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STUDY PROTOCOL article
Front. Neurol.
Sec. Neurorehabilitation
Volume 15 - 2024 |
doi: 10.3389/fneur.2024.1465764
This article is part of the Research Topic Transforming Neurological Recovery: The Promise of Regenerative Neurorehabilitation View all articles
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 randomised controlled trial
Provisionally accepted- University of Texas Health Science Center at Houston, Houston, United States
Introduction Pairing vagus nerve stimulation with traditional rehabilitation therapies results in improved motor recovery in people with stroke. However, this approach has not yet been studied in people with spinal cord injury (SCI). Motor recovery continues to be challenging after SCI, and there is a need for innovative research strategies to enhance motor recovery.Hence, this pilot randomised controlled trial aims to evaluate the safety, feasibility, and potential efficacy of pairing vagus nerve stimulation (VNS) with rehabilitation to restore the motor function of the paretic upper limbs in people with cervical SCI.In this triple-blind, randomised, sham-controlled pilot study, 8 adults with chronic incomplete SCI will be implanted with a VNS device and randomly assigned to either active VNS (0.8mA) or control VNS (0.0mA) paired with upper limb rehabilitation. Participants will undergo 18 in-clinic therapy sessions over six weeks, lasting 120 minutes each delivered three times per week. Following in-clinic phase, participants will continue with a 90-day home exercise programme. Rehabilitation therapy consist of goal directed tasks focusing on active movements, task specificity, high number repetitions, variable practice, and active participant engagement.Post-treatment assessment will occur immediately after in-clinic therapy and at 30 and 90 days of follow-up. After completion of blinding at 90 days follow-up, participants in the control group will be offered 6 weeks of in-clinic active VNS (0.8mA) paired with rehabilitation. The safety of pairing VNS with rehabilitation will be assessed by the occurrence of adverse events in each group, and feasibility by the number of treatment sessions and follow-up visits attended and the number of dropouts. Potential efficacy will be assessed by measuring the change in Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) performance from baseline to immediately after in-clinic therapy and to 90 days. Secondary clinical outcome measures are the Toronto Rehabilitation Institute Hand Function Test, Capabilities of Upper Extremity Questionnaire, Spinal Cord Injury Independence Measure-III self-care subscore, and Spinal Cord Injury-Quality of Life scale.The trial protocol was approved by the Institutional Review Board of UTHealth (HSC-MS-22-0579). We anticipate publishing the results in a peer-reviewed journal within 1 year of study completion.Trial registration number ClinicalTrials.gov (NCT05601661).
Keywords: Vagus Nerve Stimulation, spinal cord injury, Rehabilitation, Upper Extremity, motor recovery
Received: 16 Jul 2024; Accepted: 31 Oct 2024.
Copyright: © 2024 Yozbatiran, Francisco and Korupolu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Radha Korupolu, University of Texas Health Science Center at Houston, Houston, United States
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