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.
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
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Progressive strengthening exercises designed to improve core muscles and muscles of ambulation.
Neuromuscular electrical stimulation to train core muscles and ambulation muscles. Device is Empi 300 manufactured by DJO Inc.
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.
Univeristy of Iowa/ VA Iowa City VA Medical Center
Iowa City, Iowa, United States
Fatigue severity scale
Self reported fatigue severity scale, (agreement with 9 questions describing impact of fatigue on daily activities)
Time frame: Baseline, 3 M, 6M, 9M,12 M
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.
Time frame: baseline, 3M, 6M, 9M, 12M, 18M, 24M 36M
Short Form 36
Self reported function in multiple domains.
Time frame: baseline, 3M, 6M, 9M, 12M, 18M, 24M, 36 M
Mood scales
Beck depression index, Beck anxiety index
Time frame: Baseline, 3 M, 6M, 9M, 12M
Cognitive Scales
Cognitive stability index or cognitive stability test, subscales of Dkef, Wtar, Wais III.
Time frame: baseline, 3 M, 6M, 9M, 12 M
Medical Symptoms Questionnaire
Detailed review of systems which is scored 0 to 4 for each item.
Time frame: baseline, 1 M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M, 18M, 24M, 36M
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.
Time frame: Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
4 grams daily by mouth.
Two capsules daily.
Two capsules twice daily.
One scoop daily.
Two capsules daily
500 mg daily
Methyl B12 1000 mcg daily
one gram daily
one teaspoon daily
100 mg daily
200 mg daily
1 gram daily
300 mg twice daily
500 mg twice daily
1000 mcg one pill four times a week
100 mg daily
meditation 15 minutes daily
self massage of hands, feet, ears 15 minutes daily
completing puzzles or learning 15 minutes daily
If excessive weight loss occurs, the subject will add 1-2 tablespoons of coconut oil daily to smoothies or foods eaten.
MS Function
Self reported disability scales (from North American Research committee on Multiple Sclerosis)
Time frame: Baseline, 3 M, 6M, 9M, 12M, 18M, 24M, 36M
Multiple Sclerosis Spasticity Scale-88
88 Questions about the impact of spasticity on various activities of daily living
Time frame: Baseline, 3M, 6M,9M and 12M, 18M, 24M, 36M
Daily log
Daily reports of foods consumed, exercises and activities completed.
Time frame: Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M
Vitamin log
Log of vitamins supplement bottles date opened, date emptied, pill size, number of pills in bottle.
Time frame: Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M
Medical examination
Medical examination
Time frame: Baseline, 12 M
Neurological examination
Neurological examination
Time frame: Baseline and 12 M
Exposure history form
History of exposures to chemicals.
Time frame: Baseline
Health questions
health questions about chronic disease states
Time frame: Baseline
Menses and pregnancy risk
Questions about menses and potential for pregnancy
Time frame: Baseline, 3M, 6M, 9M, 12M
Medication audit
Medications
Time frame: Baseline, 12 M
Functional diagnoses
Questions about past medical history
Time frame: Baseline
Manual motor testing
Manual motor testing of arms, legs and core muscle groups.
Time frame: Baseline, 3M, 6M, 9M, 12M
Berg Balance
Tests of balance which are progressively more challenging.
Time frame: baseline, 3M, 6M, 9M, 12M
Modified Ashworth
Test of spasticity by physical examination.
Time frame: baseline, 3M, 6M, 9M, 12M
Circumference
Circ. of waist, hips, R and+ L calf and R. and L. thigh.
Time frame: baseline, 3M, 6M, 9M, 12M
Peak flow
Peak expiratory flow rate.
Time frame: baseline, 3M, 6M, 9M, 12M
Number of falls in prior two months
Self reported number of falls and associated factors contributing to fall and severity of fall related injuries.
Time frame: Baseline, 3M, 6M, 9M,12M, 18M, 24M, 36M
Dietary compliance
Assessments, self report, Harvard Food Frequency (baseline, 12 month), 24 hour dietary recalls (6M)
Time frame: Baseline, 6 month and 12 month, 36 month
Blood pressure
blood pressure
Time frame: baseline, 3M, 6M, 9M, 12M
Waist/ Hip ratio
circumference of waist over the circumference of hip
Time frame: baseline, 3M, 6M, 9M, 12M
MS quality of life- 54
Quality of life questionnaires asking about various aspects of daily life.
Time frame: Baseline and months 3,6,9,12,18,24,and 36
Blood Biomarkers
Blood biomarkers of inflammation, and nutritional status.
Time frame: Baseline, 12 months
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
Time frame: Between 1 and 12 month post intervention
Fatigue severity scale
Self reported fatigue severity scale, (agreement with 9 questions describing impact of fatigue on daily activities)
Time frame: 18 M, 24 M, 36 M
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.
Time frame: Baseline, 3M, 6M, 9M, 12M, 18M, 24M, 36M
Change in weight and Body mass index (BMI)
weight measured in Kg Body mass index (BMI)
Time frame: Baseline, 3M, 6M, 9M, 12M, 18M, 24M, 36M
Blood safety biomarkers
Kidney and liver function tests and complete blood count
Time frame: Baseline, 1M, 3M, 6M, 9M, 12M, 18M, 24M, 36M
9 hole peg board test
Time to put 9 pegs in holes and take them out.
Time frame: Baseline, 3M, 6M, 9M,12M, 18M, 24M, 36M
Paced auditory serial addition task (PASAT)
Addition of two consecutive numbers during a series of numbers heard by subject.
Time frame: Baseline, 3M, 6M,9M,12M, 18M,24M,36M
Veteran specific activity questionnaire
Questions about the maximum physical activity level.
Time frame: Baseline, 3M, 6M, 9M, 12M, 18M,24M,36M
Form 38- Daily life
Questions about stressful life events.
Time frame: 12M, 18M, 24M, 36M
Urine toxicology
24 hours urine collection and measurement of heavy metals.
Time frame: Baseline and 12 M
Stool microbial profile
DNA probe for bacteria, parasites and yeast DNA.
Time frame: Baseline and 12M
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.
Time frame: Baseline, 12M, 24M and 36M
Bio impedance analysis
Test to analyze body composition.
Time frame: Baseline, 12M, 24M and 36M
Exercise and electrical stimulation daily log
Record of exercise, use of electrical stimulation on muscles and physical activity.
Time frame: Daily baseline through 12M, 14 day-logs before/after 18M, 24M and 36M