Neuromuscular Electrical Stimulation For The Treatment of Diabetic Neuropathy

Not Applicable

Recruiting

• Conditions: Diabetic Polyneuropathy; Diabetic Complication; Diabetic Neuropathies; Diabetic Peripheral Neuropathy
• Interventions: Device: Sham Revitive Medic Coach (Actegy Ltd); Device: Revitive Medic Coach (Actegy Ltd)

• Registration Number: NCT03767478
• Lead Sponsor: Imperial College London

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-11-27
• Study First Submitted QC: 2018-12-05
• Study First Posted: 2018-12-06
• Study Start: 2023-08-22
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Sham Revitive Medic Coach (Actegy Ltd)	Best Medical Therapy + Sham Revitive Medic Coach (Sham Neuromuscular Electrical Stimulation Device) for 6 months
Intervention group	Revitive Medic Coach (Actegy Ltd)	Best Medical Therapy + Revitive Medic Coach (Neuromuscular Electrical Stimulation Device) for 6 months

Primary Outcome Measures

Name	Time	Method
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).	Month 6	Multi-component, single outcome. Nerve conduction parameters include sural nerve conduction velocity (m/s) and SNAP amplitude (µV).

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measure: superficial peroneal nerve conductivity measured using a nerve conduction study.	Month 6, Month 9	Nerve conduction parameters include conduction velocity (m/s), calculated using distance and latency (ms), and SNAP amplitude (μV).
Safety outcome measure: Serious Adverse Device Effects (SADEs) collected and reported via SAE form.	Baseline, Week 2, Month 6, Month 9 (and any communication in between)
Feasibility outcome measure: adherence to treatment measured using Revitive App and a patient diary.	Month 6
Feasibility outcome measure: recruitment rate measured using screening and randomisation logs.	Pre-screening / Identification, Recruitment and Consent, Baseline
Safety outcome measure: Adverse Events (AEs) collected and reported via AE form.	Baseline, Week 2, Month 6, Month 9 (and any communication in between)
Safety outcome measure: Serious Adverse Events (SAEs) collected and reported via SAE form.	Baseline, Week 2, Month 6, Month 9 (and any communication in between)
Secondary outcome measure: mobility and balance measured using validated Berg Balance Scale (BBS).	Month 6, Month 9
Feasibility outcome measure: participant retention rate measured using randomisation and withdrawal logs.	Recruitment and Consent, Baseline, Month 6
Safety outcome measure: Adverse Device Effects (ADEs) collected and reported via AE form.	Baseline, Week 2, Month 6, Month 9 (and any communication in between)
Secondary outcome measure: common peroneal nerve conductivity measured using a nerve conduction study.	Month 6, Month 9	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.	Month 6, Month 9	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).	Month 6, Month 9	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: neuropathy symptoms measured using validated Self-administered Neuropathy Total Symptom Score (NTSS-6-SA).	Month 6, Month 9
Secondary outcome measure: quality of life measured using validated EQ-5D-5L questionnaire.	Month 6, Month 9
Secondary outcome measure: illness perceptions measured using validated Brief Illness Perception Questionnaire (Brief IPQ).	Month 6, Month 9
Secondary outcome measure: neuropathy signs and symptoms measured using validated screening questionnaire, Michigan Neuropathy Screening Instrument (MNSI).	Month 6, Month 9
Secondary outcome measure: protected sensation measured using monofilament test.	Month 6, Month 9
Secondary outcome measure: device credibility and expectancy measured using modified credibility and expectancy questionnaire.	Baseline
Secondary outcome measure: neuropathic pain measured using Neuropathic Pain Symptom Inventory (NPSI).	Month 6, Month 9
Secondary outcome measure: daily pain measured using 11-point Numerical Rating Scale (NRS) collected via text message.	Daily for treatment phase (6 months)
Secondary outcome measure: daily sleep interference measured using Daily Sleep Interference Scale (DSIS) (30) collected via text message.	Daily for treatment phase (6 months)
Secondary outcome measure: peripheral arterial perfusion measured using Ankle Brachial Pressure Index (ABPI).	Baseline
Secondary outcome measure: device sensation measured using device sensory threshold and suprathreshold.	Month 6, Month 9
Secondary outcome measure: device experience measured using device experience questionnaire.	Month 6

Trial Locations

Locations (1)

Imperial College London; 🇬🇧 London, United Kingdom