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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01381354
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : June 26, 2018
Direct MS Canada
DJO Incorporated
Pinnaclife Inc.
TZ Press, LLC
Information provided by (Responsible Party):
Terry L. Wahls, University of Iowa

Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Progressive exercise Device: Neuromuscular electrical stimulation delivered using the electrical therapy device EMPI 300 PV Other: Modified paleolithic diet Dietary Supplement: Omega 3 fatty acids Dietary Supplement: Full Spectrum vitamin Dietary Supplement: Essential - hydroxytyrosol Dietary Supplement: Maltodextrin fiber supplement Dietary Supplement: Mineral boost (magnesium) Dietary Supplement: Niacinamide Dietary Supplement: Methyl B12 Dietary Supplement: Taurine Dietary Supplement: creatine Dietary Supplement: thiamine Dietary Supplement: riboflavin Dietary Supplement: N acetylcysteine Dietary Supplement: alpha lipoic acid Dietary Supplement: L acetyl carnitine Dietary Supplement: methyl folate Dietary Supplement: coenzyme Q Behavioral: meditation Behavioral: self massage Behavioral: learning Dietary Supplement: Coconut oil Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nutrition, Neuromuscular Electrical Stimulation (NMES) and Secondary Progressive Multiple Sclerosis (SPMS)
Study Start Date : October 2010
Actual Primary Completion Date : February 2016
Actual Study Completion Date : May 2016

Arm Intervention/treatment
Experimental: 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.
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 Name: 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 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

Primary Outcome Measures :
  1. Fatigue severity scale [ Time Frame: Baseline, 3 M, 6M, 9M,12 M ]
    Self reported fatigue severity scale, (agreement with 9 questions describing impact of fatigue on daily activities)

Secondary Outcome Measures :
  1. 25 foot walk [ Time Frame: baseline, 3M, 6M, 9M, 12M, 18M, 24M 36M ]

    Average walking speed calculated from 25 foot walk. Distance (feet)walked divided by time in seconds.

    Step and stride length, step and stride duration.

  2. Short Form 36 [ Time Frame: baseline, 3M, 6M, 9M, 12M, 18M, 24M, 36 M ]
    Self reported function in multiple domains.

  3. Mood scales [ Time Frame: Baseline, 3 M, 6M, 9M, 12M ]
    Beck depression index, Beck anxiety index

  4. Cognitive Scales [ Time Frame: baseline, 3 M, 6M, 9M, 12 M ]
    Cognitive stability index or cognitive stability test, subscales of Dkef, Wtar, Wais III.

  5. Medical Symptoms Questionnaire [ Time Frame: baseline, 1 M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M, 18M, 24M, 36M ]
    Detailed review of systems which is scored 0 to 4 for each item.

  6. Side effects log [ Time Frame: Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M ]
    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.

  7. MS Function [ Time Frame: Baseline, 3 M, 6M, 9M, 12M, 18M, 24M, 36M ]
    Self reported disability scales (from North American Research committee on Multiple Sclerosis)

  8. Multiple Sclerosis Spasticity Scale-88 [ Time Frame: Baseline, 3M, 6M,9M and 12M, 18M, 24M, 36M ]
    88 Questions about the impact of spasticity on various activities of daily living

  9. Daily log [ Time Frame: Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M ]
    Daily reports of foods consumed, exercises and activities completed.

  10. Vitamin log [ Time Frame: Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M ]
    Log of vitamins supplement bottles date opened, date emptied, pill size, number of pills in bottle.

  11. Medical examination [ Time Frame: Baseline, 12 M ]
    Medical examination

  12. Neurological examination [ Time Frame: Baseline and 12 M ]
    Neurological examination

  13. Exposure history form [ Time Frame: Baseline ]
    History of exposures to chemicals.

  14. Health questions [ Time Frame: Baseline ]
    health questions about chronic disease states

  15. Menses and pregnancy risk [ Time Frame: Baseline, 3M, 6M, 9M, 12M ]
    Questions about menses and potential for pregnancy

  16. Medication audit [ Time Frame: Baseline, 12 M ]

  17. Functional diagnoses [ Time Frame: Baseline ]
    Questions about past medical history

  18. Manual motor testing [ Time Frame: Baseline, 3M, 6M, 9M, 12M ]
    Manual motor testing of arms, legs and core muscle groups.

  19. Berg Balance [ Time Frame: baseline, 3M, 6M, 9M, 12M ]
    Tests of balance which are progressively more challenging.

