are unable to understand the potential risks and benefits of the study or personally provide informed consent.
- A recent history of syncope
- A recent history of dysphagia
- Currently require, or are likely to require diathermy
- Significant respiratory issues that would interfere with participation
- Non-English speaking
- Patients who are acutely suicidal and/or have been admitted for a suicide attempt
- Incarceration or legal detention

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04288245
Contact: Victoria Warren, RN | 214-563-9001 | victoria.warren@utdallas.edu | |
Contact: Emma Turner, BA | 214-865-2416 | emma.turner@bswhealth.org |
Principal Investigator: | Michael Kilgard, PhD | University of Texas at Dallas | |
Principal Investigator: | Robert Rennaker, PhD | University of Texas at Dallas | |
Study Director: | Seth Hays, PhD | University of Texas at Dallas | |
Principal Investigator: | Jane Wigginton, MD | University of Texas Southwestern Medical Center | |
Principal Investigator: | Rita Hamilton, DO | Baylor Scott & White Institute for Rehabilitation | |
Study Director: | Michael Foreman, MD FACS | Baylor Health Care System | |
Study Director: | Mark Powers, PhD | Baylor Health Care System | |
Study Director: | Richard Naftalis, MD, FAANS, FACS | Baylor Health Care System |
Responsible Party: | Baylor Research Institute |
ClinicalTrials.gov Identifier: | NCT04288245 |
Other Study ID Numbers: |
019-356 N66001-17-2-4011 ( Other Grant/Funding Number: Naval Information Warfare Center, Pacific ) |
First Posted: | February 28, 2020 Key Record Dates |
Last Update Posted: | December 31, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Vagus Nerve Stimulation (VNS) Rehabilitation Targeted Plasticity Therapy |
Spinal Cord Injuries Paresis Wounds and Injuries Spinal Cord Diseases |
Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Neurologic Manifestations |