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Trial record 16 of 133 for:    primary-progressive multiple sclerosis

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Direct MS Canada
DJO Incorporated
Pinnaclife Inc.
TZ Press, LLC
Information provided by (Responsible Party):
University of Iowa
ClinicalTrials.gov Identifier:
NCT01381354
First received: May 26, 2011
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nutrition, Neuromuscular Electrical Stimulation (NMES) and Secondary Progressive Multiple Sclerosis (SPMS)

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Fatigue severity scale [ Time Frame: Baseline, 3 M, 6M, 9M,12 M ] [ Designated as safety issue: No ]
    Self reported fatigue severity scale, (agreement with 9 questions describing impact of fatigue on daily activities)


Secondary Outcome Measures:
  • 25 foot walk [ Time Frame: baseline, 3M, 6M, 9M, 12M, 18M, 24M 36M ] [ Designated as safety issue: No ]

    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 ] [ 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, 12 M ] [ 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, 18M, 24M, 36M ] [ 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, 18M, 24M, 36M ] [ Designated as safety issue: No ]
    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 ] [ 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,12M, 18M, 24M, 36M ] [ 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, 36 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

  • MS quality of life- 54 [ Time Frame: Baseline and months 3,6,9,12,18,24,and 36 ] [ Designated as safety issue: No ]
    Quality of life questionnaires asking about various aspects of daily life.

  • Blood Biomarkers [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]
    weight measured in Kg Body mass index (BMI)

  • Blood safety biomarkers [ Time Frame: Baseline, 1M, 3M, 6M, 9M, 12M, 18M, 24M, 36M ] [ Designated as safety issue: Yes ]
    Kidney and liver function tests and complete blood count

  • 9 hole peg board test [ Time Frame: Baseline, 3M, 6M, 9M,12M, 18M, 24M, 36M ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Questions about the maximum physical activity level.

  • Form 38- Daily life [ Time Frame: 12M, 18M, 24M, 36M ] [ Designated as safety issue: No ]
    Questions about stressful life events.

  • Urine toxicology [ Time Frame: Baseline and 12 M ] [ Designated as safety issue: No ]
    24 hours urine collection and measurement of heavy metals.

  • Stool microbial profile [ Time Frame: Baseline and 12M ] [ Designated as safety issue: No ]
    DNA probe for bacteria, parasites and yeast DNA.

  • Harvard food frequency questionnaire and 24 hour food recalls [ Time Frame: Baseline, 12M, 24M and 36M ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Record of exercise, use of electrical stimulation on muscles and physical activity.


Estimated Enrollment: 40
Study Start Date: October 2010
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01381354

Locations
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
  More Information

Publications:
Responsible Party: University of Iowa
ClinicalTrials.gov Identifier: NCT01381354     History of Changes
Other Study ID Numbers: 200911781
Study First Received: May 26, 2011
Last Updated: August 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
Secondary Progressive Multiple Sclerosis, primary progressive multiple sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Acetylcarnitine
Acetylcysteine
N-monoacetylcystine
Thioctic Acid
Anti-Infective Agents
Antidotes
Antioxidants
Antiviral Agents
Central Nervous System Agents
Expectorants
Free Radical Scavengers
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014