Vestal DM
Research type
Research Study
Full title
A randomised, 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 glycaemic control in adults with type 2 diabetes mellitus.
IRAS ID
310090
Contact name
Leigh-Ann McCrum
Contact email
Sponsor organisation
Neurovalens
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 31 days
Research summary
There is a growing realisation that metabolic syndrome and its associated diseases, including type 2 diabetes mellitus (DM) and obesity can, in many ways, be viewed as a neurological disease. In particular “Western” style diets, that are rich in sugar and saturated fat, have been shown to adversely affect the parts of the brain that control metabolism, leading to excess body fat and problems controlling blood sugar. There is evidence from both animal and human studies that activating the brain’s balance (vestibular) system can act to correct this, leading to a reduction in body fat and an improvement in controlling blood sugar. It is thought this is because repeated stimulation of the vestibular system gives the brain the impression of being in a state of chronic physical activity and in such a state fat and sugar need to be used for energy.
It is possible to stimulate the vestibular system in humans by applying a small electrical current to the skin behind the ears using a technology called vestibular nerve stimulation (VeNS). This is because the vestibular nerve is close to the skin at this point. VeNS is an established and non-invasive technology that is believed to be safe. However, it has only previously been used for research purposes.
Neurovalens, the sponsor of this study, found in a pilot study that repeated use of VeNS for about five hours a week over several months led to a significant improvement in the blood sugar control of a group of patients with type 2 diabetes. This improvement was not seen in the control group who did not receive VeNS treatment. Given the increasing prevalence of type 2 DM, it is important to determine whether VeNS is a viable treatment option. Therefore, the purpose of this study is to evaluate the effectiveness of VeNS, together with a lifestyle modification program, as a method of treating type 2 DM. The study will aim to recruit approximately 200 subjects who will be given a study device for home use.REC name
North of Scotland Research Ethics Committee 1
REC reference
22/NS/0031
Date of REC Opinion
3 Apr 2022
REC opinion
Favourable Opinion