Nutrition, Neuromuscular Electrical Stimulation (NMES) and Secondary Progressive Multiple Sclerosis (SPMS)
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 6/28/2018 |
| Start Date: | October 2010 |
| End Date: | May 2016 |
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.
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.
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.
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)
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