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

• Fatigue Severity Scale [ Time Frame: baseline, 3M, 6M, 9M, 12M ] [ Designated as safety issue: No ]
  Self reported fatigue severity scale, (agreement with 9 questions describing impact of fatigue on daily activities)
• Short Form 36 [ Time Frame: baseline, 3M, 6M, 9M, 12M ] [ Designated as safety issue: No ]
  Self reported function in multiple domains.
• Mood scales [ Time Frame: Baseline, 3 M, 6M, 9M, 12M ] [ Designated as safety issue: No ]
  Beck depression index, Beck anxiety index
• Cognitive Scales [ Time Frame: baseline, 3 M, 6M, 9M, end of study ] [ Designated as safety issue: No ]
  Cognitive stability index or cognitive stability test, subscales of Dkef, Wtar, Wais III.
• Medical Symptoms Questionnaire [ Time Frame: baseline, 1 M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M ] [ Designated as safety issue: No ]
  Detailed review of systems which is scored 0 to 4 for each item.
• Side effects log [ Time Frame: Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M ] [ Designated as safety issue: Yes ]
  Questions about potential side effects from vitamin, supplements and diet, questions about potential side effects from NMES, and questions about potential side effects from exercise.
• MS Function [ Time Frame: Baseline, 3 M, 6M, 9M, 12M ] [ Designated as safety issue: No ]
  Self reported disability scales (from North American Research committe on Multiple Sclerosis)
• MSSS-88 [ Time Frame: Baseline, 3M, 6M,9M and 12M ] [ Designated as safety issue: No ]
  88 Questions about the impact of spasticity on various activities of daily living
• Daily log [ Time Frame: Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M ] [ Designated as safety issue: No ]
  Daily reports of foods consumed, exercises and activities completed.
• Vitamin log [ Time Frame: Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M ] [ Designated as safety issue: No ]
  Log of vitamins supplement bottles date opened, date emptied, pill size, number of pills in bottle.
• Medical examination [ Time Frame: Baseline, 12 M ] [ Designated as safety issue: Yes ]
  Medical examination
• Neurological examination [ Time Frame: Baseline and 12 M ] [ Designated as safety issue: No ]
  Neurological examination
• Exposure history form [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  History of exposures to chemicals.
• Health questions [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  health questions about chronic disease states
• Menses and pregnancy risk [ Time Frame: Baseline, 3M, 6M, 9M, 12M ] [ Designated as safety issue: Yes ]
  Questions about menses and potential for pregnancy
• Medication audit [ Time Frame: Baseline, 12 M ] [ Designated as safety issue: Yes ]
  Medications
• Functional diagnoses [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  Questions about past medical history
• Manual motor testing [ Time Frame: Baseline, 3M, 6M, 9M, 12M ] [ Designated as safety issue: No ]
  Manual motor testing of arms, legs and core muscle groups.
• Berg Balance [ Time Frame: baseline, 3M, 6M, 9M, 12M ] [ Designated as safety issue: No ]
  Tests of balance which are progressively more challenging.
• Modified Ashworth [ Time Frame: baseline, 3M, 6M, 9M, 12M ] [ Designated as safety issue: No ]
  Test of spasticity by physical examination.
• Circumference [ Time Frame: baseline, 3M, 6M, 9M, 12M ] [ Designated as safety issue: No ]
  Circ. of waist, hips, R and+ L calf and R. and L. thigh.
• Peak flow [ Time Frame: basaeline, 3M, 6M, 9M, 12M ] [ Designated as safety issue: No ]
  Peak expiratory flow rate.
• Number of falls in prior two months [ Time Frame: Baseline, 3M, 6M, 9M and 12M ] [ Designated as safety issue: No ]
  Self reported number of falls and associated factors contributing to fall and severity of fall related injuries.
• Dietary compliance [ Time Frame: Baseline, 6 month and 12 month ] [ Designated as safety issue: No ]
  Assessments, self report, Harvard Food Frequency (baseline, 12 month), 24 hour dietary recalls (6M)
• Blood pressure [ Time Frame: baseline, 3M, 6M, 9M, 12M ] [ Designated as safety issue: No ]
  blood pressure
• Waist/ Hip ratio [ Time Frame: baseline, 3M, 6M, 9M, 12M ] [ Designated as safety issue: No ]
  circumference of waist over the circumference of hip

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 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 at reducing oxidative stress and increasing the organic sulfur in the diet. Multiple studies of neuromuscular electrical stimulation in athletes, cerebral palsy and stroke patients have demonstrated gains in strength, coordination and diminished resting muscle tone. 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.

• Other: Progressive exercise
  Strength and endurance 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 PV manufactured by DJO Inc.
  Other Name: NMES, electrical therapy
• Other: Wahls 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 Name: Wahls Diet, Paleolithic Diet, Gluten-free, Dairy-free.
• Dietary Supplement: Omega 3 fatty acids
  4 grams daily by mouth.
  Other Name: Pinnaclife Omega 3 fatty acids
• Dietary Supplement: Full Spectrum vitamin
  Two capsules daily.
  Other Name: Pinnaclife
• Dietary Supplement: Essential - hydroxytyrosol
  Two capsules twice daily.
  Other Name: Pinnaclife Essential
• Dietary Supplement: Maltodextrin fiber supplement
  One scoop daily.
  Other Name: Pinnaclife Cleanse
• Dietary Supplement: Mineral boost (magnesium)
  Two capsules daily
  Other Name: 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: 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.
  Other Name: Extra virgin cold press coconut oil

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)

• Direct MS Canada
• DJO Incorporated
• Pinnaclife Inc.
• TZ Press, LLC