ObesityVeSTALNCT03640286
Vestibular Stimulation to Trigger Adipose Loss (VeSTAL) Clinical Trial
A study testing VeSTAL in people with Obesity, run by Neurovalens Ltd. at 4 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- VeSTAL
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 241 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 23 Aug 2019to 26 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Body mass index BMI ≥ 27 kg/m2.
- Males or Females. Note females of child-bearing potential must have a negative urine pregnancy test at screen and also just before each DXA scan. (As DXA involves a small dose of ionizing radiation). They should agree to follow a physician-approved contraceptive regimen for the duration of the study period (other than DMPA injections as this causes weight gain).
- 22-80 years of age inclusive on starting the study. (In order to comply with FDA guidance: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089740.htm#s6)
- Ability and willingness to complete all study visits and procedures; in particular an agreement to engage with: trying to use the device on a daily basis; the hypocaloric diet weight loss program; and this provided weight loss support and mentoring.
- Agreement not to use of prescription, or over-the-counter, weight loss preparations for the duration of the trial.
- Agreement not to start smoking tobacco or marijuana
Who cannot join
- History of vestibular dysfunction or other inner ear disease as indicated by the screening questions.
- History of bariatric surgery, or gastric resection.
- History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
- History of weight loss device implantation (e.g. VBloc Maestro or Abiliti).
- Use of a non-invasive weight loss device (e.g. Modius)
- Hypothyroidism requiring current treatment with levothyroxine (e.g. Levo-T, Synthroid, Thyroxine) (Other thyroid disorder patients on stable treatment for at least 3 months are acceptable).
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- Other endocrinological causes of weight gain (e.g. Cushing's disease, Cushing's syndrome or acromegaly)
- Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent VeNS from working).
- Diagnosis of cirrhosis, chronic pancreatitis, or liver, kidney or heart failure.
- Treatment with prescription weight-loss drug therapy in the 6 months before starting the study.
- Tobacco smoking (including vaping) in the six months prior to starting and for the duration of the study.
- Use of marijuana (smoking, vaping or in edible form) more than twice a month on average.
- Known genetic cause of obesity (e.g., Prader-Willi Syndrome).
- Body weight change of more than 20% in either direction within the previous year.
- Physician-prescribed diet, and/ or current, active member of an organized weight loss program.
- Diabetes mellitus (Types 1 \& 2).
- Diagnosis of epilepsy or use of anti-epileptic medication within six months of starting the study (e.g. for the treatment of peripheral neuropathy)
- Chronic (more than a month of daily use) treatment with opioid analgesic drugs within the last 6 months.
- Regular use (more than twice a month) of anti-histamine medication within the last 6 months.
- Use of oral or intravenous corticosteroid medication within 6 months of starting the study.
- Use of the beta-blockers atenolol, metoprolol or propranolol within 3 months of starting the study.
- Current alterations in treatment regimens of anti-depressant medication for whatever reason (including tricyclic antidepressants) (Note: stable treatment regimen for prior 6 months acceptable).
- An active diagnosis of cancer.
- A myocardial infarction within the preceding year.
- A history of stroke or severe head injury (as defined by a head injury that required craniotomy or endotracheal intubation). (In case this damaged the neurological pathways involved in vestibular stimulation).
- Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.).
- Psychiatric disorders (including untreated severe depression, schizophrenia, substance abuse, eating disorder etc.)
- Current participant in another weight loss study or other clinical trial.
- Have a family member who is currently participating or is planning to participate in this study.
