Transcutaneous Electrical Stimulation for Spasticity in Patients With Primary Lateral Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Modified Ashworth Scale
研究概览
简要总结
The goal of this clinical trial is to determine if non-invasive electrical stimulation, using an electric stimulator placed on the skin of the patients back and abdomen for 30 minutes can reduce muscle spasms (spasticity) and improve walking function in patients with primary lateral sclerosis. Participants will attend one in-person clinic visit and participate in one telephone interview 24 hours after the treatment. The clinic visit will include pre-intervention, treatment and post-intervention assessments. The assessments will consist of a complete physical exam by the clinic neurologist followed by assessments and scoring of spasticity, deep tendon reflexes, gait quality, gait speed, gait endurance and balance. Patient's will rate their perceived spasticity pre, immediately post and 24 hours post treatment.
The treatment involves one 30-minute electrical stimulation session, which includes application of electrode pads to the patients back and abdomen. The patient will lay supine (on their back) with a pillow placed under their knees for comfort. The pads will then be connected to an FDA approved electrical stimulator. The electrical stimulator will be turned on and current adjusted to the individual patient based on small muscle contractions in their legs. Once the current is set, the patient will lay supine for 30 minutes. After 30 minutes, the device will be turned off and electrode pads removed.
详细描述
Objective: The primary aim of this preliminary pilot study is to assess the clinical effects of transcutaneous electrical stimulation (tES) in reducing spasticity in the lower extremities and increasing mobility in patients with Primary Lateral Sclerosis (PLS).
Study population: 6 patients with a confirmed diagnosis of PLS aged 18-90
Design:
Each enrolled participant will attend one in-person clinic visit and participate in one telephone interview 24 hours post-treatment.
The clinic visit will include pre-intervention, treatment and post-intervention assessments. The assessments will consist of a complete physical exam by the clinic neurologist followed by assessments and scoring of spasticity, deep tendon reflexes, gait quality, gait speed, gait endurance and balance. The patients will rate their perceived spasticity pre, immediately post and 24 hours post treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary lateral sclerosis by the treating neurologist
- •Ambulatory with or without a assistive device or orthotic
排除标准
- •History of cancer in the lumbar or thoracic spine
- •History of surgery with hardware in the lumbar or thoracic spine
- •Acute lower back pathology
- •Current pregnancy
- •History of implantable cardiac device
- •Diagnosis of significant cognitive impairment by the treating physician
- •History of seizures or diagnosis of epilepsy
- •Open wound at location of electrodes
- •Complete loss of sensation at the area of electrode placement
结局指标
主要结局
Modified Ashworth Scale
时间窗: through study completion, an average of 1 year
6 category ordinal scale (minimum value = 0 maximum value = 4) that measures spasticity where higher scores indicate greater spasticity
Modified Ashworth Scale
时间窗: Baseline (immediately pre-intervention) and immediately post-intervention (within 30 minutes of intervention).
The Modified Ashworth Scale (MAS) is an ordinal scale that ranges from 0 (no increase in muscle tone) to 4 (rigid flexion or extension). Ten muscle groups were assessed bilaterally from 0-4 yielding a possible score of 0-80 where higher values reflect more rigid muscles indicating a worse outcome.
次要结局
- 10-meter walk test (10MWT)(through study completion, an average of 1 year)
- Deep Tendon Reflex Scale(through study completion, an average of 1 year)
- 6 minute walk test (6MWT)(through study completion, an average of 1 year)
- Tinetti Performance Oriented Mobility Assessment(through study completion, an average of 1 year)
- 0-10 numeric rating scale(through study completion, an average of 1 year)
- Deep Tendon Reflex Scale(Baseline (immediately pre-intervention) and immediately post-intervention (within 30 minutes of intervention).)
- 10-meter Walk Test (10MWT)(Baseline (immediately pre-intervention) and immediately post-intervention (within 30 minutes of intervention).)
- 6 Minute Walk Test (6MWT)(Baseline (immediately pre-intervention) and immediately post-intervention (within 30 minutes of intervention).)
- Tinetti Performance Oriented Mobility Assessment(Baseline (immediately pre-intervention) and immediately post-intervention (within 30 minutes of intervention).)
- 0-10 Numeric Rating Scale(Baseline (immediately pre-intervention) and immediately post-intervention (within 30 minutes of intervention) and 24-hours post-intervention)