Reducing Fatigue in People With Multiple Sclerosis by Treatment With Transcutaneous Electrical Nerve Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Walking limitations
研究概览
简要总结
The objective of the randomized, sham-controlled trial will be to evaluate the effectiveness of treatment with transcutaneous electrical nerve stimulation (TENS) at reducing the level of fatigue experienced by people with MS.
详细描述
We will compare the changes in self-reported levels of fatigue (symptom intensity) and measures of fatigability (work capacity) from before to after a 6-week intervention. Participants (18-65 yrs) will be randomly assigned to one of two groups: one group will receive an effective dose of TENS and the other group (control) will be given a sham dose of TENS. The treatment will be applied during 18 sessions (3x/week for 6 weeks) and delivered through electrodes placed on the skin overlying the dorsiflexor (tibialis anterior) and hip flexor (rectus femoris) muscles of both legs. Participants will be evaluated before (Week 0), during (Week 4), and after (Weeks 7 and 11) the 6-week intervention.
Our long-term goal is to develop strategies that can reduce the impact of fatigue on the daily activities of persons with MS. The objective of the randomized, sham-controlled trial will be to evaluate the effectiveness of treatment with TENS at reducing the level of fatigue experienced by people with MS. Our central hypothesis is that treatment with TENS applied to selected leg muscles in people with MS will produce superior improvements in self-reported and measured levels of fatigue and fatigability compared with a sham dose of TENS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women18-65 yrs
- •Able to read, understand, and speak English to ensure safe participation in the project
- •Clinical diagnosis of relapsing-remitting MS
- •Self-reported difficulty with walking
- •On stable doses of Ampyra, provigil, or other symptomatic-treating medications
- •No relapse or systemic steroids within the last 30 days
- •Able to arrange transportation to the Boulder campus
排除标准
- •Vision or hearing problems that have not been corrected
- •Problems with sensations to temperature, pressure, or pain
- •Any arm or leg problems that would influence the ability to hold a weight
- •Surgery to the arms or legs that continues to bother the participant
- •Metal implants
- •Medical diagnosis or condition that is considered to be an absolute or relative contraindication to participating in exercise training, such as major renal, pulmonary, hepatic, cardiac, gastrointestinal, HIV, cancer (other than treated basal cell cancer), other neurological disorders, or pregnancy
- •History of head injury or stroke
- •Taking antidepressants, anticholinergics, stimulants, sedatives, cannabis, illicit drugs or medications to treat herpes or neurologic pain.
- •Diagnosis of diabetes mellitus
- •Poorly controlled hypertension
- •History of seizure disorders
- •≥2 alcoholic drinks/day, or present history (last 6 months) of drug abuse
- •Spasticity that requires the individual to change intended activities more often than once a week
- •Skin diseases or sensation problems in the legs or hands that influences some activities more often than once a week
- •Inability to attend exercise sessions 3 days per week for 6 weeks
结局指标
主要结局
Walking limitations
时间窗: Changes at Weeks 4, 7, and 11
Questionnaire scores - MS Walking Scale-12
Fatigue
时间窗: Changes at Weeks 4, 7, and 11
Questionnaire scores - PROMIS Fatigue (MS) 8a
Walking endurance
时间窗: Changes at Weeks 4, 7, and 11
6-min walk test in meters
Mobility
时间窗: Changes at Weeks 4, 7, and 11
Assessment of static and dynamic balance with Mobility Lab, APDM Inc
次要结局
- Quality of life questionnaire(Changes at Weeks 4, 7, and 11)
- Muscle strength(Changes at Weeks 4, 7, and 11)
研究者
Roger Enoka
Professor
University of Colorado, Boulder