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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01381354
• Other study ID #: 200911781
• Status: Completed
• Phase: Phase 1
• Start date: October 2010
• Est. completion date: May 2016

Study information

• Verified date: June 2018
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 disability in the setting of secondary and primary progressive multiple sclerosis with gait disability.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Sclerosis

Intervention

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:
• 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.

Dietary Supplement:
• 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

Behavioral:
• meditation
meditation 15 minutes daily
• self massage
self massage of hands, feet, ears 15 minutes daily
• 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.

Locations

Country	Name	City	State
United States	Univeristy of Iowa/ VA Iowa City VA Medical Center	Iowa City	Iowa

Sponsors (5)

Lead Sponsor	Collaborator
University of Iowa	Direct MS Canada, DJO Incorporated, Pinnaclife Inc., TZ Press, LLC

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue severity scale	Self reported fatigue severity scale, (agreement with 9 questions describing impact of fatigue on daily activities)	Baseline, 3 M, 6M, 9M,12 M
Secondary	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.	baseline, 3M, 6M, 9M, 12M, 18M, 24M 36M
Secondary	Short Form 36	Self reported function in multiple domains.	baseline, 3M, 6M, 9M, 12M, 18M, 24M, 36 M
Secondary	Mood scales	Beck depression index, Beck anxiety index	Baseline, 3 M, 6M, 9M, 12M
Secondary	Cognitive Scales	Cognitive stability index or cognitive stability test, subscales of Dkef, Wtar, Wais III.	baseline, 3 M, 6M, 9M, 12 M
Secondary	Medical Symptoms Questionnaire	Detailed review of systems which is scored 0 to 4 for each item.	baseline, 1 M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M, 18M, 24M, 36M
Secondary	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.	Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M
Secondary	MS Function	Self reported disability scales (from North American Research committee on Multiple Sclerosis)	Baseline, 3 M, 6M, 9M, 12M, 18M, 24M, 36M
Secondary	Multiple Sclerosis Spasticity Scale-88	88 Questions about the impact of spasticity on various activities of daily living	Baseline, 3M, 6M,9M and 12M, 18M, 24M, 36M
Secondary	Daily log	Daily reports of foods consumed, exercises and activities completed.	Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M
Secondary	Vitamin log	Log of vitamins supplement bottles date opened, date emptied, pill size, number of pills in bottle.	Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M
Secondary	Medical examination	Medical examination	Baseline, 12 M
Secondary	Neurological examination	Neurological examination	Baseline and 12 M
Secondary	Exposure history form	History of exposures to chemicals.	Baseline
Secondary	Health questions	health questions about chronic disease states	Baseline
Secondary	Menses and pregnancy risk	Questions about menses and potential for pregnancy	Baseline, 3M, 6M, 9M, 12M
Secondary	Medication audit	Medications	Baseline, 12 M
Secondary	Functional diagnoses	Questions about past medical history	Baseline
Secondary	Manual motor testing	Manual motor testing of arms, legs and core muscle groups.	Baseline, 3M, 6M, 9M, 12M
Secondary	Berg Balance	Tests of balance which are progressively more challenging.	baseline, 3M, 6M, 9M, 12M
Secondary	Modified Ashworth	Test of spasticity by physical examination.	baseline, 3M, 6M, 9M, 12M
Secondary	Circumference	Circ. of waist, hips, R and+ L calf and R. and L. thigh.	baseline, 3M, 6M, 9M, 12M
Secondary	Peak flow	Peak expiratory flow rate.	baseline, 3M, 6M, 9M, 12M
Secondary	Number of falls in prior two months	Self reported number of falls and associated factors contributing to fall and severity of fall related injuries.	Baseline, 3M, 6M, 9M,12M, 18M, 24M, 36M
Secondary	Dietary compliance	Assessments, self report, Harvard Food Frequency (baseline, 12 month), 24 hour dietary recalls (6M)	Baseline, 6 month and 12 month, 36 month
Secondary	Blood pressure	blood pressure	baseline, 3M, 6M, 9M, 12M
Secondary	Waist/ Hip ratio	circumference of waist over the circumference of hip	baseline, 3M, 6M, 9M, 12M
Secondary	MS quality of life- 54	Quality of life questionnaires asking about various aspects of daily life.	Baseline and months 3,6,9,12,18,24,and 36
Secondary	Blood Biomarkers	Blood biomarkers of inflammation, and nutritional status.	Baseline, 12 months
Secondary	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	Between 1 and 12 month post intervention
Secondary	Fatigue severity scale	Self reported fatigue severity scale, (agreement with 9 questions describing impact of fatigue on daily activities)	18 M, 24 M, 36 M
Secondary	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.	Baseline, 3M, 6M, 9M, 12M, 18M, 24M, 36M
Secondary	Change in weight and Body mass index (BMI)	weight measured in Kg Body mass index (BMI)	Baseline, 3M, 6M, 9M, 12M, 18M, 24M, 36M
Secondary	Blood safety biomarkers	Kidney and liver function tests and complete blood count	Baseline, 1M, 3M, 6M, 9M, 12M, 18M, 24M, 36M
Secondary	9 hole peg board test	Time to put 9 pegs in holes and take them out.	Baseline, 3M, 6M, 9M,12M, 18M, 24M, 36M
Secondary	Paced auditory serial addition task (PASAT)	Addition of two consecutive numbers during a series of numbers heard by subject.	Baseline, 3M, 6M,9M,12M, 18M,24M,36M
Secondary	Veteran specific activity questionnaire	Questions about the maximum physical activity level.	Baseline, 3M, 6M, 9M, 12M, 18M,24M,36M
Secondary	Form 38- Daily life	Questions about stressful life events.	12M, 18M, 24M, 36M
Secondary	Urine toxicology	24 hours urine collection and measurement of heavy metals.	Baseline and 12 M
Secondary	Stool microbial profile	DNA probe for bacteria, parasites and yeast DNA.	Baseline and 12M
Secondary	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.	Baseline, 12M, 24M and 36M
Secondary	Bio impedance analysis	Test to analyze body composition.	Baseline, 12M, 24M and 36M
Secondary	Exercise and electrical stimulation daily log	Record of exercise, use of electrical stimulation on muscles and physical activity.	Daily baseline through 12M, 14 day-logs before/after 18M, 24M and 36M