ObesityVeSTALNCT03138369
Vestibular Stimulation to Trigger Adipose Loss Clinical Trial
A study testing Vestibular nerve stimulator in people with Obesity and Obesity, Abdominal, run by Neurovalens Ltd. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Obesity, Obesity, Abdominal, Metabolic Syndrome
- What is being tested?
- Vestibular nerve stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2017to 14 Dec 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Body mass index (BMI) ≥ 30 kg/m2, or BMI ≥ 27 kg/m2 with one or more of these obesity related co-morbid conditions:
- History of treatment for systemic hypertension
- History of treatment for dyslipidemia
- History of treatment for sleep apnea syndrome
- Stable cardiovascular disease (no change in medication and no active events within 1 year).
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- 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.
- Ability and willingness to complete all study visits and procedures.
- Owner of a smart phone (iOS or Android) in order to access the diet monitoring and advice app, activity monitoring app, and the app that reports on the status of the stimulation devices used in the study.
- Agreement not to use of prescription drug therapy or the use of over-the-counter weight loss preparations for the duration of the trial.
- Agreement not to start smoking tobacco or marijuana for the duration of the study.
Who cannot join
- History of vestibular dysfunction.
- History of bariatric surgery, fundoplication, gastric resection or major upper-abdominal surgery (acceptable surgeries include cholecystectomy, hysterectomy).
- History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears, or of the head and neck.
- History of weight loss device implantation (e.g. VBloc Maestro or Abiliti), or use of a non-invasive device.
- Untreated thyroid disorder (stable treatment for 3 months is acceptable).
- Other endocrinological causes of weight gain (e.g. Cushing's disease, Cushing's syndrome or acromegaly)
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- Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent VeNS from working).
- History of cirrhosis, or liver, kidney or heart failure.
- Chronic pancreatitis.
- Treatment with prescription weight-loss drug therapy in the year before starting the study.
- Tobacco or marijuana smoking in the year prior to starting and for the duration of the study.
- Known genetic cause of obesity (e.g., Prader-Willi Syndrome).
- Body weight change of more than 10% in either direction within the previous year.
- Physician-prescribed diet, and/ or current, active member of an organized weight loss program (e.g., Weight Watchers). (Note: study subjects may continue any personal eating plan they were on prior to study enrollment)
- Diabetes mellitus (Types 1 \& 2). (See Section 9 Research Design and Methods, Appendix 3)
- 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 year.
- Regular use (more than twice a month) of anti-histamine medication.
- Use of oral or intravenous corticosteroid medication within a year 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 (other than tricyclic antidepressants) (Note: stable treatment regimen for prior six 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 intensive care). (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, bulimia nervosa etc.)
- Current participant in another weight loss study or other clinical trials.
- Have a family member who is currently participating or is planning to participate in this study.
- Subject weighs over 350 pounds as this is the weight limit of the DXA scanner.
Trial locations and contacts
1 site in 1 country.
United States1 site
Altman Clinical and Translation Research Institute, UC San Diego
San Diego, California, 92037
About this study
Official title: Vestibular Stimulation To Trigger Adipose Loss (Vestal) Clinical Trial
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 animals 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 see 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.
Read the detailed description
There is a growing realization that obesity can, in many ways, be viewed as a neurological disease triggered by lifestyle factors. There is clear evidence that the arcuate nucleus in the hypothalamus regulates a "set-point" for how much fat the body should have. It does so by altering appetite and metabolic rate so that deviations too far in either direction are strongly resisted. This set-point is determined by genetic, epigenetic and lifestyle factors. Thus, excessive exposure to dietary monosaccharides, such as glucose, and saturated fats, especially in childhood and adolescence, can damage the neurons of the arcuate nucleus and push the set-point up. This then can condemn sufferers to a lifetime of obesity.
Establishing a method of tuning down the set-point for body fat thus has to be a goal if we are to successfully combat the current obesity pandemic. A significant amount of animal work suggests that stimulating the vestibular system in the inner ear, by means of chronic centrifugation, actually does just that and causes a reduction in body fat. This is likely because the chronic vestibular activation is taken by the brain to represent a state of increased physical activity, and in order to optimize homeostasis it would be appropriate for the body to have a leaner physique, by reducing unnecessary energy expenditure from carrying excess fat.
It is possible to stimulate the vestibular nerve in humans by applying a small electrical current to the skin behind the ears. This is an established technology that is believed to be safe, but only previously used for research purposes. We found in a pilot study that recurrent stimulation of this kind for two or three hours a week over four months led to a statistically significant reduction in truncal fat in the active group as opposed to the control group who underwent sham stimulation.
Given the current, and increasing levels of global obesity, it is important to determine whether non-invasive electrical vestibular nerve stimulation (VeNS), otherwise known as galvanic vestibular stimulation, is a viable treatment option. Changes in body fat will be measured using dual energy X-ray absorptiometry (DEXA) scans.
