Nutrition, Neuromuscular Electrical Stimulation (NMES) and Secondary Progressive Multiple Sclerosis (SPMS)
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Progressive exercise
- Neuromuscular electrical stimulation delivered using the electrical therapy device EMPI 300 PV
- Modified paleolithic diet
- Omega-3 fatty acids
- Full Spectrum vitamin
- Essential - hydroxytyrosol
- Maltodextrin fiber supplement
- Magnesium
- Niacinamide
- Methylcobalamin
- Taurine
- Creatine
- Thiamine ion
- Riboflavin
- N acetylcysteine
- Lipoic acid, alpha
- L acetyl carnitine
- methyl folate
- coenzyme Q
- meditation
- self massage
- learning
- Wax, emulsifying
What it measured
Main measures
Fatigue severity scale
Baseline, 3 M, 6M, 9M,12 M
Fatigue
Other measures (42)
25 foot walk
baseline, 3M, 6M, 9M, 12M, 18M, 24M 36M
Walking and mobilityShort Form 36
baseline, 3M, 6M, 9M, 12M, 18M, 24M, 36 M
Mood scales
Baseline, 3 M, 6M, 9M, 12M
Mood and sleepCognitive Scales
baseline, 3 M, 6M, 9M, 12 M
Thinking and memoryMedical Symptoms Questionnaire
baseline, 1 M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M, 18M, 24M, 36M
Side effects log
Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M
Physical functionSafetyMS Function
Baseline, 3 M, 6M, 9M, 12M, 18M, 24M, 36M
Multiple Sclerosis Spasticity Scale-88
Baseline, 3M, 6M,9M and 12M, 18M, 24M, 36M
SpasticityDaily log
Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M
Physical functionVitamin log
Baseline, 1M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M
Who could take part
Progressive MS · 18 to 65
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)
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
A multimodal intervention for patients with secondary progressive multiple sclerosis: feasibility and effect on fatigue.J Altern Complement Med · 2014
Background
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.Background
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.
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History
Started
Oct 2010
Main results due
Feb 2016
Finished
May 2016
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