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Multiple SclerosisPhase 1NCT01381354

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

A Phase 1 study testing Progressive exercise, Neuromuscular electrical stimulation delivered using the electrical therapy device EMPI 300 PV and Modified paleolithic diet in people with Multiple Sclerosis, run by University of Iowa at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Progressive exercise, Neuromuscular electrical stimulation delivered using the electrical therapy device EMPI 300 PV and Modified paleolithic diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
Oct 2010to May 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Univeristy of Iowa/ VA Iowa City VA Medical Center

    Iowa City, Iowa, 52246

Other trials in United States

About this study

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.

Read the 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.

Being tested
Progressive exercise, Neuromuscular electrical stimulation delivered using the electrical therapy device EMPI 300 PV, Modified paleolithic diet, Omega 3 fatty acids, Full Spectrum vitamin
Keywords
Secondary Progressive Multiple Sclerosis, primary progressive multiple sclerosis
Medical subject headings
Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Progressive exerciseOther

    Progressive strengthening exercises designed to improve core muscles and muscles of ambulation.

  • Neuromuscular electrical stimulation delivered using the electrical therapy device EMPI 300 PVDevice

    Also called NMES, electrical therapy

    Neuromuscular electrical stimulation to train core muscles and ambulation muscles. Device is Empi 300 manufactured by DJO Inc.

  • Modified paleolithic dietOther

    Also called 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 acidsDietary supplement

    Also called Pinnaclife Omega 3 fatty acids

    4 grams daily by mouth.

  • Full Spectrum vitaminDietary supplement

    Also called Pinnaclife

    Two capsules daily.

  • Essential - hydroxytyrosolDietary supplement

    Also called Pinnaclife Essential

    Two capsules twice daily.

  • Maltodextrin fiber supplementDietary supplement

    Also called Pinnaclife Cleanse

    One scoop daily.

  • Mineral boost (magnesium)Dietary supplement

    Also called Pinnaclife Mineral Boost.

    Two capsules daily

  • NiacinamideDietary supplement

    500 mg daily

  • Methyl B12Dietary supplement

    Methyl B12 1000 mcg daily

  • TaurineDietary supplement

    one gram daily

  • creatineDietary supplement

    one teaspoon daily

  • thiamineDietary supplement

    100 mg daily

  • riboflavinDietary supplement

    200 mg daily

  • N acetylcysteineDietary supplement

    1 gram daily

  • alpha lipoic acidDietary supplement

    300 mg twice daily

  • L acetyl carnitineDietary supplement

    500 mg twice daily

  • methyl folateDietary supplement

    1000 mcg one pill four times a week

  • coenzyme QDietary supplement

    100 mg daily

  • meditationBehavioural

    meditation 15 minutes daily

  • self massageBehavioural

    self massage of hands, feet, ears 15 minutes daily

  • learningBehavioural

    completing puzzles or learning 15 minutes daily

  • Coconut oilDietary supplement

    Also called 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.

Study groups in NCT01381354
Study groupRoleWhat they receive
Combined interventionExperimentalCombination 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fatigue severity scale

    Self reported fatigue severity scale, (agreement with 9 questions describing impact of fatigue on daily activities)

    Measured: Baseline, 3 M, 6M, 9M,12 M

Secondary outcomes (42)

  1. 25 foot walk

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

    Step and stride length, step and stride duration.

    Measured: baseline, 3M, 6M, 9M, 12M, 18M, 24M 36M

  2. Short Form 36

    Self reported function in multiple domains.

    Measured: baseline, 3M, 6M, 9M, 12M, 18M, 24M, 36 M

  3. Mood scales

    Beck depression index, Beck anxiety index

    Measured: Baseline, 3 M, 6M, 9M, 12M

  4. Cognitive Scales

    Cognitive stability index or cognitive stability test, subscales of Dkef, Wtar, Wais III.

    Measured: baseline, 3 M, 6M, 9M, 12 M

  5. Medical Symptoms Questionnaire

    Detailed review of systems which is scored 0 to 4 for each item.

    Measured: baseline, 1 M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M, 18M, 24M, 36M

  6. Side effects log

    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.

    Measured: Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M

  7. MS Function

    Self reported disability scales (from North American Research committee on Multiple Sclerosis)

    Measured: Baseline, 3 M, 6M, 9M, 12M, 18M, 24M, 36M

  8. Multiple Sclerosis Spasticity Scale-88

    88 Questions about the impact of spasticity on various activities of daily living

    Measured: Baseline, 3M, 6M,9M and 12M, 18M, 24M, 36M

  9. Daily log

    Daily reports of foods consumed, exercises and activities completed.

    Measured: Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M

  10. Vitamin log

    Log of vitamins supplement bottles date opened, date emptied, pill size, number of pills in bottle.

    Measured: Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M

  11. Medical examination

    Medical examination

    Measured: Baseline, 12 M

  12. Neurological examination

    Neurological examination

    Measured: Baseline and 12 M

  13. Exposure history form

    History of exposures to chemicals.

