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

NCT01381354 | Completed Phase 1 DMC

• 1 other identifier: 200911781
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Secondary Progressive Multiple Sclerosis, primary progressive multiple sclerosis

Outcome Measures

Primary Outcomes (1)

• Fatigue severity scale

  Self reported fatigue severity scale, (agreement with 9 questions describing impact of fatigue on daily activities)

  Baseline, 3 M, 6M, 9M,12 M

Secondary Outcomes (42)

• 25 foot walk

  baseline, 3M, 6M, 9M, 12M, 18M, 24M 36M

• Short Form 36

  baseline, 3M, 6M, 9M, 12M, 18M, 24M, 36 M

• Mood scales

  Baseline, 3 M, 6M, 9M, 12M

• Cognitive Scales

  baseline, 3 M, 6M, 9M, 12 M

• Medical Symptoms Questionnaire

  baseline, 1 M, 2M, 3M, 4M, 5M, 6M, 7M, 8M, 9M, 10 M, 11M, 12M, 18M, 24M, 36M

Study Arms (1)

Combined intervention

EXPERIMENTAL

Combination intervention consisting of the following: structured modified paleolithic diet, Progressive Exercise, Neuromuscular Electrical Stimulation designed to facilitate the adoption of multiple therapeutic lifestyle behaviors associated with superior health outcomes.

Other: Progressive exercise; Device: Neuromuscular electrical stimulation delivered using the electrical therapy device EMPI 300 PV; Other: Modified paleolithic diet; Dietary Supplement: Omega 3 fatty acids; Dietary Supplement: Full Spectrum vitamin; Dietary Supplement: Essential - hydroxytyrosol; Dietary Supplement: Maltodextrin fiber supplement; Dietary Supplement: Mineral boost (magnesium); Dietary Supplement: Niacinamide; Dietary Supplement: Methyl B12; Dietary Supplement: Taurine; Dietary Supplement: creatine; Dietary Supplement: thiamine; Dietary Supplement: riboflavin; Dietary Supplement: N acetylcysteine; Dietary Supplement: alpha lipoic acid; Dietary Supplement: L acetyl carnitine; Dietary Supplement: methyl folate; Dietary Supplement: coenzyme Q; Behavioral: meditation; Behavioral: self massage; Behavioral: learning; Dietary Supplement: Coconut oil

Interventions

Progressive exercise OTHER

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

Combined intervention

Neuromuscular electrical stimulation delivered using the electrical therapy device EMPI 300 PV DEVICE

Neuromuscular electrical stimulation to train core muscles and ambulation muscles. Device is Empi 300 manufactured by DJO Inc.

Also known as: NMES, electrical therapy

Combined intervention

Modified paleolithic diet OTHER

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.

Also known as: Wahls Diet, Paleolithic Diet, Gluten-free, Dairy-free.

Combined intervention

Omega 3 fatty acids DIETARY_SUPPLEMENT

4 grams daily by mouth.

Also known as: Pinnaclife Omega 3 fatty acids

Combined intervention

Full Spectrum vitamin DIETARY_SUPPLEMENT

Two capsules daily.

Also known as: Pinnaclife

Combined intervention

Essential - hydroxytyrosol DIETARY_SUPPLEMENT

Two capsules twice daily.

Also known as: Pinnaclife Essential

Combined intervention

Maltodextrin fiber supplement DIETARY_SUPPLEMENT

One scoop daily.

Also known as: Pinnaclife Cleanse

Combined intervention

Mineral boost (magnesium) DIETARY_SUPPLEMENT

Two capsules daily

Also known as: Pinnaclife Mineral Boost.

Combined intervention

Niacinamide DIETARY_SUPPLEMENT

500 mg daily

Combined intervention

Methyl B12 DIETARY_SUPPLEMENT

Methyl B12 1000 mcg daily

Combined intervention

Taurine DIETARY_SUPPLEMENT

one gram daily

Combined intervention

creatine DIETARY_SUPPLEMENT

one teaspoon daily

Combined intervention

thiamine DIETARY_SUPPLEMENT

100 mg daily

Combined intervention

riboflavin DIETARY_SUPPLEMENT

200 mg daily

Combined intervention

N acetylcysteine DIETARY_SUPPLEMENT

1 gram daily

Combined intervention

alpha lipoic acid DIETARY_SUPPLEMENT

300 mg twice daily

Combined intervention

L acetyl carnitine DIETARY_SUPPLEMENT

500 mg twice daily

Combined intervention

methyl folate DIETARY_SUPPLEMENT

1000 mcg one pill four times a week

Combined intervention

coenzyme Q DIETARY_SUPPLEMENT

100 mg daily

Combined intervention

meditation BEHAVIORAL

meditation 15 minutes daily

Combined intervention

self massage BEHAVIORAL

self massage of hands, feet, ears 15 minutes daily

Combined intervention

learning BEHAVIORAL

completing puzzles or learning 15 minutes daily

Combined intervention

Coconut oil DIETARY_SUPPLEMENT

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

Also known as: Extra virgin cold press coconut oil

Combined intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Iowa: lead
• Direct MS Canada: collaborator
• DJO Incorporated: collaborator
• Pinnaclife Inc.: collaborator
• TZ Press, LLC: collaborator

Study Sites (1)

Univeristy of Iowa/ VA Iowa City VA Medical Center

Iowa City, Iowa, 52246, United States

Location

Related Publications (2)

• 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.

  PMID: 21138391 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.

  PMID: 19918474 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive

Interventions

Diet, Paleolithic; Diet, Gluten-Free; Fatty Acids, Omega-3; Magnesium; Niacinamide; Taurine; Creatine; Thiamine; Riboflavin; Acetylcysteine; Thioctic Acid; Acetylcarnitine; 5-methyltetrahydrofolate; Ubiquinone; Meditation; Educational Status; Coconut Oil

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Guanidines; Amidines; Amino Acids; Amino Acids, Peptides, and Proteins; Thiazoles; Azoles; Pyrimidines; Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors; Cysteine; Amino Acids, Sulfur; Carboxylic Acids; Thiophenes; Carnitine; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Benzoquinones; Quinones; Mind-Body Therapies; Complementary Therapies; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Socioeconomic Factors; Population Characteristics; Plant Oils

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 26, 2011
• First Posted: June 27, 2011
• Study Start: October 1, 2010
• Primary Completion: February 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 26, 2018

Record last verified: 2018-06

Locations

US (1)