Clinical trial NCT03767478: Neuromuscular Electrical Stimulation For The Treatment of Diabetic Neuropathy
Official title: Neuromuscular Electrical Stimulation For The Treatment Of Diabetic Neuropathy: A Multicentre, Double-blind, Pilot, Randomised, Sham-controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetic Peripheral Neuropathy
Diabetic Neuropathies
Diabetic Polyneuropathy
Diabetic Complication
Keywords: Neuromuscular electrical stimulation
Nerve conduction
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Actegy Ltd.
First posted: 2018-12-06
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 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

Primary outcomes:
measure: Primary outcome measure: neuropathy symptoms measured using validated screening questionnaire, Michigan Neuropathy Screening Instrument (MNSI) Part A questionnaire.
timeFrame: Week 6, Week 12, Week 26
Secondary outcomes:
measure: Feasibility outcome measure: recruitment rate measured using screening and randomisation logs.
timeFrame: Pre-screening / Identification, Recruitment and Consent, Baseline
measure: Feasibility outcome measure: participant retention rate measured using randomisation and withdrawal logs.
timeFrame: Recruitment and Consent, Baseline, Week 12, Week 26
measure: Feasibility outcome measure: adherence to treatment measured using Revitive App and a patient diary.
timeFrame: Week 12
measure: Safety outcome measure: Adverse Events (AEs) collected and reported via AE form.
timeFrame: Baseline, Week 3, Week 6, Week 9, Week 12, Week 26 (and any communication in between)
measure: Safety outcome measure: Adverse Device Effects (ADEs) collected and reported via AE form.
timeFrame: Baseline, Week 3, Week 6, Week 9, Week 12, Week 26 (and any communication in between)
measure: Safety outcome measure: Serious Adverse Events (SAEs) collected and reported via SAE form.
timeFrame: Baseline, Week 3, Week 6, Week 9, Week 12, Week 26 (and any communication in between)
measure: Safety outcome measure: Serious Adverse Device Effects (SADEs) collected and reported via SAE form.
timeFrame: Baseline, Week 3, Week 6, Week 9, Week 12, Week 26 (and any communication in between)
measure: Secondary outcome measure: sural nerve conductivity measured using a nerve conduction study (central site only).
timeFrame: Week 12, Week 26.
measure: Secondary outcome measure: superficial peroneal nerve conductivity measured using a nerve conduction study (central site only).
timeFrame: Week 12, Week 26
measure: Secondary outcome measure: common peroneal nerve conductivity measured using a nerve conduction study (central site only).
timeFrame: Week 12, Week 26
measure: Secondary outcome measure: tibial nerve conductivity measured using a nerve conduction study (central site only).
timeFrame: Week 12, Week 26
measure: Secondary outcome measure: somatosensory nerve fibre function measured using QuantitativeSensory Testing (QST) (central site only).
timeFrame: Week 12, Week 26
measure: Secondary outcome measure: blood glucose measured using HbA1c.
timeFrame: Week 12
measure: Secondary outcome measure: mobility and balance measured using validated Berg Balance Scale (BBS).
timeFrame: Week 12, Week 26
measure: Secondary outcome measure: neuropathy signs measured using validated screening questionnaire, Michigan Neuropathy Screening Instrument (MNSI) Part B questionnaire.
timeFrame: Week 12, Week 26
measure: Secondary outcome measure: symptoms measured using Total Symptom Score (TSS).
timeFrame: Week 12
measure: Secondary outcome measure: protected sensation measured using monofilament test.
timeFrame: Week 12, Week 26
measure: Secondary outcome measure: neuropathic pain measured using Neuropathic Pain Symptom Inventory (NPSI).
timeFrame: Week 12, Week 26
measure: Secondary outcome measure: device sensation measured using device sensory threshold and suprathreshold.
timeFrame: Week 12, Week 26
measure: Secondary outcome measure: device experience measured using device experience questionnaire.
timeFrame: Week 12
measure: Secondary outcome measure: device credibility and expectancy measured using modified credibility and expectancy questionnaire.
timeFrame: Baseline
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College London
Study officials:
affiliation: Imperial College London
name: Alun H Davies, MA DM DSC FRCS FEBVS
role: STUDY_CHAIR
References: