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Neuromuscular Electrical Stimulation For The Treatment of Diabetic Neuropathy (NMES-DN)

Primary Purpose

Diabetic Peripheral Neuropathy, Diabetic Neuropathies, Diabetic Polyneuropathy

Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Revitive Medic Coach (Actegy Ltd)
Sham Revitive Medic Coach (Actegy Ltd)
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Peripheral Neuropathy focused on measuring Neuromuscular electrical stimulation, Nerve conduction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA

  • Aged 18+
  • Diagnosis of Type 1 or Type 2 diabetes mellitus and receiving best medical therapy
  • Diagnosis of diabetic peripheral neuropathy based on: a validated screening questionnaire Michigan Neuropathy Screening Instrument questionnaire score of ≥ 7 and nerve conduction study of at least one lower limb meet the criteria for mild, moderate or severe DPN based on both sural and common peroneal testing
  • Has access to internet at home to use the Revitive App

EXCLUSION CRITERIA

  • Lacks capacity to provide informed consent
  • Pregnant
  • Has an implanted electronic, cardiac or defibrillator device
  • Has other cause of peripheral neuropathy (e.g. excessive drinking, low levels of vitamin B12 or other vitamins, syphilis, HIV, underactive thyroid gland)
  • Has current foot ulceration
  • Has severe vascular disease requiring invasive intervention
  • Being treated for, or have the symptoms of, an existing Deep Vein Thrombosis (DVT)
  • Already using a neuromuscular electrical stimulation device

Sites / Locations

  • Imperial College London

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Control group

Intervention group

Arm Description

Best Medical Therapy + Sham Revitive Medic Coach (Sham Neuromuscular Electrical Stimulation Device) for 6 months

Best Medical Therapy + Revitive Medic Coach (Neuromuscular Electrical Stimulation Device) for 6 months

Outcomes

Primary Outcome Measures

Primary outcome measure: sural nerve conductivity measured using a nerve conduction study at 6 months. This includes conduction velocity (m/s), calculated using distance and latency (ms), and sensory nerve action potential (SNAP) amplitude (μV).
Multi-component, single outcome. Nerve conduction parameters include sural nerve conduction velocity (m/s) and SNAP amplitude (µV).

Secondary Outcome Measures

Feasibility outcome measure: recruitment rate measured using screening and randomisation logs.
Feasibility outcome measure: participant retention rate measured using randomisation and withdrawal logs.
Feasibility outcome measure: adherence to treatment measured using Revitive App and a patient diary.
Safety outcome measure: Adverse Events (AEs) collected and reported via AE form.
Safety outcome measure: Adverse Device Effects (ADEs) collected and reported via AE form.
Safety outcome measure: Serious Adverse Events (SAEs) collected and reported via SAE form.
Safety outcome measure: Serious Adverse Device Effects (SADEs) collected and reported via SAE form.
Secondary outcome measure: superficial peroneal nerve conductivity measured using a nerve conduction study.
Nerve conduction parameters include conduction velocity (m/s), calculated using distance and latency (ms), and SNAP amplitude (μV).
Secondary outcome measure: common peroneal nerve conductivity measured using a nerve conduction study.
Nerve conduction parameters include conduction velocity (m/s), calculated using distance and distal latency (ms), Compound Muscle Action Potential (CMAP) amplitude (mV) and minimum F wave latency (ms).
Secondary outcome measure: tibial nerve conductivity measured using a nerve conduction study.
Nerve conduction parameters include conduction velocity (m/s), calculated using distance and distal latency (ms), Compound Muscle Action Potential (CMAP) amplitude (mV) and minimum F wave latency (ms).
Secondary outcome measure: somatosensory nerve fibre function measured using Quantitative Sensory Testing (QST).
Somatosensory nerve fibre function will be assessed using the German Research Network on Neuropathic Pain (DFNS) QST protocol. The battery of tests includes measures of cold and warm detection thresholds, paradoxical heat sensations, cold and heat pain thresholds, mechanical detection threshold, mechanical pain threshold, mechanical pain sensitivity, dynamic mechanical allodynia, temporal pain summation, vibration detection threshold and pressure pain threshold.
Secondary outcome measure: mobility and balance measured using validated Berg Balance Scale (BBS).
Secondary outcome measure: quality of life measured using validated EQ-5D-5L questionnaire.
Secondary outcome measure: illness perceptions measured using validated Brief Illness Perception Questionnaire (Brief IPQ).
Secondary outcome measure: neuropathy signs and symptoms measured using validated screening questionnaire, Michigan Neuropathy Screening Instrument (MNSI).
Secondary outcome measure: neuropathy symptoms measured using validated Self-administered Neuropathy Total Symptom Score (NTSS-6-SA).
Secondary outcome measure: protected sensation measured using monofilament test.
Secondary outcome measure: neuropathic pain measured using Neuropathic Pain Symptom Inventory (NPSI).
Secondary outcome measure: daily pain measured using 11-point Numerical Rating Scale (NRS) collected via text message.
Secondary outcome measure: daily sleep interference measured using Daily Sleep Interference Scale (DSIS) (30) collected via text message.
Secondary outcome measure: peripheral arterial perfusion measured using Ankle Brachial Pressure Index (ABPI).
Secondary outcome measure: device sensation measured using device sensory threshold and suprathreshold.
Secondary outcome measure: device experience measured using device experience questionnaire.
Secondary outcome measure: device credibility and expectancy measured using modified credibility and expectancy questionnaire.