- Weight over 350 pounds at UU, TDE and CTRI site (as this is the weight limit of the DXA scanner) or a weight over 500 pounds at the EPARC site (as this is the weight limit of the DXA scanner)
- Pregnancy The decision to exclude participants with type 2 diabetes mellitus was made after reading the FDA's draft guidance (see: http://www.fda.gov/downloads/Drugs/.../Guidances/ucm071612.pdf). This notes that, "[c]compared with nondiabetic patients, overweight and obese patients with type 2 diabetes often respond less favorably to weight-management products and may face unique safety issues such as risk for sulfonylurea-induced hypoglycemia following weight loss (if the dose of sulfonylurea is not appropriately lowered or the drug discontinued)." The FDA then go on to advise "examining the efficacy and safety of weight-management products in trials dedicated to patients with type 2 diabetes." On the basis of this advice we made the decision to exclude patients with type 2 diabetes. This is an important patient group of course, and our intention is to investigate type 2 diabetics in due course.
- If a subject is found to possibly have type 2 diabetes during the initial screening, then they will be excluded and asked to notify their primary care physician. However, if a subject passes the initial screening but a suspicion of this diagnosis arises during one of the study tests, then the subject will be asked to notify their primary care physician, though they will still be allowed to complete the study.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Texas Diabetes and Endocrinology
Austin, Texas, 78749
UC San Diego, Exercise and Physical Activity Resource Center
La Jolla, California, 92093
University of California San Diego, Altman Clinical & Translational Research Institute,
La Jolla, California, 92093
About this study
Official title: Clinical Investigation Protocol for the Demonstration of Safety and Efficacy of VeSTAL Weight Loss Device in Human Subjects. Randomized Study of VeSTAL in Patients Who Are Overweight
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.
The purpose of this investigation device study is to collect data to support regulatory submissions, primarily in the United States of America (USA), but it may also be used to support submissions in other regions, including the European Union (EU).
Read the detailed description
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 excess body weight and body fat, as compared to a sham control with both study arms incorporating a lifestyle modification program.
- Allocation: Randomized
- Endpoint classification: Efficacy Study
- Intervention Model: Parallel Assignment in 1:1 active to control allocation
- The aim of the study is to recruit a total (i.e. across all 4 sites) of 200 participants that pass the screening process and are randomized into the treatment protocols. With a dropout allowance of 10% this should generate a minimum of 90 active treatment and 90 control subjects.
- Masking: Double Blind (Subject, Nursing staff, Dietician, Co-coordinators, Outcomes Assessor and any other study staff who have contact with the subject)
- Data from all sites will be collated at the end of the studies and analysis will be performed on one data set.
This protocol governs the activities at both the USA and NI/UK clinical sites.
- Conditions
- Obesity
- Being tested
- VeSTAL
- Keywords
- Overweight, Metabolic syndrome, Weight loss, Diet, Atherogenic index, Prediabetes
- Medical subject headings
- Obesity, Overweight, Metabolic Syndrome, Weight Loss, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VeSTALDevice
The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation in combination with a lifestyle modification program, as a method of reducing excess body weight and body fat, as compared to a sham device in combination with the same lifestyle modification program.
| Study group | Role | What they receive |
|---|---|---|
| VeSTAL - active device | Active comparator | The VeSTAL device utilizes a technology called galvanic vestibular stimulation (GVS) (sometimes termed vestibular nerve stimulation (VeNS)). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day. Receives: Device: VeSTAL |
| Sham device | Sham comparator | The sham device looks identical to the active device and interacts with the app in a similar manner to the active device. However, it does not deliver vestibular stimulation to users. The device will be placed on the head in a manner analogous to headphones with hydrogel electrodes placed over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day. Receives: Device: VeSTAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change of Weight From Baseline
The mean percentage weight loss achieved by the Vestal active device in comparison to the sham device
Measured: From baseline to 6 months
Categorical: Proportion of Participants Who Lose 5% Total Body Weight
The proportion of participants who lose 5% total body weight or more in the active Vestal group is at least 50%, independent of the sham control
Measured: 6 months
Secondary outcomes (7)
Mean Percent Loss of Baseline Visceral Adipose Tissue
The difference in mean percent loss of baseline visceral adipose tissue in the active versus placebo treated groups. (As measured by a whole body DXA scan).
Measured: % change in VAT mass at 6 months
Percentage Fat Loss
Percentage fat loss from baseline. (As measured by means of a whole body DXA scan).
