The Effects of the Magnetic Molecular Energizer (MME) on Diabetic Peripheral Neuropathy

Sponsor

Advanced Magnetic Research Institute International (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00134524

Collaborator

(none)

100

Enrollment

Locations

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Diabetic Neuropathies Pain Neuralgia	Procedure: MME procedure	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Randomized, Sham-Controlled Clinical Study to Evaluate The Effect of the Magnetic Molecular Energizer (MME) on Diabetic Peripheral Neuropathy

Study Start Date :

Jul 1, 2005

Anticipated Study Completion Date :

Jan 1, 2008

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	AMRI Arizona	Tucson	Arizona	United States	85711
2	AMRI MI	Sterling Heights	Michigan	United States	48313
3	AMRI NC	Mocksville	North Carolina	United States	27208
4	Amri NW Oh	Toledo	Ohio	United States	48313
5	AMRI WA	Renton	Washington	United States	98055