Yozbatiran Nuray, Francisco Gerard E, Korupolu Radha
Neuromodulation and Neural Interfaces Laboratory, UTHealth NeuroRecovery Research Center at TIRR Memorial Hermann, Houston, TX, United States.
Department of Physical Medicine and Rehabilitation, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX, United States.
Front Neurol. 2024 Nov 14;15:1465764. doi: 10.3389/fneur.2024.1465764. eCollection 2024.
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 after SCI. Hence, this pilot randomized controlled trial aims to evaluate the safety, feasibility, and potential efficacy of pairing vagus nerve stimulation (VNS) with rehabilitation therapy to restore the motor function of the paretic upper limbs in people with cervical SCI.
In this triple-blind, randomized, sham-controlled pilot study, 8 adults with chronic incomplete SCI will be implanted with a VNS device and randomly assigned to either active VNS (0.8 mA) control VNS (0.0 mA) paired with upper limb rehabilitation. Each participant will undergo 18 in-clinic therapy sessions over 6 weeks, each lasting 120 min and delivered three times per week. Following the in-clinic phase, participants will continue with a 90-day home exercise program. Participants in both groups will receive similar goal-directed and intense upper limb rehabilitation. The therapy is focused 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 (0.8 mA) 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.
ClinicalTrials.gov, NCT05601661.
将迷走神经刺激与传统康复疗法相结合可改善中风患者的运动恢复。然而，这种方法尚未在脊髓损伤（SCI）患者中进行研究。脊髓损伤后运动恢复仍然具有挑战性，因此需要创新的研究策略来增强脊髓损伤后的运动恢复。因此，这项初步随机对照试验旨在评估将迷走神经刺激（VNS）与康复疗法相结合以恢复颈髓损伤患者瘫痪上肢运动功能的安全性、可行性和潜在疗效。
在这项三盲、随机、假对照的初步研究中，8名慢性不完全性脊髓损伤的成年人将植入VNS设备，并随机分配到接受有效VNS（0.8毫安）或对照VNS（0.0毫安）并结合上肢康复治疗的组中。每位参与者将在6周内接受18次门诊治疗，每次持续120分钟，每周进行三次。门诊治疗阶段结束后，参与者将继续进行为期90天的家庭锻炼计划。两组参与者都将接受类似的目标导向且高强度的上肢康复治疗。该治疗侧重于主动运动、任务特异性、高重复次数、可变练习以及参与者的积极参与。治疗后评估将在门诊治疗结束后立即进行，并在随访第30天和第90天进行。在90天随访结束揭盲后，对照组参与者将接受为期6周的门诊有效VNS（0.8毫安）结合康复治疗。将通过每组不良事件的发生情况评估VNS与康复相结合的安全性，通过参与治疗 sessions和随访就诊的次数以及退出人数评估可行性。潜在疗效将通过测量从基线到门诊治疗结束后立即以及到90天时重新定义的力量、感觉和抓握分级评估（GRASSP）表现的变化来评估。次要临床结局指标包括多伦多康复研究所手功能测试量表、上肢能力问卷、脊髓损伤独立性测量-III自理子量表以及脊髓损伤生活质量量表。
试验方案已获得德克萨斯大学健康科学中心机构审查委员会（HSC-MS-22-0579）的批准。我们预计在研究完成后1年内将结果发表在同行评审期刊上。
ClinicalTrials.gov，NCT-05601661。
