Nutrition, Neuromuscular Electrical Stimulation (NMES) and Secondary Progressive Multiple Sclerosis (SPMS)
NCT ID: NCT01381354
Last Updated: 2018-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
38 participants
INTERVENTIONAL
2010-10-31
2016-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Combined intervention
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
Neuromuscular electrical stimulation to train core muscles and ambulation muscles. Device is Empi 300 manufactured by DJO Inc.
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.
Omega 3 fatty acids
4 grams daily by mouth.
Full Spectrum vitamin
Two capsules daily.
Essential - hydroxytyrosol
Two capsules twice daily.
Maltodextrin fiber supplement
One scoop daily.
Mineral boost (magnesium)
Two capsules daily
Niacinamide
500 mg daily
Methyl B12
Methyl B12 1000 mcg daily
Taurine
one gram daily
creatine
one teaspoon daily
thiamine
100 mg daily
riboflavin
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
meditation 15 minutes daily
self massage
self massage of hands, feet, ears 15 minutes daily
learning
completing puzzles or learning 15 minutes daily
Coconut oil
If excessive weight loss occurs, the subject will add 1-2 tablespoons of coconut oil daily to smoothies or foods eaten.
Interventions
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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
Neuromuscular electrical stimulation to train core muscles and ambulation muscles. Device is Empi 300 manufactured by DJO Inc.
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.
Omega 3 fatty acids
4 grams daily by mouth.
Full Spectrum vitamin
Two capsules daily.
Essential - hydroxytyrosol
Two capsules twice daily.
Maltodextrin fiber supplement
One scoop daily.
Mineral boost (magnesium)
Two capsules daily
Niacinamide
500 mg daily
Methyl B12
Methyl B12 1000 mcg daily
Taurine
one gram daily
creatine
one teaspoon daily
thiamine
100 mg daily
riboflavin
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
meditation 15 minutes daily
self massage
self massage of hands, feet, ears 15 minutes daily
learning
completing puzzles or learning 15 minutes daily
Coconut oil
If excessive weight loss occurs, the subject will add 1-2 tablespoons of coconut oil daily to smoothies or foods eaten.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Cognitive disability or psychiatric disorder making compliance with study interventions difficult
* Implanted electronic medical device
* Change in medication in the prior three months
18 Years
65 Years
ALL
No
Sponsors
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Direct MS Canada
UNKNOWN
DJO Incorporated
INDUSTRY
Pinnaclife Inc.
INDUSTRY
TZ Press, LLC
UNKNOWN
University of Iowa
OTHER
Responsible Party
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Terry L. Wahls
Clinical Professor
Locations
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Univeristy of Iowa/ VA Iowa City VA Medical Center
Iowa City, Iowa, United States
Countries
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References
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Wahls TL, Reese D, Kaplan D, Darling WG. Rehabilitation with neuromuscular electrical stimulation leads to functional gains in ambulation in patients with secondary progressive and primary progressive multiple sclerosis: a case series report. J Altern Complement Med. 2010 Dec;16(12):1343-9. doi: 10.1089/acm.2010.0080.
Reese D, Shivapour ET, Wahls TL, Dudley-Javoroski SD, Shields R. Neuromuscular electrical stimulation and dietary interventions to reduce oxidative stress in a secondary progressive multiple sclerosis patient leads to marked gains in function: a case report. Cases J. 2009 Aug 10;2:7601. doi: 10.4076/1757-1626-2-7601.
Other Identifiers
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200911781
Identifier Type: -
Identifier Source: org_study_id
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