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
|Condition or disease||Intervention/treatment||Phase|
|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|
|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|
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.
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.
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.
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.
- 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.
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, RNemail@example.com|
|Contact: Emma Turner, BAfirstname.lastname@example.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|