Official Title

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

    Phase 1
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    maltodextrin acetylcarnitine hydroxytyrosol magnesium oxide multivitamins methylfolate ...
  • Study Participants

    38
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.
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.
Study Started
Oct 31
2010
Primary Completion
Feb 29
2016
Study Completion
May 31
2016
Last Update
Jun 26
2018

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 names: NMES, electrical therapy

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.

  • Other names: Wahls Diet, Paleolithic Diet, Gluten-free, Dairy-free.

Dietary Supplement Omega 3 fatty acids

4 grams daily by mouth.

  • Other names: Pinnaclife Omega 3 fatty acids

Dietary Supplement Full Spectrum vitamin

Two capsules daily.

  • Other names: Pinnaclife

Dietary Supplement Essential - hydroxytyrosol

Two capsules twice daily.

  • Other names: Pinnaclife Essential

Dietary Supplement Maltodextrin fiber supplement

One scoop daily.

  • Other names: Pinnaclife Cleanse

Dietary Supplement alpha lipoic acid

300 mg twice daily

Dietary Supplement Mineral boost (magnesium)

Two capsules daily

  • Other names: Pinnaclife Mineral Boost.

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 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.

  • Other names: Extra virgin cold press coconut oil

Combined intervention Experimental

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.

Criteria

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)
No Results Posted