    Measured: Baseline

  14. Health questions

    health questions about chronic disease states

    Measured: Baseline

  15. Menses and pregnancy risk

    Questions about menses and potential for pregnancy

    Measured: Baseline, 3M, 6M, 9M, 12M

  16. Medication audit

    Medications

    Measured: Baseline, 12 M

  17. Functional diagnoses

    Questions about past medical history

    Measured: Baseline

  18. Manual motor testing

    Manual motor testing of arms, legs and core muscle groups.

    Measured: Baseline, 3M, 6M, 9M, 12M

  19. Berg Balance

    Tests of balance which are progressively more challenging.

    Measured: baseline, 3M, 6M, 9M, 12M

  20. Modified Ashworth

    Test of spasticity by physical examination.

    Measured: baseline, 3M, 6M, 9M, 12M

  21. Circumference

    Circ. of waist, hips, R and+ L calf and R. and L. thigh.

    Measured: baseline, 3M, 6M, 9M, 12M

  22. Peak flow

    Peak expiratory flow rate.

    Measured: baseline, 3M, 6M, 9M, 12M

  23. Number of falls in prior two months

    Self reported number of falls and associated factors contributing to fall and severity of fall related injuries.

    Measured: Baseline, 3M, 6M, 9M,12M, 18M, 24M, 36M

  24. Dietary compliance

    Assessments, self report, Harvard Food Frequency (baseline, 12 month), 24 hour dietary recalls (6M)

    Measured: Baseline, 6 month and 12 month, 36 month

  25. Blood pressure

    blood pressure

    Measured: baseline, 3M, 6M, 9M, 12M

  26. Waist/ Hip ratio

    circumference of waist over the circumference of hip

    Measured: baseline, 3M, 6M, 9M, 12M

  27. MS quality of life- 54

    Quality of life questionnaires asking about various aspects of daily life.

    Measured: Baseline and months 3,6,9,12,18,24,and 36

  28. Blood Biomarkers

    Blood biomarkers of inflammation, and nutritional status.

    Measured: Baseline, 12 months

  29. Change in functional and structural brain Magnetic Resonance Imaging (MRI) measures

    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

    Measured: Between 1 and 12 month post intervention

  30. Fatigue severity scale

    Self reported fatigue severity scale, (agreement with 9 questions describing impact of fatigue on daily activities)

    Measured: 18 M, 24 M, 36 M

  31. Get up and go test time

    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.

    Measured: Baseline, 3M, 6M, 9M, 12M, 18M, 24M, 36M

  32. Change in weight and Body mass index (BMI)

    weight measured in Kg Body mass index (BMI)

    Measured: Baseline, 3M, 6M, 9M, 12M, 18M, 24M, 36M

  33. Blood safety biomarkers

    Kidney and liver function tests and complete blood count

    Measured: Baseline, 1M, 3M, 6M, 9M, 12M, 18M, 24M, 36M

  34. 9 hole peg board test

    Time to put 9 pegs in holes and take them out.

    Measured: Baseline, 3M, 6M, 9M,12M, 18M, 24M, 36M

  35. Paced auditory serial addition task (PASAT)

    Addition of two consecutive numbers during a series of numbers heard by subject.

    Measured: Baseline, 3M, 6M,9M,12M, 18M,24M,36M

  36. Veteran specific activity questionnaire

    Questions about the maximum physical activity level.

    Measured: Baseline, 3M, 6M, 9M, 12M, 18M,24M,36M

  37. Form 38- Daily life

    Questions about stressful life events.

    Measured: 12M, 18M, 24M, 36M

  38. Urine toxicology

    24 hours urine collection and measurement of heavy metals.

    Measured: Baseline and 12 M

  39. Stool microbial profile

    DNA probe for bacteria, parasites and yeast DNA.

    Measured: Baseline and 12M

  40. Harvard food frequency questionnaire and 24 hour food recalls

    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.

    Measured: Baseline, 12M, 24M and 36M

  41. Bio impedance analysis

    Test to analyze body composition.

    Measured: Baseline, 12M, 24M and 36M

  42. Exercise and electrical stimulation daily log

    Record of exercise, use of electrical stimulation on muscles and physical activity.

    Measured: Daily baseline through 12M, 14 day-logs before/after 18M, 24M and 36M

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2011 (estimated)
  2. Study startOct 2010
  3. Primary completionFeb 2016
  4. Study completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01381354
Sponsor's protocol ID
200911781
Status last verified
Jun 2018
First submitted
26 May 2011
Last updated
26 Jun 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21138391

  • 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.

    PubMed 19918474

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Progressive exercise, Neuromuscular electrical stimulation delivered using the electrical therapy device EMPI 300 PV and Modified paleolithic diet in people with Multiple Sclerosis, run by University of Iowa at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fatigue severity scale (time frame: Baseline, 3 M, 6M, 9M,12 M). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01381354, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.

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