Electrical Vestibular Nerve Stimulation (VeNS) Compared to Sham Control As a Means of Improving Glycemic Control in Adults with Type 2 Diabetes Mellitus

Summary

Trial Title A randomized, double blind sham controlled clinical trial to evaluate the efficacy of vestibular nerve stimulation (VeNS), together with a lifestyle modification program, compared to a sham control with a lifestyle modification program, as a means of improving glycemic control in adults with type 2 diabetes mellitus.

The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS), together with a lifestyle modification program, as a method of reducing HbA1c, as compared to a sham control.

Allocation: Randomized to either active device or control device usage. All subjects will receive the same lifestyle advice.

Endpoint classification: Efficacy Study Intervention Model: Parallel Assignment in 1:1 active to control allocation Trial Participants: Those who have been diagnosed with Type 2 diabetes mellitus.

Planned Trial Period: The study will last 24 weeks in total for each subject. The primary analysis will be conducted at the 24 weeks timepoint.

Conditions

• Type 2 Diabetes

Interventions

DEVICE

Vestal DM Active device

Battery powered non-invasive neurostimulation device

BEHAVIORAL

Lifestyle modification

Subjects are prescribed a low calorie (500kcal deficit) diet if their BMI is ≥25. If a subject has a BMI of ≤24.9, they will be provided with guidance on ensuring their recommended daily dietary intake is achieved throughout the course of the trial (i.e 2,500kcal/day for men and 2,000kcal/day for women)

DEVICE

Vestal DM Sham device

Placebo comparator sham device (no active stimulation)

Sponsors & Collaborators

• University College Dublin

  collaborator OTHER

• CS Lifescience

  collaborator UNKNOWN

• Clinical Trial Mentors

  collaborator INDUSTRY

• Neurovalens Ltd.

  lead INDUSTRY

Principal Investigators

• Erik Viirre, MD PhD · UC San Diego

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

22 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-21

Primary Completion

2024-08-06

Completion

2024-08-06

Countries

• United States
• Ireland

Study Locations