Nutrition, Neuromuscular Electrical Stimulation (NMES) and Secondary Progressive Multiple Sclerosis (SPMS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.

      To assess for safety we will assess safety labs (kidney and liver function tests) and changes
      in weight, and self reported side effects questionnaire.
    

Intervention name(s): Progressive exercise; Neuromuscular electrical stimulation delivered using the electrical therapy device EMPI 300 PV; Modified paleolithic diet; Omega 3 fatty acids; Full Spectrum vitamin; Essential - hydroxytyrosol; Maltodextrin fiber supplement; Mineral boost (magnesium); Niacinamide; Methyl B12; Taurine; creatine; thiamine; riboflavin; N acetylcysteine; alpha lipoic acid; L acetyl carnitine; methyl folate; coenzyme Q; meditation; self massage; learning; Coconut oil
Intervention type(s): Other; Device; Other; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Behavioral; Behavioral; Behavioral; Dietary Supplement
Intervention description(s): Progressive strengthening exercises designed to improve core muscles and muscles of ambulation.; Neuromuscular electrical stimulation to train core muscles and ambulation muscles. Device is Empi 300 manufactured by DJO Inc.; Diet based upon a Paleolithic diet and structured to increase the consumption of greens, sulfur rich vegetables, bright colors, seaweed and omega 3 fatty acid rich foods.; 4 grams daily by mouth.; Two capsules daily.; Two capsules twice daily.; One scoop daily.; Two capsules daily; 500 mg daily; Methyl B12 1000 mcg daily; one gram daily; one teaspoon daily; 100 mg daily; 200 mg daily; 1 gram daily; 300 mg twice daily; 500 mg twice daily; 1000 mcg one pill four times a week; 100 mg daily; meditation 15 minutes daily; self massage of hands, feet, ears 15 minutes daily; completing puzzles or learning 15 minutes daily; If excessive weight loss occurs, the subject will add 1-2 tablespoons of coconut oil daily to smoothies or foods eaten.
Other intervention name(s): NMES, electrical therapy; Wahls Diet, Paleolithic Diet, Gluten-free, Dairy-free.; Pinnaclife Omega 3 fatty acids; Pinnaclife; Pinnaclife Essential; Pinnaclife Cleanse; Pinnaclife Mineral Boost.; Extra virgin cold press coconut oil
Intervention MeSH terms: Thioctic Acid; Riboflavin; Thiamine; Niacinamide; Niacin; Nicotinic Acids; Acetylcarnitine; Ubiquinone; Acetylcysteine; 3,4-dihydroxyphenylethanol; N-monoacetylcystine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Secondary Progressive Multiple Sclerosis, primary progressive multiple sclerosis