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Trial record 1 of 1 for:    Nutrition, Neuromuscular Electrical Stimulation (NMES) and Secondary Progressive Multiple Sclerosis (SPMS)Nutrition, Neuromuscular Electrical Stimulation (NMES) and Secondary Progressive Multiple Sclerosis (SPMS)
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Nutrition, Neuromuscular Electrical Stimulation (NMES) and Secondary Progressive Multiple Sclerosis (SPMS)

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ClinicalTrials.gov Identifier: NCT01381354
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : June 26, 2018
Sponsor:
Collaborators:
Direct MS Canada
DJO Incorporated
Pinnaclife Inc.
TZ Press, LLC
Information provided by (Responsible Party):
Terry L. Wahls, University of Iowa

Tracking Information
First Submitted Date  ICMJE May 26, 2011
First Posted Date  ICMJE June 27, 2011
Last Update Posted Date June 26, 2018
Study Start Date  ICMJE October 2010
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2014)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: June 24, 2011)
Average walking speed [ Time Frame: Baseline, 12 M ]
Average walking speed calculated from 25 foot walk. Distance (feet)walked divided by time in seconds.
Change History Complete list of historical versions of study NCT01381354 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2016)
  • 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.
  • Short Form 36 [ Time Frame: baseline, 3M, 6M, 9M, 12M, 18M, 24M, 36 M ]
    Self reported function in multiple domains.
  • Mood scales [ Time Frame: Baseline, 3 M, 6M, 9M, 12M ]
    Beck depression index, Beck anxiety index
  • Cognitive Scales [ Time Frame: baseline, 3 M, 6M, 9M, 12 M ]
    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, 18M, 24M, 36M ]
    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 ]
    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, 18M, 24M, 36M ]
    Self reported disability scales (from North American Research committee on Multiple Sclerosis)
  • 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
  • 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.
  • 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.
  • Medical examination [ Time Frame: Baseline, 12 M ]
    Medical examination
  • Neurological examination [ Time Frame: Baseline and 12 M ]
    Neurological examination
  • Exposure history form [ Time Frame: Baseline ]
    History of exposures to chemicals.
  • Health questions [ Time Frame: Baseline ]
    health questions about chronic disease states
  • Menses and pregnancy risk [ Time Frame: Baseline, 3M, 6M, 9M, 12M ]
    Questions about menses and potential for pregnancy
  • Medication audit [ Time Frame: Baseline, 12 M ]
    Medications
  • Functional diagnoses [ Time Frame: Baseline ]
    Questions about past medical history
  • Manual motor testing [ Time Frame: Baseline, 3M, 6M, 9M, 12M ]
    Manual motor testing of arms, legs and core muscle groups.
  • Berg Balance [ Time Frame: baseline, 3M, 6M, 9M, 12M ]
    Tests of balance which are progressively more challenging.
  • Modified Ashworth [ Time Frame: baseline, 3M, 6M, 9M, 12M ]
    Test of spasticity by physical examination.
  • Circumference [ Time Frame: baseline, 3M, 6M, 9M, 12M ]
    Circ. of waist, hips, R and+ L calf and R. and L. thigh.
  • Peak flow [ Time Frame: baseline, 3M, 6M, 9M, 12M ]
    Peak expiratory flow rate.
  • 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.
  • 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)
  • Blood pressure [ Time Frame: baseline, 3M, 6M, 9M, 12M ]
    blood pressure
  • Waist/ Hip ratio [ Time Frame: baseline, 3M, 6M, 9M, 12M ]
    circumference of waist over the circumference of hip
  • 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.
  • Blood Biomarkers [ Time Frame: Baseline, 12 months ]
    Blood biomarkers of inflammation, and nutritional status.
  • 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
  • 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)
  • 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.
  • 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)
  • Blood safety biomarkers [ Time Frame: Baseline, 1M, 3M, 6M, 9M, 12M, 18M, 24M, 36M ]
    Kidney and liver function tests and complete blood count
  • 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.
  • 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.
