Nutrition, Neuromuscular Electrical Stimulation (NMES) and Secondary Progressive Multiple Sclerosis (SPMS)

University of Iowa

Status and phase: Completed; Phase 1

Conditions: Multiple Sclerosis

Treatments: Behavioral: self massage; Dietary Supplement: Taurine; Dietary Supplement: Maltodextrin fiber supplement; Behavioral: meditation; Dietary Supplement: Mineral boost (magnesium); Dietary Supplement: coenzyme Q; Dietary Supplement: N acetylcysteine; Dietary Supplement: Niacinamide; Dietary Supplement: methyl folate; Device: Neuromuscular electrical stimulation delivered using the electrical therapy device EMPI 300 PV; Dietary Supplement: creatine; Dietary Supplement: Full Spectrum vitamin; Dietary Supplement: Methyl B12; Dietary Supplement: Essential - hydroxytyrosol; Dietary Supplement: riboflavin; Dietary Supplement: thiamine; Dietary Supplement: Coconut oil; Behavioral: learning; Dietary Supplement: alpha lipoic acid; Dietary Supplement: L acetyl carnitine; Dietary Supplement: Omega 3 fatty acids; Other: Progressive exercise; Other: Modified paleolithic diet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01381354

200911781

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Combined intervention

Experimental group

Description:

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.

Treatment:

Dietary Supplement: riboflavin

Other: Modified paleolithic diet

Dietary Supplement: alpha lipoic acid

Dietary Supplement: Omega 3 fatty acids

Behavioral: meditation

Dietary Supplement: Niacinamide

Dietary Supplement: Coconut oil

Other: Progressive exercise

Dietary Supplement: Essential - hydroxytyrosol

Dietary Supplement: Full Spectrum vitamin

Device: Neuromuscular electrical stimulation delivered using the electrical therapy device EMPI 300 PV

Behavioral: self massage

Dietary Supplement: Taurine

Dietary Supplement: coenzyme Q

Dietary Supplement: Methyl B12

Dietary Supplement: methyl folate

Dietary Supplement: creatine

Dietary Supplement: thiamine

Dietary Supplement: N acetylcysteine

Dietary Supplement: Mineral boost (magnesium)

Dietary Supplement: L acetyl carnitine

Behavioral: learning

Dietary Supplement: Maltodextrin fiber supplement