Clinical trial NCT01381354: Nutrition, Neuromuscular Electrical Stimulation (NMES) and Secondary Progressive Multiple Sclerosis (SPMS)
Official title: Nutrition, Neuromuscular Electrical Stimulation (NMES) and Secondary Progressive Multiple Sclerosis (SPMS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis
Keywords: Secondary Progressive Multiple Sclerosis, primary progressive multiple sclerosis
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Direct MS Canada
name: DJO Incorporated
name: Pinnaclife Inc.
name: TZ Press, LLC
First posted: 2011-06-27
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Fatigue severity scale
timeFrame: Baseline, 3 M, 6M, 9M,12 M
Secondary outcomes:
measure: 25 foot walk
timeFrame: baseline, 3M, 6M, 9M, 12M, 18M, 24M 36M
measure: Short Form 36
timeFrame: baseline, 3M, 6M, 9M, 12M, 18M, 24M, 36 M
measure: Mood scales
timeFrame: Baseline, 3 M, 6M, 9M, 12M
measure: Cognitive Scales
timeFrame: baseline, 3 M, 6M, 9M, 12 M
measure: Medical Symptoms Questionnaire
timeFrame: baseline, 1 M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M, 18M, 24M, 36M
measure: Side effects log
timeFrame: Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M
measure: MS Function
timeFrame: Baseline, 3 M, 6M, 9M, 12M, 18M, 24M, 36M
measure: Multiple Sclerosis Spasticity Scale-88
timeFrame: Baseline, 3M, 6M,9M and 12M, 18M, 24M, 36M
measure: Daily log
timeFrame: Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M
measure: Vitamin log
timeFrame: Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M
measure: Medical examination
timeFrame: Baseline, 12 M
measure: Neurological examination
timeFrame: Baseline and 12 M
measure: Exposure history form
timeFrame: Baseline
measure: Health questions
timeFrame: Baseline
measure: Menses and pregnancy risk
timeFrame: Baseline, 3M, 6M, 9M, 12M
measure: Medication audit
timeFrame: Baseline, 12 M
measure: Functional diagnoses
timeFrame: Baseline
measure: Manual motor testing
timeFrame: Baseline, 3M, 6M, 9M, 12M
measure: Berg Balance
timeFrame: baseline, 3M, 6M, 9M, 12M
measure: Modified Ashworth
timeFrame: baseline, 3M, 6M, 9M, 12M
measure: Circumference
timeFrame: baseline, 3M, 6M, 9M, 12M
measure: Peak flow
timeFrame: baseline, 3M, 6M, 9M, 12M
measure: Number of falls in prior two months
timeFrame: Baseline, 3M, 6M, 9M,12M, 18M, 24M, 36M
measure: Dietary compliance
timeFrame: Baseline, 6 month and 12 month, 36 month
measure: Blood pressure
timeFrame: baseline, 3M, 6M, 9M, 12M
measure: Waist/ Hip ratio
timeFrame: baseline, 3M, 6M, 9M, 12M
measure: MS quality of life- 54
timeFrame: Baseline and months 3,6,9,12,18,24,and 36
measure: Blood Biomarkers
timeFrame: Baseline, 12 months
measure: Change in functional and structural brain Magnetic Resonance Imaging (MRI) measures
timeFrame: Between 1 and 12 month post intervention
measure: Fatigue severity scale
timeFrame: 18 M, 24 M, 36 M
measure: Get up and go test time
timeFrame: Baseline, 3M, 6M, 9M, 12M, 18M, 24M, 36M
measure: Change in weight and Body mass index (BMI)
timeFrame: Baseline, 3M, 6M, 9M, 12M, 18M, 24M, 36M
measure: Blood safety biomarkers
timeFrame: Baseline, 1M, 3M, 6M, 9M, 12M, 18M, 24M, 36M
measure: 9 hole peg board test
timeFrame: Baseline, 3M, 6M, 9M,12M, 18M, 24M, 36M
measure: Paced auditory serial addition task (PASAT)
timeFrame: Baseline, 3M, 6M,9M,12M, 18M,24M,36M
measure: Veteran specific activity questionnaire
timeFrame: Baseline, 3M, 6M, 9M, 12M, 18M,24M,36M
measure: Form 38- Daily life
timeFrame: 12M, 18M, 24M, 36M
measure: Urine toxicology
timeFrame: Baseline and 12 M
measure: Stool microbial profile
timeFrame: Baseline and 12M
measure: Harvard food frequency questionnaire and 24 hour food recalls
timeFrame: Baseline, 12M, 24M and 36M
measure: Bio impedance analysis
timeFrame: Baseline, 12M, 24M and 36M
measure: Exercise and electrical stimulation daily log
timeFrame: Daily baseline through 12M, 14 day-logs before/after 18M, 24M and 36M
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Univeristy of Iowa/ VA Iowa City VA Medical Center
state: Iowa
Study officials:
References:
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.
citation: 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.