Full Information

First Posted
November 27, 2018
Last Updated
July 13, 2023
Sponsor
Imperial College London
Collaborators
Actegy Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03767478
Brief Title
Neuromuscular Electrical Stimulation For The Treatment of Diabetic Neuropathy
Acronym
NMES-DN
Official Title
Neuromuscular Electrical Stimulation For The Treatment Of Diabetic Neuropathy: A Multicentre, Double-blind, Pilot, Randomised, Sham-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
Actegy Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Diabetic neuropathy (DN) is the most common complication of diabetes, affecting almost 50% of people with diabetes over the course of their lives. Symptoms vary from numbness to burning, aching and hypersensitivity in the lower limbs, indicative of sensory nerve loss. Motor neurons can also be affected, leading to muscle weakness and mobility issues, thus preventing patients from engaging in daily routines. Further sequelae include foot ulceration and Charcot neuroarthropathy, which are risk factors for lower limb amputation and mortality. In the United Kingdom, the annual costs of DN alone exceed £300 million, with further complications expected to cost an additional £1 billion. Currently, management strategies for DN focus on prevention and pain management. Neuromuscular electrical stimulation (NMES) is a novel nonpharmacological intervention for people with DN. NMES is the application of electrical impulses which are of sufficiency intensity to improve artificial contraction of the muscle tissue and may help with DN by improving nerve conductivity through direct stimulation of the nerves.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy, Diabetic Neuropathies, Diabetic Polyneuropathy, Diabetic Complication
Keywords
Neuromuscular electrical stimulation, Nerve conduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Best Medical Therapy + Sham Revitive Medic Coach (Sham Neuromuscular Electrical Stimulation Device) for 6 months
Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
Best Medical Therapy + Revitive Medic Coach (Neuromuscular Electrical Stimulation Device) for 6 months
Intervention Type
Device
Intervention Name(s)
Revitive Medic Coach (Actegy Ltd)
Other Intervention Name(s)
Footplate Neuromuscular Electrical Stimulation Device
Intervention Description
Use the device for two 30-minute sessions per day, a minimum of five hours per week for 6 months at suprathreshold (2 x motor threshold).
Intervention Type
Device
Intervention Name(s)
Sham Revitive Medic Coach (Actegy Ltd)
Other Intervention Name(s)
Sham Footplate Neuromuscular Electrical Stimulation Device
Intervention Description
Use the device for two 30-minute sessions per day, a minimum of five hours per week for 6 months at suprathreshold (2 x motor threshold).
Primary Outcome Measure Information:
Title
Primary outcome measure: sural nerve conductivity measured using a nerve conduction study at 6 months. This includes conduction velocity (m/s), calculated using distance and latency (ms), and sensory nerve action potential (SNAP) amplitude (μV).
Description
Multi-component, single outcome. Nerve conduction parameters include sural nerve conduction velocity (m/s) and SNAP amplitude (µV).
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Feasibility outcome measure: recruitment rate measured using screening and randomisation logs.
Time Frame
Pre-screening / Identification, Recruitment and Consent, Baseline
Title
Feasibility outcome measure: participant retention rate measured using randomisation and withdrawal logs.
Time Frame
Recruitment and Consent, Baseline, Month 6
Title
Feasibility outcome measure: adherence to treatment measured using Revitive App and a patient diary.
Time Frame
Month 6
Title
Safety outcome measure: Adverse Events (AEs) collected and reported via AE form.
Time Frame
Baseline, Week 2, Month 6, Month 9 (and any communication in between)
Title
Safety outcome measure: Adverse Device Effects (ADEs) collected and reported via AE form.
Time Frame
Baseline, Week 2, Month 6, Month 9 (and any communication in between)
Title
Safety outcome measure: Serious Adverse Events (SAEs) collected and reported via SAE form.
Time Frame
Baseline, Week 2, Month 6, Month 9 (and any communication in between)
Title
Safety outcome measure: Serious Adverse Device Effects (SADEs) collected and reported via SAE form.
Time Frame
Baseline, Week 2, Month 6, Month 9 (and any communication in between)
Title
Secondary outcome measure: superficial peroneal nerve conductivity measured using a nerve conduction study.
Description
Nerve conduction parameters include conduction velocity (m/s), calculated using distance and latency (ms), and SNAP amplitude (μV).
Time Frame
Month 6, Month 9
Title
Secondary outcome measure: common peroneal nerve conductivity measured using a nerve conduction study.
Description
Nerve conduction parameters include conduction velocity (m/s), calculated using distance and distal latency (ms), Compound Muscle Action Potential (CMAP) amplitude (mV) and minimum F wave latency (ms).
