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

April 7, 2025 updated by: Imperial College London

Neuromuscular Electrical Stimulation For The Treatment Of Diabetic Neuropathy: A Multicentre, Double-blind, Pilot, Randomised, Sham-controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, W6 8RF
        • Imperial College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 validated screening questionnaire Michigan Neuropathy Screening Instrument score of ≥4
  • Access to internet at home to use the Revitive App (study smartphones will be provided)

EXCLUSION CRITERIA

  • Lacks capacity to provide informed consent
  • Pregnant
  • Implanted electronic, cardiac or defibrillator device
  • Other cause of peripheral neuropathy
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Control group
Standard of Care + Sham Revitive Medic Coach (Sham Neuromuscular Electrical Stimulation Device) for 12 weeks
Device: Sham Revitive Medic Coach (Actegy Ltd)
Use the device for two 30-minute sessions per day, a minimum of five hours per week for 12 weeks at suprathreshold (2 x motor threshold).
Other Names:
  • Sham Footplate Neuromuscular Electrical Stimulation Device
Active Comparator: Intervention group
Standard of Care + Revitive Medic Coach (Neuromuscular Electrical Stimulation Device) for 12 weeks
Device: Revitive Medic Coach (Actegy Ltd)
Use the device for two 30-minute sessions per day, a minimum of five hours per week for 12 weeks at suprathreshold (2 x motor threshold).
Other Names:
  • Footplate Neuromuscular Electrical Stimulation Device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Primary outcome measure: neuropathy symptoms measured using validated screening questionnaire, Michigan Neuropathy Screening Instrument (MNSI) Part A questionnaire.
Time Frame: Week 6, Week 12, Week 26
Week 6, Week 12, Week 26

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Feasibility outcome measure: recruitment rate measured using screening and randomisation logs.
Time Frame: Pre-screening / Identification, Recruitment and Consent, Baseline
Pre-screening / Identification, Recruitment and Consent, Baseline
Secondary outcome measure: device credibility and expectancy measured using modified credibility and expectancy questionnaire.
Time Frame: Baseline
Baseline
Feasibility outcome measure: participant retention rate measured using randomisation and withdrawal logs.
Time Frame: Recruitment and Consent, Baseline, Week 12, Week 26
Recruitment and Consent, Baseline, Week 12, Week 26
Feasibility outcome measure: adherence to treatment measured using Revitive App and a patient diary.
Time Frame: Week 12
Week 12
Safety outcome measure: Adverse Events (AEs) collected and reported via AE form.
Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12, Week 26 (and any communication in between)
Baseline, Week 3, Week 6, Week 9, Week 12, Week 26 (and any communication in between)
Safety outcome measure: Adverse Device Effects (ADEs) collected and reported via AE form.
Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12, Week 26 (and any communication in between)
Baseline, Week 3, Week 6, Week 9, Week 12, Week 26 (and any communication in between)
Safety outcome measure: Serious Adverse Events (SAEs) collected and reported via SAE form.
Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12, Week 26 (and any communication in between)
Baseline, Week 3, Week 6, Week 9, Week 12, Week 26 (and any communication in between)
Safety outcome measure: Serious Adverse Device Effects (SADEs) collected and reported via SAE form.
Time Frame: Baseline, Week 3, Week 6, Week 9, Week 12, Week 26 (and any communication in between)
Baseline, Week 3, Week 6, Week 9, Week 12, Week 26 (and any communication in between)
Secondary outcome measure: sural nerve conductivity measured using a nerve conduction study (central site only).
Time Frame: Week 12, Week 26.
Nerve conduction parameters include sural nerve conduction velocity (m/s) and SNAP amplitude (µV).
Week 12, Week 26.
Secondary outcome measure: superficial peroneal nerve conductivity measured using a nerve conduction study (central site only).
Time Frame: Week 12, Week 26
Nerve conduction parameters include conduction velocity (m/s), calculated using distance and latency (ms), and SNAP amplitude (μV).
Week 12, Week 26
Secondary outcome measure: common peroneal nerve conductivity measured using a nerve conduction study (central site only).
Time Frame: Week 12, Week 26
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).
Week 12, Week 26
Secondary outcome measure: tibial nerve conductivity measured using a nerve conduction study (central site only).
Time Frame: Week 12, Week 26
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).
Week 12, Week 26
Secondary outcome measure: somatosensory nerve fibre function measured using QuantitativeSensory Testing (QST) (central site only).
Time Frame: Week 12, Week 26
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.
Week 12, Week 26
Secondary outcome measure: blood glucose measured using HbA1c.
Time Frame: Week 12
Week 12
Secondary outcome measure: mobility and balance measured using validated Berg Balance Scale (BBS).
Time Frame: Week 12, Week 26
Week 12, Week 26
Secondary outcome measure: neuropathy signs measured using validated screening questionnaire, Michigan Neuropathy Screening Instrument (MNSI) Part B questionnaire.
Time Frame: Week 12, Week 26
Week 12, Week 26
Secondary outcome measure: symptoms measured using Total Symptom Score (TSS).
Time Frame: Week 12
Week 12
Secondary outcome measure: protected sensation measured using monofilament test.
Time Frame: Week 12, Week 26
Week 12, Week 26
Secondary outcome measure: neuropathic pain measured using Neuropathic Pain Symptom Inventory (NPSI).
Time Frame: Week 12, Week 26
Week 12, Week 26
Secondary outcome measure: device sensation measured using device sensory threshold and suprathreshold.
Time Frame: Week 12, Week 26
Week 12, Week 26
Secondary outcome measure: device experience measured using device experience questionnaire.
Time Frame: Week 12
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Imperial College London

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Actegy Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Alun H Davies, MA DM DSC FRCS FEBVS, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 22, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18HH4610
  • IRAS ID (Other Identifier: 23712)
  • NRES REC ID (Other Identifier: 18/NE/0281)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Available on request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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