The Effects of the Magnetic Molecular Energizer (MME) on Diabetic Peripheral Neuropathy - Full Text View

Sponsored by:	Advanced Magnetic Research Institute International
Information provided by:	Advanced Magnetic Research Institute International
ClinicalTrials.gov Identifier:	NCT00134524

Purpose

This study is intended to demonstrate that exposure to a high intensity, DC electromagnetic field, as supplied by the investigational device known as the Molecular Magnetic Energizer (MME), will create a clinically meaningful improvement in pain and nerve dysfunction in the feet of patients with diabetic peripheral neuropathy (DPN).

Condition	Intervention	Phase
Diabetic Neuropathies Pain Neuralgia	Procedure: MME procedure	Phase III

MedlinePlus related topics: Diabetic Nerve Problems Peripheral Nerve Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Sham-Controlled Clinical Study to Evaluate The Effect of the Magnetic Molecular Energizer (MME) on Diabetic Peripheral Neuropathy

Further study details as provided by Advanced Magnetic Research Institute International:

Primary Outcome Measures:

Improvement in neurologic function following procedure
Improvement in DPN related pain following procedure
Subject tolerance to the MME procedure

Secondary Outcome Measures:

Neurologic function at 6 month follow-up
Pain level at 6 month follow-up
Quality of Life assessments at baseline, post-procedure and 6 month follow-up

Estimated Enrollment:	100
Study Start Date:	July 2005
Estimated Study Completion Date:	January 2008

Detailed Description:

Diabetic peripheral neuropathy (DPN) affects up to 1/2 of diabetics, both type I and II. It contributes to limb amputation, and can cause painful symptoms which are difficult to treat. Application of a high intensity, DC electromagnetic field, as supplied by the investigational device the Magnetic Molecular Energizer (MME) has shown in a pilot study with participants having DPN in their feet, to have created significant improvement in painful symptoms and improved measures of neurologic function in 7 of 10 participants. This study will enroll participants and evaluate them at baseline with regard to pain levels, nerve function and quality of life. They will then be randomized to receive 120 hr exposure to either active MME procedure, or sham procedure. Following the 120 hrs the participants will then receive the same evaluation for pain level, nerve function and quality of life. These evaluations will be repeated a final time 6 months following. The participants will be blinded to whether they receive the active or sham procedure.

The MME procedure consists of laying on a bed with the feet lying in the space between two large electromagnetic coils which, when activated, produce a DC magnetic field measuring 5000 gauss. The participants will lay on the bed with feet in the magnetic field for 8 to 12 hours a day for 10 to 16 days in succession. Breaks are allowed, and no restraints are required. The procedure may be done at night so that participants may sleep.

Pain assessment will be done by self assessment using rating with the Visual Analogue Scale.

Neurologic function will be assessed with Cutaneous Perception Threshold testing using the Neurometer, a commercially available, FDA approved device.

Quality of life assessment will be by the Neuropathy Specific Quality of Life Questionnaire.

Eligibility

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with diabetic peripheral neuropathy in feet with associated pain/discomfort.
Stable and controlled diabetes with hemoglobin A1c level less than 9.0% at entry into the study. Diabetes type I or type II accepted.
Subjects must be able to read English.

Exclusion Criteria:

Pacemakers, defibrillators, aneurysm clips, cochlear implants, any metallic particles in eyes or ferromagnetic metal shrapnel, projectile or implant in body.
Pregnant women
Concurrent neuropathy not due to diabetes.
Unstable cardiac disease or uncontrolled blood pressure.
Renal failure
Active hepatitis
History of nerve injury to lower extremities.
History of spinal surgery or total knee arthroplasty
Current malignancy
Alcoholism
History of stroke
Seizure disorder
Current use of long acting narcotic medication
Skin ulceration or breakdown of the lower extremities
Peripheral vascular disease sufficient to cause extremity pain at rest.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134524

Locations

United States, Arizona
AMRI Arizona
Tucson, Arizona, United States, 85711
United States, Michigan
AMRI MI
Sterling Heights, Michigan, United States, 48313
United States, North Carolina
AMRI NC
Mocksville, North Carolina, United States, 27208
United States, Ohio
AMRI NW OH
Toledo, Ohio, United States, 48313
United States, Washington
AMRI WA
Renton, Washington, United States, 98055

Sponsors and Collaborators

Advanced Magnetic Research Institute International

Investigators

Study Director:

Wayne R Bonlie, MD

AMRI International

More Information

Study sponsor, AMRI International website homepage This link exits the ClinicalTrials.gov site

Study ID Numbers:	AMRI-DPN-01
Study First Received:	August 22, 2005
Last Updated:	July 8, 2007
ClinicalTrials.gov Identifier:	NCT00134524
Health Authority:	United States: Institutional Review Board

Keywords provided by Advanced Magnetic Research Institute International:

Magnetics
Electromagnetics
Diabetic neuropathy
Pain

Study placed in the following topic categories:

Signs and Symptoms
Neuromuscular Diseases
Neuralgia
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Mellitus

Neurologic Manifestations
Endocrine System Diseases
Pain
Endocrinopathy
Diabetes Complications

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009