Clinical trial NCT00134524: The Effects of the Magnetic Molecular Energizer (MME) on Diabetic Peripheral Neuropathy
Official title: A Randomized, Sham-Controlled Clinical Study to Evaluate The Effect of the Magnetic Molecular Energizer (MME) on Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetic Neuropathies
Pain
Neuralgia
Keywords: Magnetics
Electromagnetics
Diabetic neuropathy
Pain
Lead sponsor: Advanced Magnetic Research Institute International
Sponsor class: INDUSTRY
First posted: 2005-08-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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.

Primary outcomes:
measure: Improvement in neurologic function following procedure
measure: Improvement in DPN related pain following procedure
measure: Subject tolerance to the MME procedure
Secondary outcomes:
measure: Neurologic function at 6 month follow-up
measure: Pain level at 6 month follow-up
measure: Quality of Life assessments at baseline, post-procedure and 6 month follow-up
Other outcomes:
Locations:
city: Tucson
country: United States
facility: AMRI Arizona
state: Arizona
city: Sterling Heights
country: United States
facility: AMRI MI
state: Michigan
city: Mocksville
country: United States
facility: AMRI NC
state: North Carolina
city: Toledo
country: United States
facility: Amri NW Oh
state: Ohio
city: Renton
country: United States
facility: AMRI WA
state: Washington
Study officials:
affiliation: AMRI International
name: Wayne R Bonlie, MD
role: STUDY_DIRECTOR
References: