Nutrition, Neuromuscular Electrical Stimulation (NMES) and Secondary Progressive Multiple Sclerosis (SPMS)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Fatigue severity scale
研究概览
简要总结
The study will use a multimodal therapeutic lifestyle intervention consisting of a study diet, stressing more vegetables and fruit, elimination of foods at greatest risk for food allergy, meditation, self massage, progressive exercise and neuromuscular electrical stimulation for rehabilitation of gait and fatigue disability in the setting of secondary and primary progressive multiple sclerosis with gait disability.
详细描述
Restoration of function is very rare in individuals with MS who have experienced gradual worsening in the absence of acute MS symptoms (relapses) and partial or complete recovery of those acute symptoms (remissions).
A recent case report of a patient with secondary progressive MS documented a transition from scooter dependence to mild gait disability following the initiation of electrotherapy in the form of neuromuscular electrical stimulation and nutritional interventions aimed increasing the nutrient density and decreasing the risk of food sensitivity and food allergies. Multiple studies of neuromuscular electrical stimulation in athletes, cerebral palsy and stroke patients have demonstrated gains in strength and coordination. Multiple authors have reported that antioxidants, essential amino acids and micronutrient rich diets are neuroprotective. It is likely that the combination of the intensive nutrition and the electrotherapy contributed to the marked gains in improvement. However in the absence of an additional case report the strength of the association remains unknown.
The intent of this study is to replicate the interventions from the case report as closely as possible.
Our primary objective is to measure how many and how completely subjects implement 1) the nutritional interventions, 2) the home exercise program intervention, and 3) the electrotherapy intervention and if the improve improved nutrition and exercise are associated with improved function. To assess improvements in function will measure 1) the change in nutritional status as reported in food frequency surveys, 24 hr dietary recalls, 2) change in neurocognitive testing and behaviors, 3) change in self-reported function and disability scales, 4) change in gait and 5) change in medications doses or classes for MS related symptoms.
Subjects will be followed for three years. After the first year, subjects will not receive intensive support from the study team. The subjects return at months 18, 24 and 36 to assess adherence with study interventions, function and quality of life. Nutrition intake is assessed again at 24 and 36 months.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Secondary or primary progressive multiple sclerosis
- •Some level of gait disability
- •Tolerance for test electrical therapy session
- •Successful completion of two week Run-IN phase completing the daily logs -
- •Demonstrating > 80% compliance with dietary and behavioral interventions
排除标准
- •Antiplatelet or blood thinning medication
- •Cognitive disability or psychiatric disorder making compliance with study interventions difficult
- •Implanted electronic medical device
- •Change in medication in the prior three months
- •Active cancer treatment (skin basal cell or squamous cancer is not an exclusion criteria)
研究组 & 干预措施
Combined intervention
Combination intervention consisting of the following: structured modified paleolithic diet, Progressive Exercise, Neuromuscular Electrical Stimulation designed to facilitate the adoption of multiple therapeutic lifestyle behaviors associated with superior health outcomes.
干预措施: self massage (Behavioral)
Combined intervention
Combination intervention consisting of the following: structured modified paleolithic diet, Progressive Exercise, Neuromuscular Electrical Stimulation designed to facilitate the adoption of multiple therapeutic lifestyle behaviors associated with superior health outcomes.
干预措施: Progressive exercise (Other)
Combined intervention
Combination intervention consisting of the following: structured modified paleolithic diet, Progressive Exercise, Neuromuscular Electrical Stimulation designed to facilitate the adoption of multiple therapeutic lifestyle behaviors associated with superior health outcomes.
干预措施: learning (Behavioral)
Combined intervention
Combination intervention consisting of the following: structured modified paleolithic diet, Progressive Exercise, Neuromuscular Electrical Stimulation designed to facilitate the adoption of multiple therapeutic lifestyle behaviors associated with superior health outcomes.
干预措施: Neuromuscular electrical stimulation delivered using the electrical therapy device EMPI 300 PV (Device)
Combined intervention
Combination intervention consisting of the following: structured modified paleolithic diet, Progressive Exercise, Neuromuscular Electrical Stimulation designed to facilitate the adoption of multiple therapeutic lifestyle behaviors associated with superior health outcomes.
干预措施: Modified paleolithic diet (Other)
Combined intervention
Combination intervention consisting of the following: structured modified paleolithic diet, Progressive Exercise, Neuromuscular Electrical Stimulation designed to facilitate the adoption of multiple therapeutic lifestyle behaviors associated with superior health outcomes.