Measured: Percentage change from baseline to 6 months
Difference in Lean Muscle Mass in the Active Versus Placebo Treated Group
Difference in lean muscle mass (in kilograms) in the active versus placebo treated group. (As measured by the whole body DXA scan).
Measured: Absolute change at 3 months and 6 months
Atherogenic Index
The Atherogenic Index is calculated using the lipid profile by determining the ratio of Total Cholesterol (TC) to High-Density Lipoprotein (HDL) cholesterol.
If the ratio has been transformed (e.g., natural log-transformed or log10), this will be explicitly stated in the analysis, and the Unit of Measure will reflect this transformation as "log(ratio)" or "ln(ratio)" accordingly.
Measured: Absolute change from baseline to 6 months
Systemic Inflammation
Systemic inflammation is assessed using high-sensitivity C-reactive protein (hs-CRP) levels, measured in milligrams per liter (mg/L). This outcome measure represents the percentage change in hs-CRP levels from baseline to 6 months.
Higher or lower percentage changes indicate increases or decreases in systemic inflammation, respectively. Values are reported as the mean percentage change with standard deviation (SD) for each group.
Measured: Percentage change from baseline to 6 months
Total Energy Intake (kcal)
Total Energy intake (kcal) as assessed by two-day 24 hour dietary recall.
Measured: Change from baseline to 6 months
Quality of Life Ratings
Quality of life was assessed using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire, a validated self-report measure designed to assess obesity-specific quality of life in adults. Scores range from 0 to 100, with higher scores indicating better quality of life.
The outcome measure reflects the absolute change in IWQOL-Lite total scores from baseline to 6 months (i.e., IWQOL-Lite score at 6 months minus IWQOL-Lite score at baseline). Results are reported as the mean absolute change with standard deviation for each study arm.
Measured: Absolute change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start23 Aug 2019
- Primary completion26 Apr 2022
- Study completion26 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurovalens Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Diego, University of Ulster, Exploristics, Compliance Solutions Ltd.
- Responsible party
- Sponsor
- Investigators
- Erik Viirre, MD PhD, Principal investigator, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640286
- Sponsor's protocol ID
- 243973
- Acronym
- VeSTAL
- Status last verified
- Feb 2025
- First submitted
- 13 Aug 2018
- Last updated
- 12 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data will be transferred in an encrypted PDF format. Trial staff will be given direction on how to share the trial data and given access to one specific section of a controlled cloud service which is controlled via role based access. Once they have authenticated with the service and the service verifies that they have the correct role to access the system they will be directed to a single webpage within the application where they will be able to upload the encrypted PDF. This PDF is generated on the fly and is therefore not stored in another location that could become compromised. Generating the PDF on the fly means that the source data is extracted from the database, processed and delivered in the context of a single request. These data will be transferred for each subject when they complete participation in the study.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation Protocol for the Demonstration of Safety and Efficacy of VeSTAL Weight Loss Device in Human Subjects. Randomized Study of VeSTAL in Patients Who Are Overweight
- ClinicalTrials.gov ID
- NCT03640286
- Acronym / sponsor ID
- VeSTAL / 243973
- Conditions
- Obesity
- Keywords
- Overweight, Metabolic syndrome, Weight loss, Diet, Atherogenic index, Prediabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Neurovalens Ltd.Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Diego, University of Ulster, Exploristics, Compliance Solutions Ltd.
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 26 Apr 2022 (actual)
- Study completion
- 26 Apr 2022 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Posted 12 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The purpose of this investigation device study is to collect data to support regulatory submissions, primarily in the United States of America (USA), but it may also be used to support submissions in other regions, including the European Union (EU).
Detailed description
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 excess body weight and body fat, as compared to a sham control with both study arms incorporating a lifestyle modification program.
