Vestibular Stimulation to Trigger Apidose Loss (VeSTAL) Clinical Trial
Research type
Research Study
Full title
This is a randomized, double blind sham controlled clinical trial to evaluate the efficacy of vestibular nerve stimulation (VeNS), combined with a lifestyle modification program, compared to a sham control and a lifestyle modification program as a means of reducing excess body weight and body fat.
IRAS ID
243973
Contact name
Edwin Lindsay
Contact email
Sponsor organisation
Compliance Solutions
Eudract number
2018-002106-31
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Research Summary
There is an ongoing and worsening problem with obesity in the developed, and much of the developing world. Although it has long been realized that Western diets that are rich in sugar and fat play an important role in this, it has only recently been realized that exposure to these diets, particularly in childhood, can damage the part of the brain that determines how much fat there is in the body. The result of this damage is that the so-called “set-point” for fat in this part of the brain is pushed upwards. There is a lot of evidence from animal studies that activating the brain’s balance (vestibular) system pushes this set-point for fat downwards to cause fat loss, probably because this tricks the brain into thinking that the animal is more physically active.
The aim of this study is to determine whether the same effect can be triggered in humans by non-invasively stimulating the vestibular system with a small electrical current through the skin behind their ears, in order to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS), together with a lifestyle modification program, as a method of reducing excess body weight and fat, as compared to a sham control and lifestyle modification program.
In the proposed study subjects, who are overweight will self-administer VeNS or sham stimulation at home for a total of at least 5 hours a week. If they wish the subjects can use the devices for up to 7 hours a week, they cannot use the device for longer as the device has a locking system. The subjects will visit a controlled clinical site on 4 occasions over a duration of 12 months for various testing procedures in relation to weight and fat loss.
Summary of Results
Title
A randomized, double blind sham controlled clinical trial to evaluate the efficacy of vestibular nerve stimulation (VeNS), combined with a lifestyle modification program, compared to a sham control and a lifestyle modification program as a means of reducing excess body weight and body fat.Who carried out the research?
• Chief Investigator: Dr Erik Virre, Departments of Neurosciences, University of California San Diego, US.
• Sponsor: Neurovalens Limited, Belfast, UK.
• Research sites: Please see section “Where and when the study took place?”.Why was the research needed?
There is an ongoing and worsening problem with obesity in the developed, and much of the developing world. Although it has long been realised that Western diets that are rich in sugar and fat play an important role in this, it has only recently been realised that exposure to these diets, particularly in childhood, can damage the part of the brain that determines how much fat there is in the body. The result of this damage is that the so-called “set-point” for fat in this part of the brain is pushed upwards. There is a lot of evidence from animal studies that activating the brain’s balance (vestibular) system pushes this set-point for fat downwards to cause fat loss, probably because this tricks the brain into thinking that the animal is more physically active. The aim of this study was to determine whether the same effect can be triggered in humans by non-invasively stimulating the vestibular system with a small electrical current through the skin behind their ears.What were the main questions studied?
The primary objective was to evaluate the impact of an electrical vestibular nerve stimulation (VeNS) device called VeSTAL, together with a lifestyle modification program, as a method of reducing excess body weight and fat, as compared to a sham control device and lifestyle modification program.Secondary objectives were to evaluate the safety of the VeSTAL device relative to the sham control device, in terms of the occurrence of adverse events (AEs) and changes from baseline in cardiovascular risk factors and quality of life.
Where and when the study took place?
The study took place from September 2019 to April 2022. There were four research sites, one in the UK at the University of Ulster, and three sites in the USA including the Altman Clinical and Translational Research Institute (ACTRI) and the Exercise and Physical Activity Resource Center (EPARC) at the University of California San Diego, and the Texas Diabetes and Endocrinology (TDE) in Austin. Ethical approval for the study protocol was obtained by all research sites.Who participated in the study?
A total of 241 overweight and obese (BMI ≥27 kg/m2) adults aged 22 or over were recruited by advertising the study on social media, using newspaper adverts, posters, leaflets, and volunteer databases. Participants were screened using an inclusion and exclusion criteria to determine if they were eligible for the trial. All eligible participants provided written informed consent to take part in the study.What treatments or interventions did the participants take/receive?
A computer randomised the participants to the VeSTAL (n=117) and sham control groups (n=124) and both groups were advised to use their device (VeSTAL or Sham) for an hour every day, and at least five times a week for 6 months. The VeSTAL device is a transdermal neurostimulation product. It consists of a battery-powered headset designed to deliver low-level energy in the form of a neurostimulation waveform that modulates the activity of the vestibular cranial nerve. The delivery of this waveform is through two self-adhesive electrode pads. These pads are placed on the skin overlaying each mastoid process. When turned on, the product delivers a small electrical impulse which can be adjusted up or down by the participant.The sham device looked identical to the VeSTAL device to maintain subject blinding; however, the sham device did not deliver clinically meaningful vestibular stimulation to the participant. The device delivered a small electrical current to the skin behind the ears, over the mastoid processes for 30 seconds, before slowly decreasing to 0 mA over a further 20 seconds (total of 50 seconds of stimulation).
Both groups were also provided with the same lifestyle modification program to follow for the duration of the study. This involved the participants receiving advice and counselling from the research dietician which focused on weight loss and healthy eating.
What happened during the study?
Study assessments were carried out at the start of the study (baseline), and after 3 and 6 months of using the device. All baseline assessments were conducted face to face at each research site; however, as a proportion of the study was undertaken during the Covid-19 pandemic, several of the 3- and 6-month appointments were conducted remotely, which prevented some of the clinical assessments being undertaken.Data captured included body weight (kg), body fat (%) measured using a DXA scan, waist circumference (cm), lipid panel (Total Cholesterol (mg/dL), Low Density Lipoprotein, LDL (mg/dL), and High Density Lipoprotein, HDL (mg/dL)), C-Reactive Protein (CRP), total calorie intake, and quality of life. Only body weight and quality of life data were collected at the 3-month appointment.
What were the results of the study?
A total of 241 participants were recruited for the study. At the 6-month time point, 26 (22%) participants who were randomised to the VeSTAL group withdrew from the study, while 35 (28%) of the sham control group withdrew from the study.An intention to treat analysis shows that both the VeSTAL and sham control groups lost weight (kg) from baseline to 6 months; however, the difference between the groups was not significant (-2.91 vs. -2.30, p=0.394; respectively). According to the DXA scan results, both groups lost total body fat; however, the VeSTAL group achieved a higher percentage reduction from baseline in visceral adipose tissue (VAT) at 6 months compared with the sham control group (-12.63 vs. -4.67, p=0.033). Furthermore, a greater proportion of the VeSTAL group compared with the sham control group lost 5% or more of total body fat (44% vs. 30%, p=0.032) as well as 10% or more of visceral adipose tissue at 6 months (49% vs. 35%, p=0.036).
There were no differences in the secondary outcomes among the randomised groups.
The most common adverse events for the VeSTAL device were dizziness, fatigue, headache, ear pain, mild tinnitus, nausea, and skin irritation. The adverse events were all minor, caused a minimal discomfort to participants, and all self-resolved during the period of the study. There were no serious adverse or device events reported during the study.
How will this study help patients?
This study shows the potential VeSTAL has as a low risk, non-invasive method for reducing body fat, specifically visceral adipose tissue. A reduction in visceral adipose tissue of 10% or more can be considered clinically meaningful due to its association with several health improvements and reduced risks for various diseases, even beyond the benefits of overall weight loss.REC name
HSC REC B
REC reference
18/NI/0176
Date of REC Opinion
29 Nov 2018
REC opinion
Further Information Favourable Opinion