  • Veteran specific activity questionnaire [ Time Frame: Baseline, 3M, 6M, 9M, 12M, 18M,24M,36M ]
    Questions about the maximum physical activity level.
  • Form 38- Daily life [ Time Frame: 12M, 18M, 24M, 36M ]
    Questions about stressful life events.
  • Urine toxicology [ Time Frame: Baseline and 12 M ]
    24 hours urine collection and measurement of heavy metals.
  • Stool microbial profile [ Time Frame: Baseline and 12M ]
    DNA probe for bacteria, parasites and yeast DNA.
  • 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.
  • Bio impedance analysis [ Time Frame: Baseline, 12M, 24M and 36M ]
    Test to analyze body composition.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2011)
  • Fatigue severity scale [ Time Frame: baseline, 3M, 6M, 9M, 12M ]
    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 ]
    Self reported function in multiple domains.
  • Mood scales [ Time Frame: Baseline, 3 M, 6M, 9M, 12M ]
    Beck depression index, Beck anxiety index
  • Cognitive Scales [ Time Frame: baseline, 3 M, 6M, 9M, end of study ]
    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 ]
    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 ]
    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 ]
    Self reported disability scales (from North American Research committe on Multiple Sclerosis)
  • MSSS-88 [ Time Frame: Baseline, 3M, 6M,9M and 12M ]
    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 ]
    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 ]
    Log of vitamins supplement bottles date opened, date emptied, pill size, number of pills in bottle.
  • Medical examination [ Time Frame: Baseline, 12 M ]
    Medical examination
  • Neurological examination [ Time Frame: Baseline and 12 M ]
    Neurological examination
  • Exposure history form [ Time Frame: Baseline ]
    History of exposures to chemicals.
  • Health questions [ Time Frame: Baseline ]
    health questions about chronic disease states
  • Menses and pregnancy risk [ Time Frame: Baseline, 3M, 6M, 9M, 12M ]
    Questions about menses and potential for pregnancy
  • Medication audit [ Time Frame: Baseline, 12 M ]
    Medications
  • Functional diagnoses [ Time Frame: Baseline ]
    Questions about past medical history
  • Manual motor testing [ Time Frame: Baseline, 3M, 6M, 9M, 12M ]
    Manual motor testing of arms, legs and core muscle groups.
  • Berg Balance [ Time Frame: baseline, 3M, 6M, 9M, 12M ]
    Tests of balance which are progressively more challenging.
  • Modified Ashworth [ Time Frame: baseline, 3M, 6M, 9M, 12M ]
    Test of spasticity by physical examination.
  • Circumference [ Time Frame: baseline, 3M, 6M, 9M, 12M ]
    Circ. of waist, hips, R and+ L calf and R. and L. thigh.
  • Peak flow [ Time Frame: basaeline, 3M, 6M, 9M, 12M ]
    Peak expiratory flow rate.
  • Number of falls in prior two months [ Time Frame: Baseline, 3M, 6M, 9M and 12M ]
    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 ]
    Assessments, self report, Harvard Food Frequency (baseline, 12 month), 24 hour dietary recalls (6M)
  • Blood pressure [ Time Frame: baseline, 3M, 6M, 9M, 12M ]
    blood pressure
  • Waist/ Hip ratio [ Time Frame: baseline, 3M, 6M, 9M, 12M ]
    circumference of waist over the circumference of hip
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nutrition, Neuromuscular Electrical Stimulation (NMES) and Secondary Progressive Multiple Sclerosis (SPMS)
Official Title  ICMJE Nutrition, Neuromuscular Electrical Stimulation (NMES) and Secondary Progressive Multiple Sclerosis (SPMS)
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 22, 2016)
38
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2011)
35
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01381354
Other Study ID Numbers  ICMJE 200911781
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Terry L. Wahls, University of Iowa
Study Sponsor  ICMJE University of Iowa
Collaborators  ICMJE
  • Direct MS Canada
  • DJO Incorporated
  • Pinnaclife Inc.
  • TZ Press, LLC
Investigators  ICMJE Not Provided
PRS Account University of Iowa
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP