Nutrition, Neuromuscular Electrical Stimulation (NMES) and Secondary Progressive Multiple Sclerosis (SPMS)

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.

Conditions

• Multiple Sclerosis

Interventions

OTHER

Progressive exercise

Progressive strengthening exercises designed to improve core muscles and muscles of ambulation.

DEVICE

Neuromuscular 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.

OTHER

Modified paleolithic diet

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_SUPPLEMENT

Omega 3 fatty acids

4 grams daily by mouth.

DIETARY_SUPPLEMENT

Full Spectrum vitamin

Two capsules daily.

DIETARY_SUPPLEMENT

Essential - hydroxytyrosol

Two capsules twice daily.

DIETARY_SUPPLEMENT

Maltodextrin fiber supplement

One scoop daily.

DIETARY_SUPPLEMENT

Mineral boost (magnesium)

Two capsules daily

DIETARY_SUPPLEMENT

Niacinamide

500 mg daily

DIETARY_SUPPLEMENT

Methyl B12

Methyl B12 1000 mcg daily

DIETARY_SUPPLEMENT

Taurine

one gram daily

DIETARY_SUPPLEMENT

creatine

one teaspoon daily

DIETARY_SUPPLEMENT

thiamine

100 mg daily

DIETARY_SUPPLEMENT

riboflavin

200 mg daily

DIETARY_SUPPLEMENT

N acetylcysteine

1 gram daily

DIETARY_SUPPLEMENT

alpha lipoic acid

300 mg twice daily

DIETARY_SUPPLEMENT

L acetyl carnitine

500 mg twice daily

DIETARY_SUPPLEMENT

methyl folate

1000 mcg one pill four times a week

DIETARY_SUPPLEMENT

coenzyme Q

100 mg daily

BEHAVIORAL

meditation

meditation 15 minutes daily

BEHAVIORAL

self massage

self massage of hands, feet, ears 15 minutes daily

BEHAVIORAL

learning

completing puzzles or learning 15 minutes daily

DIETARY_SUPPLEMENT

Coconut oil

If excessive weight loss occurs, the subject will add 1-2 tablespoons of coconut oil daily to smoothies or foods eaten.

Sponsors & Collaborators

• Direct MS Canada

  collaborator UNKNOWN

• DJO Incorporated

  collaborator INDUSTRY

• Pinnaclife Inc.

  collaborator INDUSTRY

• TZ Press, LLC

  collaborator UNKNOWN

• University of Iowa

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-10-31

Primary Completion

2016-02-29

Completion

2016-05-31

Countries

• United States

Study Locations