NCT01381354

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	Progressive exercise	Progressive strengthening exercises designed to improve core muscles and muscles of ambulation.
DEVICE	Neuromuscular electrical stimulation delivered using the electrical therapy device EMPI 300 PV	Neuromuscular electrical stimulation to train core muscles and ambulation muscles. Device is Empi 300 manufactured by DJO Inc.
OTHER	Modified paleolithic diet	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.
DIETARY_SUPPLEMENT	Omega 3 fatty acids	4 grams daily by mouth.
DIETARY_SUPPLEMENT	Full Spectrum vitamin	Two capsules daily.
DIETARY_SUPPLEMENT	Essential - hydroxytyrosol	Two capsules twice daily.
DIETARY_SUPPLEMENT	Maltodextrin fiber supplement	One scoop daily.
DIETARY_SUPPLEMENT	Mineral boost (magnesium)	Two capsules daily
DIETARY_SUPPLEMENT	Niacinamide	500 mg daily
DIETARY_SUPPLEMENT	Methyl B12	Methyl B12 1000 mcg daily
DIETARY_SUPPLEMENT	Taurine	one gram daily
DIETARY_SUPPLEMENT	creatine	one teaspoon daily
DIETARY_SUPPLEMENT	thiamine	100 mg daily
DIETARY_SUPPLEMENT	riboflavin	200 mg daily
DIETARY_SUPPLEMENT	N acetylcysteine	1 gram daily
DIETARY_SUPPLEMENT	alpha lipoic acid	300 mg twice daily
DIETARY_SUPPLEMENT	L acetyl carnitine	500 mg twice daily
DIETARY_SUPPLEMENT	methyl folate	1000 mcg one pill four times a week
DIETARY_SUPPLEMENT	coenzyme Q	100 mg daily
BEHAVIORAL	meditation	meditation 15 minutes daily
BEHAVIORAL	self massage	self massage of hands, feet, ears 15 minutes daily
BEHAVIORAL	learning	completing puzzles or learning 15 minutes daily
DIETARY_SUPPLEMENT	Coconut oil	If excessive weight loss occurs, the subject will add 1-2 tablespoons of coconut oil daily to smoothies or foods eaten.

Timeline

• Start date: 2010-10-01
• Primary completion: 2016-02-01
• Completion: 2016-05-01
• First posted: 2011-06-27
• Last updated: 2018-06-26

Locations

1 site across 1 country: United States