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Active, Not Recruiting

NCT Number: NCT03767478

Neuromuscular Electrical Stimulation For The Treatment of Diabetic Neuropathy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetic Peripheral Neuropathy Diabetes Complications Diabetes Mellitus Diabetic Complication Diabetic Neuropathies Diabetic Polyneuropathy Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imperial College London

London, W6 8RF, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Revitive Medic Coach (Actegy Ltd)

Device

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

Sham Revitive Medic Coach (Actegy Ltd)

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Feasibility outcome measure: recruitment rate measured using screening and randomisation logs.

    Time frame: Pre-screening / Identification, Recruitment and Consent, Baseline

  2. Feasibility outcome measure: participant retention rate measured using randomisation and withdrawal logs.

    Time frame: Recruitment and Consent, Baseline, Week 12, Week 26

  3. Feasibility outcome measure: adherence to treatment measured using Revitive App and a patient diary.

    Time frame: Week 12

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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).

  9. 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).

  10. 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).

  11. 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).

  12. 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.

  13. Secondary outcome measure: blood glucose measured using HbA1c.

    Time frame: Week 12

  14. Secondary outcome measure: mobility and balance measured using validated Berg Balance Scale (BBS).

    Time frame: Week 12, Week 26

  15. Secondary outcome measure: neuropathy signs measured using validated screening questionnaire, Michigan Neuropathy Screening Instrument (MNSI) Part B questionnaire.

    Time frame: Week 12, Week 26

  16. Secondary outcome measure: symptoms measured using Total Symptom Score (TSS).

    Time frame: Week 12

  17. Secondary outcome measure: protected sensation measured using monofilament test.

    Time frame: Week 12, Week 26

  18. Secondary outcome measure: neuropathic pain measured using Neuropathic Pain Symptom Inventory (NPSI).

    Time frame: Week 12, Week 26

  19. Secondary outcome measure: device sensation measured using device sensory threshold and suprathreshold.

    Time frame: Week 12, Week 26

  20. Secondary outcome measure: device experience measured using device experience questionnaire.

    Time frame: Week 12

  21. Secondary outcome measure: device credibility and expectancy measured using modified credibility and expectancy questionnaire.

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Actegy Ltd.

Registry information

Official study title

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

Acronym: NMES-DN

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 6, 2018
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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