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

Imperial College London

Status: Active, not recruiting

Conditions: Diabetic Polyneuropathy; Diabetic Neuropathies; Diabetic Complication; Diabetic Peripheral Neuropathy

Treatments: Device: Revitive Medic Coach (Actegy Ltd); Device: Sham Revitive Medic Coach (Actegy Ltd)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03767478

NRES REC ID (Other Identifier)

IRAS ID (Other Identifier)

18HH4610

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

65 participants in 2 patient groups

Control group

Sham Comparator group

Description:

Standard of Care + Sham Revitive Medic Coach (Sham Neuromuscular Electrical Stimulation Device) for 12 weeks

Treatment:

Device: Sham Revitive Medic Coach (Actegy Ltd)

Intervention group

Active Comparator group

Description:

Standard of Care + Revitive Medic Coach (Neuromuscular Electrical Stimulation Device) for 12 weeks

Treatment:

Device: Revitive Medic Coach (Actegy Ltd)