干预措施: Omega 3 fatty acids (Dietary Supplement)
Combined intervention
Combination intervention consisting of the following: structured modified paleolithic diet, Progressive Exercise, Neuromuscular Electrical Stimulation designed to facilitate the adoption of multiple therapeutic lifestyle behaviors associated with superior health outcomes.
干预措施: Full Spectrum vitamin (Dietary Supplement)
Combined intervention
Combination intervention consisting of the following: structured modified paleolithic diet, Progressive Exercise, Neuromuscular Electrical Stimulation designed to facilitate the adoption of multiple therapeutic lifestyle behaviors associated with superior health outcomes.
干预措施: Essential - hydroxytyrosol (Dietary Supplement)
Combined intervention
Combination intervention consisting of the following: structured modified paleolithic diet, Progressive Exercise, Neuromuscular Electrical Stimulation designed to facilitate the adoption of multiple therapeutic lifestyle behaviors associated with superior health outcomes.
干预措施: Maltodextrin fiber supplement (Dietary Supplement)
Combined intervention
Combination intervention consisting of the following: structured modified paleolithic diet, Progressive Exercise, Neuromuscular Electrical Stimulation designed to facilitate the adoption of multiple therapeutic lifestyle behaviors associated with superior health outcomes.
干预措施: Mineral boost (magnesium) (Dietary Supplement)
Combined intervention
Combination intervention consisting of the following: structured modified paleolithic diet, Progressive Exercise, Neuromuscular Electrical Stimulation designed to facilitate the adoption of multiple therapeutic lifestyle behaviors associated with superior health outcomes.
干预措施: Methyl B12 (Dietary Supplement)
Combined intervention
Combination intervention consisting of the following: structured modified paleolithic diet, Progressive Exercise, Neuromuscular Electrical Stimulation designed to facilitate the adoption of multiple therapeutic lifestyle behaviors associated with superior health outcomes.
干预措施: creatine (Dietary Supplement)
Combined intervention
Combination intervention consisting of the following: structured modified paleolithic diet, Progressive Exercise, Neuromuscular Electrical Stimulation designed to facilitate the adoption of multiple therapeutic lifestyle behaviors associated with superior health outcomes.
干预措施: thiamine (Dietary Supplement)
Combined intervention
Combination intervention consisting of the following: structured modified paleolithic diet, Progressive Exercise, Neuromuscular Electrical Stimulation designed to facilitate the adoption of multiple therapeutic lifestyle behaviors associated with superior health outcomes.
干预措施: riboflavin (Dietary Supplement)
Combined intervention
Combination intervention consisting of the following: structured modified paleolithic diet, Progressive Exercise, Neuromuscular Electrical Stimulation designed to facilitate the adoption of multiple therapeutic lifestyle behaviors associated with superior health outcomes.
干预措施: L acetyl carnitine (Dietary Supplement)
Combined intervention
Combination intervention consisting of the following: structured modified paleolithic diet, Progressive Exercise, Neuromuscular Electrical Stimulation designed to facilitate the adoption of multiple therapeutic lifestyle behaviors associated with superior health outcomes.
干预措施: methyl folate (Dietary Supplement)
Combined intervention
Combination intervention consisting of the following: structured modified paleolithic diet, Progressive Exercise, Neuromuscular Electrical Stimulation designed to facilitate the adoption of multiple therapeutic lifestyle behaviors associated with superior health outcomes.
干预措施: meditation (Behavioral)
Combined intervention
Combination intervention consisting of the following: structured modified paleolithic diet, Progressive Exercise, Neuromuscular Electrical Stimulation designed to facilitate the adoption of multiple therapeutic lifestyle behaviors associated with superior health outcomes.
干预措施: Coconut oil (Dietary Supplement)
Combined intervention
Combination intervention consisting of the following: structured modified paleolithic diet, Progressive Exercise, Neuromuscular Electrical Stimulation designed to facilitate the adoption of multiple therapeutic lifestyle behaviors associated with superior health outcomes.
干预措施: Niacinamide (Dietary Supplement)
Combined intervention
Combination intervention consisting of the following: structured modified paleolithic diet, Progressive Exercise, Neuromuscular Electrical Stimulation designed to facilitate the adoption of multiple therapeutic lifestyle behaviors associated with superior health outcomes.
干预措施: alpha lipoic acid (Dietary Supplement)
Combined intervention
Combination intervention consisting of the following: structured modified paleolithic diet, Progressive Exercise, Neuromuscular Electrical Stimulation designed to facilitate the adoption of multiple therapeutic lifestyle behaviors associated with superior health outcomes.
