Diabetic Complication, Diabetic Neuropathies, Diabetic Peripheral Neuropathy, Diabetic Polyneuropathy
Conditions
Keywords
Neuromuscular electrical stimulation, Nerve conduction
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.
Interventions
DEVICERevitive 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).
DEVICESham 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).
Sponsors
Actegy Ltd.
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure: neuropathy symptoms measured using validated screening questionnaire, Michigan Neuropathy Screening Instrument (MNSI) Part A questionnaire. | Week 6, Week 12, Week 26 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility outcome measure: participant retention rate measured using randomisation and withdrawal logs. | Recruitment and Consent, Baseline, Week 12, Week 26 | — |
| Feasibility outcome measure: adherence to treatment measured using Revitive App and a patient diary. | Week 12 | — |
| Safety outcome measure: Adverse Events (AEs) collected and reported via AE form. | 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. | 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. | 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. | 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). | Week 12, Week 26. | Nerve conduction parameters include sural nerve conduction velocity (m/s) and SNAP amplitude (µV). |
| Secondary outcome measure: superficial peroneal nerve conductivity measured using a nerve conduction study (central site only). | Week 12, Week 26 | 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 (central site only). | 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). |
| Secondary outcome measure: tibial nerve conductivity measured using a nerve conduction study (central site only). | 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). |
| Feasibility outcome measure: recruitment rate measured using screening and randomisation logs. | Pre-screening / Identification, Recruitment and Consent, Baseline | — |
| Secondary outcome measure: blood glucose measured using HbA1c. | Week 12 | — |
| Secondary outcome measure: mobility and balance measured using validated Berg Balance Scale (BBS). | Week 12, Week 26 | — |
| Secondary outcome measure: neuropathy signs measured using validated screening questionnaire, Michigan Neuropathy Screening Instrument (MNSI) Part B questionnaire. | Week 12, Week 26 | — |
| Secondary outcome measure: symptoms measured using Total Symptom Score (TSS). | Week 12 | — |
| Secondary outcome measure: protected sensation measured using monofilament test. | Week 12, Week 26 | — |
| Secondary outcome measure: neuropathic pain measured using Neuropathic Pain Symptom Inventory (NPSI). | Week 12, Week 26 | — |
| Secondary outcome measure: device sensation measured using device sensory threshold and suprathreshold. | Week 12, Week 26 | — |
| Secondary outcome measure: device experience measured using device experience questionnaire. | Week 12 | — |
| Secondary outcome measure: device credibility and expectancy measured using modified credibility and expectancy questionnaire. | Baseline | — |
| Secondary outcome measure: somatosensory nerve fibre function measured using QuantitativeSensory Testing (QST) (central site only). | 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. |
Countries
United Kingdom
Outcome results
None listed