- Allocation: Randomized
- Endpoint classification: Efficacy Study
- Intervention Model: Parallel Assignment in 1:1 active to control allocation
- The aim of the study is to recruit a total (i.e. across all 4 sites) of 200 participants that pass the screening process and are randomized into the treatment protocols. With a dropout allowance of 10% this should generate a minimum of 90 active treatment and 90 control subjects.
- Masking: Double Blind (Subject, Nursing staff, Dietician, Co-coordinators, Outcomes Assessor and any other study staff who have contact with the subject)
- Data from all sites will be collated at the end of the studies and analysis will be performed on one data set.
This protocol governs the activities at both the USA and NI/UK clinical sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VeSTAL - active device | Active comparator | Device: VeSTALThe VeSTAL device utilizes a technology called galvanic vestibular stimulation (GVS) (sometimes termed vestibular nerve stimulation (VeNS)). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day. |
| Sham device | Sham comparator | Device: VeSTALThe sham device looks identical to the active device and interacts with the app in a similar manner to the active device. However, it does not deliver vestibular stimulation to users. The device will be placed on the head in a manner analogous to headphones with hydrogel electrodes placed over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day. |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent
- Body mass index BMI ≥ 27 kg/m2.
- Males or Females. Note females of child-bearing potential must have a negative urine pregnancy test at screen and also just before each DXA scan. (As DXA involves a small dose of ionizing radiation). They should agree to follow a physician-approved contraceptive regimen for the duration of the study period (other than DMPA injections as this causes weight gain).
- 22-80 years of age inclusive on starting the study. (In order to comply with FDA guidance: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089740.htm#s6)
- Ability and willingness to complete all study visits and procedures; in particular an agreement to engage with: trying to use the device on a daily basis; the hypocaloric diet weight loss program; and this provided weight loss support and mentoring.
Key exclusion criteria (32 listed)
- History of vestibular dysfunction or other inner ear disease as indicated by the screening questions.
- History of bariatric surgery, or gastric resection.
- History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
- History of weight loss device implantation (e.g. VBloc Maestro or Abiliti).
- Use of a non-invasive weight loss device (e.g. Modius)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VeSTALThe aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation in combination with a lifestyle modification program, as a method of reducing excess body weight and body fat, as compared to a sham device in combination with the same lifestyle modification program. | Device | Sham device, VeSTAL - active device |
Primary outcome
Percentage Change of Weight From Baseline
Time frame: From baseline to 6 months
The mean percentage weight loss achieved by the Vestal active device in comparison to the sham device
Categorical: Proportion of Participants Who Lose 5% Total Body Weight
Time frame: 6 months
The proportion of participants who lose 5% total body weight or more in the active Vestal group is at least 50%, independent of the sham control
7 secondary outcomes
Mean Percent Loss of Baseline Visceral Adipose Tissue
Time frame: % change in VAT mass at 6 months
Percentage Fat Loss
Time frame: Percentage change from baseline to 6 months
Difference in Lean Muscle Mass in the Active Versus Placebo Treated Group
Time frame: Absolute change at 3 months and 6 months
Atherogenic Index
Time frame: Absolute change from baseline to 6 months
Systemic Inflammation
Time frame: Percentage change from baseline to 6 months
Total Energy Intake (kcal)
Time frame: Change from baseline to 6 months
Quality of Life Ratings
Time frame: Absolute change from baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data will be transferred in an encrypted PDF format. Trial staff will be given direction on how to share the trial data and given access to one specific section of a controlled cloud service which is controlled via role based access. Once they have authenticated with the service and the service verifies that they have the correct role to access the system they will be directed to a single webpage within the application where they will be able to upload the encrypted PDF. This PDF is generated on the fly and is therefore not stored in another location that could become compromised. Generating the PDF on the fly means that the source data is extracted from the database, processed and delivered in the context of a single request. These data will be transferred for each subject when they complete participation in the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Viirre, MD PhD principal investigator
UC San Diego
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VeSTAL in people with Obesity, run by Neurovalens Ltd. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change of Weight From Baseline (time frame: From baseline to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.