This trial is active, not recruiting.

Condition multiple sclerosis
Treatments progressive exercise, neuromuscular electrical stimulation delivered using the electrical therapy device empi 300 pv, modified paleolithic diet, omega 3 fatty acids, full spectrum vitamin, essential - hydroxytyrosol, maltodextrin fiber supplement, mineral boost (magnesium), niacinamide, methyl b12, taurine, creatine, thiamine, riboflavin, n acetylcysteine, alpha lipoic acid, l acetyl carnitine, methyl folate, coenzyme q, meditation, self massage, learning, coconut oil
Phase phase 1
Sponsor University of Iowa
Collaborator Direct MS Canada
Start date October 2010
End date February 2016
Trial size 40 participants
Trial identifier NCT01381354, 200911781


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.
progressive exercise
Progressive strengthening exercises designed to improve core muscles and muscles of ambulation.
neuromuscular electrical stimulation delivered using the electrical therapy device empi 300 pv NMES, electrical therapy
Neuromuscular electrical stimulation to train core muscles and ambulation muscles. Device is Empi 300 manufactured by DJO Inc.
modified paleolithic diet Wahls Diet, Paleolithic Diet, Gluten-free, Dairy-free.
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.
omega 3 fatty acids Pinnaclife Omega 3 fatty acids
4 grams daily by mouth.
full spectrum vitamin Pinnaclife
Two capsules daily.
essential - hydroxytyrosol Pinnaclife Essential
Two capsules twice daily.
maltodextrin fiber supplement Pinnaclife Cleanse
One scoop daily.
mineral boost (magnesium) Pinnaclife Mineral Boost.
Two capsules daily
500 mg daily
methyl b12
Methyl B12 1000 mcg daily
one gram daily
one teaspoon daily
100 mg daily
200 mg daily
n acetylcysteine
1 gram daily
alpha lipoic acid
300 mg twice daily
l acetyl carnitine
500 mg twice daily
methyl folate
1000 mcg one pill four times a week
coenzyme q
100 mg daily
meditation 15 minutes daily
self massage
self massage of hands, feet, ears 15 minutes daily
completing puzzles or learning 15 minutes daily
coconut oil Extra virgin cold press coconut oil
If excessive weight loss occurs, the subject will add 1-2 tablespoons of coconut oil daily to smoothies or foods eaten.

Primary Outcomes

Fatigue severity scale
time frame: Baseline, 3 M, 6M, 9M,12 M

Secondary Outcomes

25 foot walk
time frame: baseline, 3M, 6M, 9M, 12M, 18M, 24M 36M
Short Form 36
time frame: baseline, 3M, 6M, 9M, 12M, 18M, 24M, 36 M
Mood scales
time frame: Baseline, 3 M, 6M, 9M, 12M
Cognitive Scales
time frame: baseline, 3 M, 6M, 9M, 12 M
Medical Symptoms Questionnaire
time frame: baseline, 1 M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M, 18M, 24M, 36M
Side effects log
time frame: Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M
MS Function
time frame: Baseline, 3 M, 6M, 9M, 12M, 18M, 24M, 36M
Multiple Sclerosis Spasticity Scale-88
time frame: Baseline, 3M, 6M,9M and 12M, 18M, 24M, 36M
Daily log
time frame: Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M
Vitamin log
time frame: Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M
Medical examination
time frame: Baseline, 12 M
Neurological examination
time frame: Baseline and 12 M
Exposure history form
time frame: Baseline
Health questions
time frame: Baseline
Menses and pregnancy risk
time frame: Baseline, 3M, 6M, 9M, 12M
Medication audit
time frame: Baseline, 12 M
Functional diagnoses
time frame: Baseline
Manual motor testing
time frame: Baseline, 3M, 6M, 9M, 12M
Berg Balance
time frame: baseline, 3M, 6M, 9M, 12M
Modified Ashworth
time frame: baseline, 3M, 6M, 9M, 12M
time frame: baseline, 3M, 6M, 9M, 12M
Peak flow
time frame: basaeline, 3M, 6M, 9M, 12M
Number of falls in prior two months
time frame: Baseline, 3M, 6M, 9M,12M, 18M, 24M, 36M
Dietary compliance
time frame: Baseline, 6 month and 12 month, 36 month
Blood pressure
time frame: baseline, 3M, 6M, 9M, 12M
Waist/ Hip ratio
time frame: baseline, 3M, 6M, 9M, 12M
MS quality of life- 54
time frame: Baseline and months 3,6,9,12,18,24,and 36
Blood Biomarkers
time frame: Baseline, 12 months
Change in functional and structural brain Magnetic Resonance Imaging (MRI) measures
time frame: Between 1 and 12 month post intervention
Fatigue severity scale
time frame: 18 M, 24 M, 36 M
Get up and go test time
time frame: Baseline, 3M, 6M, 9M, 12M, 18M, 24M, 36M
Change in weight and Body mass index (BMI)
time frame: Baseline, 3M, 6M, 9M, 12M, 18M, 24M, 36M
Blood safety biomarkers
time frame: Baseline, 1M, 3M, 6M, 9M, 12M, 18M, 24M, 36M
9 hole peg board test
time frame: Baseline, 3M, 6M, 9M,12M, 18M, 24M, 36M
Paced auditory serial addition task (PASAT)
time frame: Baseline, 3M, 6M,9M,12M, 18M,24M,36M
Veteran specific activity questionnaire
time frame: Baseline, 3M, 6M, 9M, 12M, 18M,24M,36M
Form 38- Daily life
time frame: 12M, 18M, 24M, 36M
Urine toxicology
time frame: Baseline and 12 M
Stool microbial profile
time frame: Baseline and 12M
Harvard food frequency questionnaire and 24 hour food recalls
time frame: Baseline, 12M, 24M and 36M
Bio impedance analysis
time frame: Baseline, 12M, 24M and 36M
Exercise and electrical stimulation daily log
time frame: Daily baseline through 12M, 14 day-logs before/after 18M, 24M and 36M

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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)

Additional Information

Official title Nutrition, Neuromuscular Electrical Stimulation (NMES) and Secondary Progressive Multiple Sclerosis (SPMS)
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of Iowa.