Transcutaneous Direct Current Stimulation of the Spinal Cord for Treatment of Spasticity in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Gait improvement
研究概览
简要总结
The current research is aimed at using Transcutaneous Spinal Direct Current Stimulation (tSDCS) as complementary therapeutic tool in the treatment of spasticity in multiple sclerosis. Patients will be randomized into two groups (tSDCS-anode vs. tSDCS-sham) according to the detailed protocol. Main outcome will be measured by the change in walking speed using the Timed 25-Foot Walk (T25FW).
A total of 40 patients ought to be enrolled as specified in methodology. Secondary outcomes will assess functional improvement through Multiple Sclerosis Walking Scale (MSWS) Short Form - 36 (SF-36), Expanded Disability Status Scale (EDSS) and Ashworth scale.
详细描述
Spasticity is experienced in around 80 % of patients with multiple sclerosis resulting in quality of life impairment. Transcranial direct current stimulation has been proven effective for the treatment of spasticity in patients with chronic stroke or cerebral palsy. The effect of transcutaneous spinal direct current stimulation (tSDCS) has been applied in spasticity but not in patients with spasticity due to multiple sclerosis. The study aims to assess the efficacy of anodal tSDCS on spasticity in multiple sclerosis patients through several assessment tools. The investigators hypothesize that anodal tSDCS will reduce spasticity in multiple sclerosis patients.
The study will be double blind sham-controlled crossover. The patients will be examined by the described assessment tools (T25FW, MSWS, SF-36, Ashworth, EDSS) before receiving tSDCS. The sessions of tSDCS will be applied 1 session per day in 5 consecutive days. Assessment using the scales and questionnaires will be performed at the end of the 5 days of stimulation, 1 week after the last day of first block of sessions and 2 weeks later. The group will be crossed and another block of 5 consecutive days of stimulation will follow. Assessment will take place again on first day and last day of the stimulations followed as well by assessment 1 week after the last day of second block of stimulation and 2 weeks after.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Multiple Sclerosis according to the 2010 Mc Donald criteria with spasticity in the lower extremities
排除标准
- •Cardiac pacemakers
- •Patients with prior exposure to tDCS
- •Metallic hardware in the spine
- •Eczema or skin abrasion at the intended site of stimulation
- •Currently pregnant or plan for pregnancy in the next 6 months
- •Heart or respiratory failure resulting in activity impairment
- •Walking impairment due to orthopaedics condition such as deformity or recent fracture.
研究组 & 干预措施
Active tSDCS
Anodal tSDCS will be administered through a pair of conductive rubber electrodes covered by saline soaked sponges (35 cm2). The current will be delivered continuously at 2 mA for 30 min through a battery-driven constant-current stimulator (designed by Sooma). The anode will be positioned over the spinal cord area at the level of the spinous processes of 10th-11th thoracic vertebra.
干预措施: Transcutaneous Spinal Direct Current Stimulation (Device)
Sham tSDCS
Sham stimulation will be delivered to the same spinal cord area using a sham tSDCS device that delivers a direct current for 10 seconds at the beginning and end of tSDCS to provide sensory experiences similar to active stimulation.
干预措施: Transcutaneous Spinal Direct Current Stimulation (Device)
结局指标
主要结局
Gait improvement
时间窗: 5 days
The primary objective of the study is to achieve 20% gait speed improvement on 25 feet walking test (T25WT) after spasticity reduction by cathodal tSDCS.
次要结局
- Multiple Sclerosis Walking Assessment(19 days)
- Quality of Life Measures(19 days)
- Disability Measure(19 days)
- Spasticity Assessment(19 days)
研究者
Rechdi Ahdab
M.D , PhD, Clinical Professor
Lebanese American University