Feasibility of Self-treatment of Painful Diabetic Neuropathy Using Electrical Vasomotor Nerve Stimulation

Not Applicable

Recruiting

• Conditions: Painful Diabetic Neuropathy
• Interventions: Device: Releaf

• Registration Number: NCT06524284
• Lead Sponsor: Neurecon BV

Brief Summary

Electrical stimulation with EVNS (Electrical Vasomotor Neuro Stimulation), a methodology used by a specific group of neurostimulators known under various names, has proven its benefit in Painful Diabetic Neuropathy (PDN). However, due to the impaired mobility from Diabetic Neuropathy, a part of subjects did not finish the 10 days treatment in the outpatient clinic. Another part of the target group decided not to participate at all for the same reason.

The current study investigates the feasibility, safety and performance of a newly developed EVNS device, called Releaf™, optimised for HOME treatment,

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-22
• Study First Submitted: 2024-07-23
• Study First Submitted QC: 2024-07-23
• Study First Posted: 2024-07-29
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-16
• Primary Completion: 2024-11
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Painful Diabetic Neuropathy (DN4 positive) and insufficiently treated with any combination of 2 of the following drugs: Duloxetine (Cymbalta), venlafaxine (Efexor), ami- or nortriptyline, gabapentine, pregabaline (Lyrica) or the use of carbamazepine or capsaïcine (Qutenza).
• Both feet are present
• Able and willing to complete the treatments in 10 days in a row and completion of questionnaires.
• Being in a mental and physical state to perform home self-treatment with Releaf™ for 10 consecutive days, if necessary with adequate assistance of caregiver.
• Being in a mental and physical state to understand and complete the informed consent form as well as the research questionnaires.

Exclusion Criteria

• In case of other evident causes for painful neuropathy,
• Currently participating in another interventional investigational study
• Significant peripheral arterial disease,
• Active foot ulceration or other skin conditions that prevent the application of electrodes on the skin
• Current alcohol or other substance abuse (use of alcohol over the recommended limits of less than 21 units of alcohol per week in men and 14 units in women, Trimbos Intitute),
• Epilepsy,
• Pregnancy,
• Presence of a medical device based on electrical stimulation, cardiac pacemaker and/or implantable cardioverter defibrillator or any other active implant
• Allergy to electrode contact area or to the adhesive substance of the electrode.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EVNS treatment	Releaf	EVNS, see intervention

Primary Outcome Measures

Name	Time	Method
Reported usability	Day 10	Usability by the User Questionnaire
Side-effects	Day 1-10	The number and severity of reported side-effects of HOME-EVNS, gathered via telephonic consulting on treatment day 1,3 and 8 and via user-initiated incoming calls to the PI
Use of helpdesk	Day 1-10	The number of help requests to service desk.
Successful treatment cycles	Day 11	The successful treatment cycles applied at home, defined as cycles with at least 8/10 successful (full 35 minutes) treatment sessions, derived from the adherence determined by recording device usage and intensity setting which is downloaded from device after its retrieval

Secondary Outcome Measures

Name	Time	Method
Quality of life score	Before start, after 1 month, after 3 months	EuroQol 5 Dimension 5 Level (EQ-5D-5L) QoL filled in by subject
Neuropathic pain	Before start, after 1 month, after 3 months	Neuropathic Pain Symptom Inventory (NPSI) filled in by subject

Trial Locations

Locations (1)

Neurecon; 🇳🇱 Vught, Netherlands