Official Title
Nutrition, Neuromuscular Electrical Stimulation (NMES) and Secondary Progressive Multiple Sclerosis (SPMS)
Phase
Phase 1Lead Sponsor
University of IowaStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Multiple SclerosisIntervention/Treatment
maltodextrin acetylcarnitine hydroxytyrosol magnesium oxide multivitamins methylfolate ...Study Participants
38The 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.
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.
500 mg daily
Two capsules daily
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.
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.
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.
Inclusion Criteria: 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 Exclusion Criteria: 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)