  20. Modified Ashworth [ Time Frame: baseline, 3M, 6M, 9M, 12M ]
    Test of spasticity by physical examination.

  21. Circumference [ Time Frame: baseline, 3M, 6M, 9M, 12M ]
    Circ. of waist, hips, R and+ L calf and R. and L. thigh.

  22. Peak flow [ Time Frame: baseline, 3M, 6M, 9M, 12M ]
    Peak expiratory flow rate.

  23. Number of falls in prior two months [ Time Frame: Baseline, 3M, 6M, 9M,12M, 18M, 24M, 36M ]
    Self reported number of falls and associated factors contributing to fall and severity of fall related injuries.

  24. Dietary compliance [ Time Frame: Baseline, 6 month and 12 month, 36 month ]
    Assessments, self report, Harvard Food Frequency (baseline, 12 month), 24 hour dietary recalls (6M)

  25. Blood pressure [ Time Frame: baseline, 3M, 6M, 9M, 12M ]
    blood pressure

  26. Waist/ Hip ratio [ Time Frame: baseline, 3M, 6M, 9M, 12M ]
    circumference of waist over the circumference of hip

  27. MS quality of life- 54 [ Time Frame: Baseline and months 3,6,9,12,18,24,and 36 ]
    Quality of life questionnaires asking about various aspects of daily life.

  28. Blood Biomarkers [ Time Frame: Baseline, 12 months ]
    Blood biomarkers of inflammation, and nutritional status.

  29. Change in functional and structural brain Magnetic Resonance Imaging (MRI) measures [ Time Frame: Between 1 and 12 month post intervention ]

    Following sequences:

    T1 weighted - Pre Gadolinium T1 weighted -Post Gadolinium T2 weighted FLAIR functional MRI during cognitive task Resting state functional MRI Diffusion Tensor Imaging

  30. Fatigue severity scale [ Time Frame: 18 M, 24 M, 36 M ]
    Self reported fatigue severity scale, (agreement with 9 questions describing impact of fatigue on daily activities)

  31. Get up and go test time [ Time Frame: Baseline, 3M, 6M, 9M, 12M, 18M, 24M, 36M ]

    Total time to get up from chair, walk 10 feet and come back and sit down on the chair.

    Step and stride length, step and stride duration and double support time.

  32. Change in weight and Body mass index (BMI) [ Time Frame: Baseline, 3M, 6M, 9M, 12M, 18M, 24M, 36M ]
    weight measured in Kg Body mass index (BMI)

  33. Blood safety biomarkers [ Time Frame: Baseline, 1M, 3M, 6M, 9M, 12M, 18M, 24M, 36M ]
    Kidney and liver function tests and complete blood count

  34. 9 hole peg board test [ Time Frame: Baseline, 3M, 6M, 9M,12M, 18M, 24M, 36M ]
    Time to put 9 pegs in holes and take them out.

  35. Paced auditory serial addition task (PASAT) [ Time Frame: Baseline, 3M, 6M,9M,12M, 18M,24M,36M ]
    Addition of two consecutive numbers during a series of numbers heard by subject.

  36. Veteran specific activity questionnaire [ Time Frame: Baseline, 3M, 6M, 9M, 12M, 18M,24M,36M ]
    Questions about the maximum physical activity level.

  37. Form 38- Daily life [ Time Frame: 12M, 18M, 24M, 36M ]
    Questions about stressful life events.

  38. Urine toxicology [ Time Frame: Baseline and 12 M ]
    24 hours urine collection and measurement of heavy metals.

  39. Stool microbial profile [ Time Frame: Baseline and 12M ]
    DNA probe for bacteria, parasites and yeast DNA.

  40. Harvard food frequency questionnaire and 24 hour food recalls [ Time Frame: Baseline, 12M, 24M and 36M ]

    Questions regarding food intake and frequency of type of food consumed in last one year.

    Phone interview asking about food consumed in last 24 hours.

  41. Bio impedance analysis [ Time Frame: Baseline, 12M, 24M and 36M ]
    Test to analyze body composition.

  42. Exercise and electrical stimulation daily log [ Time Frame: Daily baseline through 12M, 14 day-logs before/after 18M, 24M and 36M ]
    Record of exercise, use of electrical stimulation on muscles and physical activity.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01381354

Layout table for location information
United States, Iowa
Univeristy of Iowa/ VA Iowa City VA Medical Center
Iowa City, Iowa, United States, 52246
Sponsors and Collaborators
University of Iowa
Direct MS Canada
DJO Incorporated
Pinnaclife Inc.
TZ Press, LLC
Layout table for additonal information
Responsible Party: Terry L. Wahls, Clinical Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01381354    
Other Study ID Numbers: 200911781
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Keywords provided by Terry L. Wahls, University of Iowa:
Secondary Progressive Multiple Sclerosis, primary progressive multiple sclerosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Chronic Disease
Disease Attributes
Thioctic Acid
Nicotinic Acids
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents