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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT01381354
Date of registration: 26/05/2011
Prospective Registration: No
Primary sponsor: University of Iowa
Public title: Nutrition, Neuromuscular Electrical Stimulation (NMES) and Secondary Progressive Multiple Sclerosis (SPMS)
Scientific title: Nutrition, Neuromuscular Electrical Stimulation (NMES) and Secondary Progressive Multiple Sclerosis (SPMS)
Date of first enrolment: October 2010
Target sample size: 38
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01381354
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1
Countries of recruitment
United States
Contacts
Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Multiple Sclerosis
Intervention(s)
Behavioral: learning
Behavioral: meditation
Behavioral: self massage
Device: Neuromuscular electrical stimulation delivered using the electrical therapy device EMPI 300 PV
Dietary Supplement: alpha lipoic acid
Dietary Supplement: Coconut oil
Dietary Supplement: coenzyme Q
Dietary Supplement: creatine
Dietary Supplement: Essential - hydroxytyrosol
Dietary Supplement: Full Spectrum vitamin
Dietary Supplement: L acetyl carnitine
Dietary Supplement: Maltodextrin fiber supplement
Dietary Supplement: Methyl B12
Dietary Supplement: methyl folate
Dietary Supplement: Mineral boost (magnesium)
Dietary Supplement: N acetylcysteine
Dietary Supplement: Niacinamide
Dietary Supplement: Omega 3 fatty acids
Dietary Supplement: riboflavin
Dietary Supplement: Taurine
Dietary Supplement: thiamine
Other: Modified paleolithic diet
Other: Progressive exercise
Primary Outcome(s)
Fatigue severity scale [Time Frame: Baseline, 3 M, 6M, 9M,12 M]
Secondary Outcome(s)
25 foot walk [Time Frame: baseline, 3M, 6M, 9M, 12M, 18M, 24M 36M]
9 hole peg board test [Time Frame: Baseline, 3M, 6M, 9M,12M, 18M, 24M, 36M]
Berg Balance [Time Frame: baseline, 3M, 6M, 9M, 12M]
Bio impedance analysis [Time Frame: Baseline, 12M, 24M and 36M]
Blood Biomarkers [Time Frame: Baseline, 12 months]
Blood pressure [Time Frame: baseline, 3M, 6M, 9M, 12M]
Blood safety biomarkers [Time Frame: Baseline, 1M, 3M, 6M, 9M, 12M, 18M, 24M, 36M]
Change in functional and structural brain Magnetic Resonance Imaging (MRI) measures [Time Frame: Between 1 and 12 month post intervention]
Change in weight and Body mass index (BMI) [Time Frame: Baseline, 3M, 6M, 9M, 12M, 18M, 24M, 36M]
Circumference [Time Frame: baseline, 3M, 6M, 9M, 12M]
Cognitive Scales [Time Frame: baseline, 3 M, 6M, 9M, 12 M]
Daily log [Time Frame: Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M]
Dietary compliance [Time Frame: Baseline, 6 month and 12 month, 36 month]
Exercise and electrical stimulation daily log [Time Frame: Daily baseline through 12M, 14 day-logs before/after 18M, 24M and 36M]
Exposure history form [Time Frame: Baseline]
Fatigue severity scale [Time Frame: 18 M, 24 M, 36 M]
Form 38- Daily life [Time Frame: 12M, 18M, 24M, 36M]
Functional diagnoses [Time Frame: Baseline]
Get up and go test time [Time Frame: Baseline, 3M, 6M, 9M, 12M, 18M, 24M, 36M]
Harvard food frequency questionnaire and 24 hour food recalls [Time Frame: Baseline, 12M, 24M and 36M]
Health questions [Time Frame: Baseline]
Manual motor testing [Time Frame: Baseline, 3M, 6M, 9M, 12M]
Medical examination [Time Frame: Baseline, 12 M]
Medical Symptoms Questionnaire [Time Frame: baseline, 1 M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M, 18M, 24M, 36M]
Medication audit [Time Frame: Baseline, 12 M]
Menses and pregnancy risk [Time Frame: Baseline, 3M, 6M, 9M, 12M]
Modified Ashworth [Time Frame: baseline, 3M, 6M, 9M, 12M]
Mood scales [Time Frame: Baseline, 3 M, 6M, 9M, 12M]
MS Function [Time Frame: Baseline, 3 M, 6M, 9M, 12M, 18M, 24M, 36M]
MS quality of life- 54 [Time Frame: Baseline and months 3,6,9,12,18,24,and 36]
Multiple Sclerosis Spasticity Scale-88 [Time Frame: Baseline, 3M, 6M,9M and 12M, 18M, 24M, 36M]
Neurological examination [Time Frame: Baseline and 12 M]
Number of falls in prior two months [Time Frame: Baseline, 3M, 6M, 9M,12M, 18M, 24M, 36M]
Paced auditory serial addition task (PASAT) [Time Frame: Baseline, 3M, 6M,9M,12M, 18M,24M,36M]
Peak flow [Time Frame: baseline, 3M, 6M, 9M, 12M]
Short Form 36 [Time Frame: baseline, 3M, 6M, 9M, 12M, 18M, 24M, 36 M]
Side effects log [Time Frame: Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M]
Stool microbial profile [Time Frame: Baseline and 12M]
Urine toxicology [Time Frame: Baseline and 12 M]
Veteran specific activity questionnaire [Time Frame: Baseline, 3M, 6M, 9M, 12M, 18M,24M,36M]
Vitamin log [Time Frame: Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M]
Waist/ Hip ratio [Time Frame: baseline, 3M, 6M, 9M, 12M]
Secondary ID(s)
200911781
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Direct MS Canada
DJO Incorporated
Pinnaclife Inc.
TZ Press, LLC
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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