Time Frame
Month 6, Month 9
Title
Secondary outcome measure: tibial nerve conductivity measured using a nerve conduction study.
Description
Nerve conduction parameters include conduction velocity (m/s), calculated using distance and distal latency (ms), Compound Muscle Action Potential (CMAP) amplitude (mV) and minimum F wave latency (ms).
Time Frame
Month 6, Month 9
Title
Secondary outcome measure: somatosensory nerve fibre function measured using Quantitative Sensory Testing (QST).
Description
Somatosensory nerve fibre function will be assessed using the German Research Network on Neuropathic Pain (DFNS) QST protocol. The battery of tests includes measures of cold and warm detection thresholds, paradoxical heat sensations, cold and heat pain thresholds, mechanical detection threshold, mechanical pain threshold, mechanical pain sensitivity, dynamic mechanical allodynia, temporal pain summation, vibration detection threshold and pressure pain threshold.
Time Frame
Month 6, Month 9
Title
Secondary outcome measure: mobility and balance measured using validated Berg Balance Scale (BBS).
Time Frame
Month 6, Month 9
Title
Secondary outcome measure: quality of life measured using validated EQ-5D-5L questionnaire.
Time Frame
Month 6, Month 9
Title
Secondary outcome measure: illness perceptions measured using validated Brief Illness Perception Questionnaire (Brief IPQ).
Time Frame
Month 6, Month 9
Title
Secondary outcome measure: neuropathy signs and symptoms measured using validated screening questionnaire, Michigan Neuropathy Screening Instrument (MNSI).
Time Frame
Month 6, Month 9
Title
Secondary outcome measure: neuropathy symptoms measured using validated Self-administered Neuropathy Total Symptom Score (NTSS-6-SA).
Time Frame
Month 6, Month 9
Title
Secondary outcome measure: protected sensation measured using monofilament test.
Time Frame
Month 6, Month 9
Title
Secondary outcome measure: neuropathic pain measured using Neuropathic Pain Symptom Inventory (NPSI).
Time Frame
Month 6, Month 9
Title
Secondary outcome measure: daily pain measured using 11-point Numerical Rating Scale (NRS) collected via text message.
Time Frame
Daily for treatment phase (6 months)
Title
Secondary outcome measure: daily sleep interference measured using Daily Sleep Interference Scale (DSIS) (30) collected via text message.
Time Frame
Daily for treatment phase (6 months)
Title
Secondary outcome measure: peripheral arterial perfusion measured using Ankle Brachial Pressure Index (ABPI).
Time Frame
Baseline
Title
Secondary outcome measure: device sensation measured using device sensory threshold and suprathreshold.
Time Frame
Month 6, Month 9
Title
Secondary outcome measure: device experience measured using device experience questionnaire.
Time Frame
Month 6
Title
Secondary outcome measure: device credibility and expectancy measured using modified credibility and expectancy questionnaire.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA Aged ≥18 (no upper limit) Diagnosis of type 1 or type 2 diabetes based on World Health Organisation (WHO) definition Diagnosis of diabetic neuropathy based on: symptoms of diabetic neuropathy validated screening questionnaire Michigan Neuropathy Screening Instrument score of ≥4 nerve conduction study of at least one lower limb must have a sural SNAP amplitude of <6 μV or absent Access to internet at home to use the Revitive App (study smartphones will be provided) Personal mobile phone to receive text messages EXCLUSION CRITERIA Lacks capacity to provide informed consent Pregnant Implanted electronic, cardiac or defibrillator device Other cause of peripheral neuropathy (e.g. excessive drinking, low levels of vitamin B12 or other vitamins, syphilis, HIV, underactive thyroid gland) Current foot ulceration Severe vascular disease requiring invasive intervention Being treated for, or have the symptoms of, an existing deep vein thrombosis (DVT) Used a neuromuscular electrical stimulation (NMES) device within 1 year of randomisation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tristan R A Lane, MBBS BSc FRCS PhD
Phone
02033117317
Email
tristan.lane@imperial.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Sasha K Smith, BSc
Email
sasha.smith@imperial.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alun H Davies, MA DM DSC FRCS FEBVS
Organizational Affiliation
Imperial College London
Official's Role
Study Chair
Facility Information:
Facility Name
Imperial College London
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tristan R Lane, PhD FRCS
Email
tristan.lane@imperial.ac.uk
First Name & Middle Initial & Last Name & Degree
Sasha Smith, BSc
Email
sasha.smith@imperial.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Available on request.

Learn more about this trial

Neuromuscular Electrical Stimulation For The Treatment of Diabetic Neuropathy

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