Multiple Sclerosis
Conditions
Keywords
Secondary Progressive Multiple Sclerosis, primary progressive multiple sclerosis
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.
Interventions
OTHERProgressive exercise
Progressive strengthening exercises designed to improve core muscles and muscles of ambulation.
DEVICENeuromuscular 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.
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_SUPPLEMENTOmega 3 fatty acids
4 grams daily by mouth.
DIETARY_SUPPLEMENTFull Spectrum vitamin
Two capsules daily.
DIETARY_SUPPLEMENTEssential - hydroxytyrosol
Two capsules twice daily.
DIETARY_SUPPLEMENTMaltodextrin fiber supplement
One scoop daily.
DIETARY_SUPPLEMENTMineral boost (magnesium)
Two capsules daily
DIETARY_SUPPLEMENTNiacinamide
500 mg daily
DIETARY_SUPPLEMENTMethyl B12
Methyl B12 1000 mcg daily
DIETARY_SUPPLEMENTTaurine
one gram daily
DIETARY_SUPPLEMENTcreatine
one teaspoon daily
DIETARY_SUPPLEMENTthiamine
100 mg daily
DIETARY_SUPPLEMENTriboflavin
200 mg daily
DIETARY_SUPPLEMENTN acetylcysteine
1 gram daily
DIETARY_SUPPLEMENTalpha lipoic acid
300 mg twice daily
DIETARY_SUPPLEMENTL acetyl carnitine
500 mg twice daily
DIETARY_SUPPLEMENTmethyl folate
1000 mcg one pill four times a week
DIETARY_SUPPLEMENTcoenzyme Q
100 mg daily
BEHAVIORALmeditation
meditation 15 minutes daily
BEHAVIORALself massage
self massage of hands, feet, ears 15 minutes daily
BEHAVIORALlearning
completing puzzles or learning 15 minutes daily
DIETARY_SUPPLEMENTCoconut oil
If excessive weight loss occurs, the subject will add 1-2 tablespoons of coconut oil daily to smoothies or foods eaten.
Sponsors
Direct MS Canada
DJO Incorporated
Pinnaclife Inc.
TZ Press, LLC
University of Iowa
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue severity scale | Baseline, 3 M, 6M, 9M,12 M | Self reported fatigue severity scale, (agreement with 9 questions describing impact of fatigue on daily activities) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Form 36 | baseline, 3M, 6M, 9M, 12M, 18M, 24M, 36 M | Self reported function in multiple domains. |
| Mood scales | Baseline, 3 M, 6M, 9M, 12M | Beck depression index, Beck anxiety index |
| Cognitive Scales | baseline, 3 M, 6M, 9M, 12 M | Cognitive stability index or cognitive stability test, subscales of Dkef, Wtar, Wais III. |
| Medical Symptoms Questionnaire | 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 | 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 | 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 | Baseline, 3M, 6M,9M and 12M, 18M, 24M, 36M | 88 Questions about the impact of spasticity on various activities of daily living |
| Daily log | 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 | 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 | Baseline, 12 M | Medical examination |
| Neurological examination | Baseline and 12 M | Neurological examination |
| Exposure history form | Baseline | History of exposures to chemicals. |
| Health questions | Baseline | health questions about chronic disease states |
| Menses and pregnancy risk | Baseline, 3M, 6M, 9M, 12M | Questions about menses and potential for pregnancy |
| Medication audit | Baseline, 12 M | Medications |
| Functional diagnoses | Baseline | Questions about past medical history |
| Manual motor testing | Baseline, 3M, 6M, 9M, 12M | Manual motor testing of arms, legs and core muscle groups. |
| Berg Balance | baseline, 3M, 6M, 9M, 12M | Tests of balance which are progressively more challenging. |
| Modified Ashworth | baseline, 3M, 6M, 9M, 12M | Test of spasticity by physical examination. |
| Circumference | baseline, 3M, 6M, 9M, 12M | Circ. of waist, hips, R and+ L calf and R. and L. thigh. |
| Peak flow | baseline, 3M, 6M, 9M, 12M | Peak expiratory flow rate. |
| Number of falls in prior two months | 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 | Baseline, 6 month and 12 month, 36 month | Assessments, self report, Harvard Food Frequency (baseline, 12 month), 24 hour dietary recalls (6M) |
| Blood pressure | baseline, 3M, 6M, 9M, 12M | blood pressure |
| Waist/ Hip ratio | baseline, 3M, 6M, 9M, 12M | circumference of waist over the circumference of hip |
| MS quality of life- 54 | Baseline and months 3,6,9,12,18,24,and 36 | Quality of life questionnaires asking about various aspects of daily life. |
| Blood Biomarkers | Baseline, 12 months | Blood biomarkers of inflammation, and nutritional status. |
| Change in functional and structural brain Magnetic Resonance Imaging (MRI) measures | 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 | 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 | 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) | Baseline, 3M, 6M, 9M, 12M, 18M, 24M, 36M | weight measured in Kg Body mass index (BMI) |
| Blood safety biomarkers | Baseline, 1M, 3M, 6M, 9M, 12M, 18M, 24M, 36M | Kidney and liver function tests and complete blood count |
| 9 hole peg board test | 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) | 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 | Baseline, 3M, 6M, 9M, 12M, 18M,24M,36M | Questions about the maximum physical activity level. |
| Form 38- Daily life | 12M, 18M, 24M, 36M | Questions about stressful life events. |
| 25 foot walk | 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. |
| Stool microbial profile | Baseline and 12M | DNA probe for bacteria, parasites and yeast DNA. |
| Harvard food frequency questionnaire and 24 hour food recalls | 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 | Baseline, 12M, 24M and 36M | Test to analyze body composition. |
| Exercise and electrical stimulation daily log | 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. |
| Urine toxicology | Baseline and 12 M | 24 hours urine collection and measurement of heavy metals. |
Countries
United States
Outcome results
None listed