Frequency Modulated Neural Stimulation (FREMS) in Symptomatic Diabetic Neuropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2010-04-30

Brief Summary

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Aim of this study is to evaluate safety and efficacy of transcutaneous frequency modulated electromagnetic neural stimulation (FREMS) to treat symptomatic peripheral neuropathy in patients with diabetes mellitus.

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Detailed Description

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Diabetic neuropathy is a common and potentially disabling complication of patients with type 1 or type 2 diabetes due to the damage of peripheral nerves caused by chronic hyperglycemia. The most common clinical signs and symptoms of diabetic neuropathy include numbness, diminished sensation and painful symptoms, such as burning, pins and needles, intolerable pain and hyperaesthesia of the lower extremities.

Different classes of drugs, such as analgesics, antidepressants and anti-epileptics are variably efficacious in pain relief, but are unfortunately unable to revert the natural history of the disease.

A wide range of electrotherapies have been proposed for the non-pharmacological treatment of diabetic neuropathy. The rationale of using electric or magnetic stimulation is the potential enhancement of microcirculation and endoneural blood flow, possibly counteracting the nerve ischemic damage, together with other yet poorly understood mechanisms, such as masking pain by interfering with pain gate control.

A number of studies have reported the efficacy of different electrotherapies, such as transcutaneous electrical nerve stimulation (TENS), pulsed-dose electrical stimulation, peripheral nerve, nerve root, spinal cord, deep brain and epidural motor cortex stimulations, pulsed (electro-)magnetic fields and static magnetic fields, high-frequency external muscle stimulation, high-tone external muscle stimulation and external muscle stimulation. However, of all these electrotherapies, only TENS is currently recommended as a treatment for painful diabetic neuropathy by the American Academy of Neurology.

Recently, a novel transcutaneous frequency-modulated electromagnetic neural stimulation (also named as Frequency Rhythmic Electrical Modulation System, FREMS), has been developed. FREMS consists of a sequence of modulated electrical stimuli that varies automatically in terms of pulse frequency, duration and voltage amplitude. FREMS was tested in a pilot randomized, cross-over study, and reduced diabetic neuropathy pain and ameliorated the sensory tactile and vibration perception threshold and motor nerve conduction velocity compared to a sham treatment.

The aim of this study was to test the efficacy and safety of FREMS in a multicentre, randomized, double-blind, placebo-controlled study enrolling a large population with symptomatic diabetic polyneuropathy, with repeated treatment sessions and a post-treatment follow-up of adequate length.

Conditions

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Diabetic Neuropathy, Painful

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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FREMS

Frequency Modulated Neural Stimulation (FREMS)

Group Type EXPERIMENTAL

Frequency Modulated Neural Stimulation (FREMS) (Aptiva)

Intervention Type DEVICE

FREMS consisted of sequences of biphasic (negative and positive), asymmetric and electrically balanced pulses, composed of: 1) an active phase of high negative voltage spike (variable, max -300 V) and extra short duration (variable, 10-100 μsec, mostly \~40 μsec); followed by: 2) a recharging phase of low voltage and long duration (0.9 - 999 msec); pulse frequency was variable, ranging 1 to 1,000 Hz, mainly in the low range 1-50 Hz. Three cycles of 10 consecutive (one a day for 5 days/week) applications to both lower limbs were delivered.

Control

Group Type SHAM_COMPARATOR

sham treatment (Aptiva)

Intervention Type DEVICE

The sham treatment consisted of no electrical pulses delivered by the same device used to deliver the FREMS treatment and with the same treatment procedure and schedule.

Interventions

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Frequency Modulated Neural Stimulation (FREMS) (Aptiva)

FREMS consisted of sequences of biphasic (negative and positive), asymmetric and electrically balanced pulses, composed of: 1) an active phase of high negative voltage spike (variable, max -300 V) and extra short duration (variable, 10-100 μsec, mostly \~40 μsec); followed by: 2) a recharging phase of low voltage and long duration (0.9 - 999 msec); pulse frequency was variable, ranging 1 to 1,000 Hz, mainly in the low range 1-50 Hz. Three cycles of 10 consecutive (one a day for 5 days/week) applications to both lower limbs were delivered.

Intervention Type DEVICE

sham treatment (Aptiva)

The sham treatment consisted of no electrical pulses delivered by the same device used to deliver the FREMS treatment and with the same treatment procedure and schedule.

Intervention Type DEVICE

Other Intervention Names

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Aptiva device (Lorenz Biotech, Medolla, Italy) Aptiva device (Lorenz Biotech, Medolla, Italy)

Eligibility Criteria

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Inclusion Criteria

* Type 1 or Type 2 diabetes
* Diabetes duration of \> 1 year
* Age: 18 to 75 years
* Symptomatic neuropathy
* Abnormal amplitude, latency or conduction velocity in at least one motor nerve (Tibial or Peroneal) or in the Sural Nerve
* A measurable Sural Nerve conduction velocity
* Stable glycemic control in the last 3 months, HbA1C \< 11%
* MDNS score \> 7
* Stable dose of analgesic medications, if any, in the month prior enrollment

Exclusion Criteria

* Previous treatment with TENS or other electrotherapy
* Motor or Sensitive nerve conduction velocity \< 30 non recordable/evocable
* Unstable glycemic control during last 3 months
* Pregnancy
* Implanted pacemaker or defibrillator or neurostimulator
* Cancer diagnosed in the last 5 years
* Psychological or psychiatric disorders that in the Investigator's opinion may interfere with patient's compliance to study procedures
* Active foot ulcer and/or major lower limb amputation
* Diabetic mononeuropathy
* Severe peripheral artery disease (Leriche Fontaine scale grade 3 and 4)
* Ankle-brachial index (ABI) \< 0.7
* Uremic neuropathy or end-stage renal disease
* Toxic neuropathies
* Severe hepatic disease
* Alcohol consumption ≥ 40 g/day or 30 units/week

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No