干预措施: coenzyme Q (Dietary Supplement)
Combined intervention
Combination intervention consisting of the following: structured modified paleolithic diet, Progressive Exercise, Neuromuscular Electrical Stimulation designed to facilitate the adoption of multiple therapeutic lifestyle behaviors associated with superior health outcomes.
干预措施: N acetylcysteine (Dietary Supplement)
Combined intervention
Combination intervention consisting of the following: structured modified paleolithic diet, Progressive Exercise, Neuromuscular Electrical Stimulation designed to facilitate the adoption of multiple therapeutic lifestyle behaviors associated with superior health outcomes.
干预措施: Taurine (Dietary Supplement)
结局指标
主要结局
Fatigue severity scale
时间窗: Baseline, 3 M, 6M, 9M,12 M
Self reported fatigue severity scale, (agreement with 9 questions describing impact of fatigue on daily activities)
次要结局
- Neurological examination(Baseline and 12 M)
- Exposure history form(Baseline)
- 25 foot walk(baseline, 3M, 6M, 9M, 12M, 18M, 24M 36M)
- Short Form 36(baseline, 3M, 6M, 9M, 12M, 18M, 24M, 36 M)
- Cognitive Scales(baseline, 3 M, 6M, 9M, 12 M)
- Medical Symptoms Questionnaire(baseline, 1 M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M, 18M, 24M, 36M)
- Side effects log(Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M)
- MS Function(Baseline, 3 M, 6M, 9M, 12M, 18M, 24M, 36M)
- Multiple Sclerosis Spasticity Scale-88(Baseline, 3M, 6M,9M and 12M, 18M, 24M, 36M)
- Peak flow(baseline, 3M, 6M, 9M, 12M)
- Number of falls in prior two months(Baseline, 3M, 6M, 9M,12M, 18M, 24M, 36M)
- Dietary compliance(Baseline, 6 month and 12 month, 36 month)
- Mood scales(Baseline, 3 M, 6M, 9M, 12M)
- Daily log(Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M)
- Vitamin log(Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M)
- Medical examination(Baseline, 12 M)
- Health questions(Baseline)
- Medication audit(Baseline, 12 M)
- Menses and pregnancy risk(Baseline, 3M, 6M, 9M, 12M)
- Manual motor testing(Baseline, 3M, 6M, 9M, 12M)
- Functional diagnoses(Baseline)
- Berg Balance(baseline, 3M, 6M, 9M, 12M)
- Modified Ashworth(baseline, 3M, 6M, 9M, 12M)
- Circumference(baseline, 3M, 6M, 9M, 12M)
- Blood pressure(baseline, 3M, 6M, 9M, 12M)
- Waist/ Hip ratio(baseline, 3M, 6M, 9M, 12M)
- MS quality of life- 54(Baseline and months 3,6,9,12,18,24,and 36)
- Change in weight and Body mass index (BMI)(Baseline, 3M, 6M, 9M, 12M, 18M, 24M, 36M)
- Blood safety biomarkers(Baseline, 1M, 3M, 6M, 9M, 12M, 18M, 24M, 36M)
- 9 hole peg board test(Baseline, 3M, 6M, 9M,12M, 18M, 24M, 36M)
- Blood Biomarkers(Baseline, 12 months)
- Fatigue severity scale(18 M, 24 M, 36 M)
- Get up and go test time(Baseline, 3M, 6M, 9M, 12M, 18M, 24M, 36M)
- Change in functional and structural brain Magnetic Resonance Imaging (MRI) measures(Between 1 and 12 month post intervention)
- Paced auditory serial addition task (PASAT)(Baseline, 3M, 6M,9M,12M, 18M,24M,36M)
- Stool microbial profile(Baseline and 12M)
- Veteran specific activity questionnaire(Baseline, 3M, 6M, 9M, 12M, 18M,24M,36M)
- Exercise and electrical stimulation daily log(Daily baseline through 12M, 14 day-logs before/after 18M, 24M and 36M)
- Form 38- Daily life(12M, 18M, 24M, 36M)
- Urine toxicology(Baseline and 12 M)
- Harvard food frequency questionnaire and 24 hour food recalls(Baseline, 12M, 24M and 36M)
- Bio impedance analysis(Baseline, 12M, 24M and 36M)
研究者
Terry L. Wahls
Clinical Professor
University of Iowa