Transcutaneous Electrical Spinal Stimulation (tSCS) for Improving Upper Limb Function in People With MS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Upper Limb Function (9-Hole Peg Test)
研究概览
简要总结
The goal of this clinical trial is to evaluate whether non-invasive spinal cord neuromodulation with the SCONE™ device can improve upper limb function in people with multiple sclerosis. The study will investigate if combining SCONE™ therapy with rehabilitation exercises leads to improvements in arm and hand movement, and whether the therapy is safe and well tolerated in this patient population. Participants will receive non-invasive spinal cord stimulation with the SCONE™ device and perform rehabilitation exercises specifically focused on the upper limb.
详细描述
This is a pilot, randomized, placebo-controlled study designed to evaluate the efficacy and safety of transcutaneous spinal cord stimulation (tSCS) in improving upper limb function in patients with Multiple Sclerosis (MS).
tSCS is a non-invasive neuromodulation technique that delivers low-intensity electrical impulses through the skin to specific spinal segments. This external stimulation aims to enhance spinal excitability and restore communication between the brain and spinal circuits affected by MS. Previous research in spinal cord injury has demonstrated functional improvements in motor performance with tSCS, suggesting its potential benefit in MS-related disability.
In this study, participants with clinically confirmed MS and upper limb impairment will first undergo a 6-week period of standard occupational therapy. After this run-in phase, they will be randomly assigned in a 1:1 ratio to receive either active tSCS or sham stimulation for an additional 6 weeks, while continuing occupational therapy. The intervention will be delivered at the rehabilitation center of Hospital de la Esperanza, in a seated position, using surface electrodes placed at the posterior cervical region. Sessions will last approximately 30 minutes, three times per week (preferably Monday, Wednesday, and Friday).
The sham condition will mimic the procedure using the same equipment and electrode placement but without delivering effective stimulation. After completion of the blinded phase, participants originally randomized to sham will be offered the opportunity to receive active tSCS in an open-label extension.
The primary efficacy endpoint is improvement in upper limb function, assessed by the Nine-Hole Peg Test (9HPT). Secondary endpoints include the Action Research Arm Test (ARAT), patient-reported outcomes (NeuroQOL - Upper Extremity Function, Modified Fatigue Impact Scale [MFIS], and Global Impression of Change [GIC]), and clinical safety measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70 years.
- •Diagnosis of Multiple Sclerosis (according to revised McDonald criteria).
- •Upper limb dysfunction (9-Hole Peg Test score ≥ 20% slower than normative values).
- •Stable disease-modifying treatment for ≥ 6 months before enrollment.
- •Expanded Disability Status Scale (EDSS) score between 3.0 and 6.
- •Ability to provide informed consent.
排除标准
- •Relapse or corticosteroid treatment within the last 3 months.
- •Severe spasticity of the upper limb (Modified Ashworth Scale > 3).
- •Implanted electrical devices (pacemaker, spinal cord stimulator).
- •Epilepsy or uncontrolled seizures.
- •Severe psychiatric disorders or cognitive impairment interfering with study procedures.
- •Pregnant or breastfeeding women.
- •Participation in another interventional clinical trial within the last 3 months.
结局指标
主要结局
Change in Upper Limb Function (9-Hole Peg Test)
时间窗: Baseline and Week 12
The 9-Hole Peg Test (9HPT) is a validated quantitative measure of upper extremity function. Participants are timed while placing and removing nine pegs into holes on a board as quickly as possible. Performance is recorded as time to completion. Change from baseline will be compared between active and sham groups.
次要结局
- Change in Hand Grip Strength (Dynamometry)(Baseline and Week 12)
- Change in Quality of Life (EQ-5D-5L)(Baseline and Week 12)
- Change in Fatigue (Modified Fatigue Impact Scale - MFIS)(Baseline and Week 12)
- Change in Manual Dexterity (Box and Block Test)(Baseline and Week 12)
- Patient-Reported Upper Limb Function (Multiple Sclerosis Impact Scale - MSIS-29, upper limb subitems)(Baseline and Week 12)
- Safety and Tolerability(Baseline through Week 12)
研究者
PAblo Villoslada
Principal Investigator, Neurology Department, Hospital del Mar Research Institute
Parc de Salut Mar