- Conditions
- Obesity, Obesity, Abdominal, Metabolic Syndrome, Weight Loss
- Being tested
- Vestibular nerve stimulator, Sham vestibular stimulation
- Keywords
- Obesity, Metabolic Syndrome, Prediabetes, Glycemic control, Hypercholesterolemia, Abdominal obesity, Weight Loss
- Medical subject headings
- Obesity, Obesity, Abdominal, Metabolic Syndrome, Weight Loss, Prediabetic State, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular nerve stimulatorDevice
Also called Galvanic vestibular stimulation
Battery powered headset that can be recharged when not being used.
Sham vestibular stimulationDevice
Identical in external appearance to the vestibular nerve stimulation device, this device is also powered by a battery and needs to be periodically recharge when not being used. However it discharges into an internal resistor and does not stimulate the vestibular nerve.
| Study group | Role | What they receive |
|---|---|---|
| Vestibular nerve stimulation | Experimental | Usage of wearable vestibular nerve stimulator that non-invasively stimulates the vestibular nerves by administering a small electrical current through the skin behind the ears. Should be worn up to one hour a day and at least 5 hours a week. Receives: Device: Vestibular nerve stimulator |
| Sham vestibular nerve stimulation | Sham comparator | Usage of wearable control device that appears identical to active device. Instead of stimulating the vestibular nerves this device will discharge its battery into an internal resistor. Should be worn up to one hour a day and at least 5 hours a week. Receives: Device: Sham vestibular stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Body Weight (kg)
Mean total body weight loss (TBWL) from the start of treatment (as a percentage of baseline total body weight). Change = 12 month score - baseline score
Measured: Baseline and 12 months
Change in Categorical Body Weight
Change in Categorical Body Weight measured by BMI:
Normal: 18.5-24.9 Overweight: 25.0-29.0 Obese: >30.0 Average BMI calculated. Change = 12 month score - baseline score
Measured: Baseline and 12 months
Secondary outcomes (4)
Visceral Adipose Tissue
The difference in mean percent loss of baseline visceral adipose tissue (in kilograms) in the vestibular stimulation versus sham stimulation group, as measured by means of a whole body DXA scan. Change = 12 month score - baseline score
Measured: Baseline and 12 months
Lean Muscle
Change in total lean (muscle) mass in kilograms between vestibular stimulation and sham stimulation groups as assessed using whole body DXA scans.
Measured: Baseline and 12 months
Change in Categorical Body Fat
The proportion of subjects who lose at least 5% of baseline total body fat in the active versus placebo treated groups. (As measured by a whole body DXA scan).
Measured: Baseline and 12 months
Change in Mean Body Fat (g)
The difference in mean percent loss of baseline total body fat in the active versus placebo treated groups. (As measured by means of a whole body DXA scan). Change = 12 month score - baseline score
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start6 Nov 2017
- Primary completion14 Dec 2018
- Study completion14 Dec 2018
Why it stopped: High drop out rate due to subjects needing to record details of every meal
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment in 1:1 active to control allocation
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurovalens Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Diego
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138369
- Sponsor's protocol ID
- 170255
- Acronym
- VeSTAL
- Status last verified
- Mar 2022
- First submitted
- 24 Apr 2017
- Last updated
- 27 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular Stimulation To Trigger Adipose Loss (Vestal) Clinical Trial
- ClinicalTrials.gov ID
- NCT03138369
- Acronym / sponsor ID
- VeSTAL / 170255
- Conditions
- Obesity, Obesity, Abdominal, Metabolic Syndrome, Weight Loss
- Keywords
- Obesity, Metabolic Syndrome, Prediabetes, Glycemic control, Hypercholesterolemia, Abdominal obesity, Weight Loss
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: High drop out rate due to subjects needing to record details of every meal
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Neurovalens Ltd.Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Diego
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 14 Dec 2018 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Posted 27 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 animals 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 see 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.
Detailed description
There is a growing realization that obesity can, in many ways, be viewed as a neurological disease triggered by lifestyle factors. There is clear evidence that the arcuate nucleus in the hypothalamus regulates a "set-point" for how much fat the body should have. It does so by altering appetite and metabolic rate so that deviations too far in either direction are strongly resisted. This set-point is determined by genetic, epigenetic and lifestyle factors. Thus, excessive exposure to dietary monosaccharides, such as glucose, and saturated fats, especially in childhood and adolescence, can damage the neurons of the arcuate nucleus and push the set-point up. This then can condemn sufferers to a lifetime of obesity.
Establishing a method of tuning down the set-point for body fat thus has to be a goal if we are to successfully combat the current obesity pandemic. A significant amount of animal work suggests that stimulating the vestibular system in the inner ear, by means of chronic centrifugation, actually does just that and causes a reduction in body fat. This is likely because the chronic vestibular activation is taken by the brain to represent a state of increased physical activity, and in order to optimize homeostasis it would be appropriate for the body to have a leaner physique, by reducing unnecessary energy expenditure from carrying excess fat.
It is possible to stimulate the vestibular nerve in humans by applying a small electrical current to the skin behind the ears. This is an established technology that is believed to be safe, but only previously used for research purposes. We found in a pilot study that recurrent stimulation of this kind for two or three hours a week over four months led to a statistically significant reduction in truncal fat in the active group as opposed to the control group who underwent sham stimulation.
Given the current, and increasing levels of global obesity, it is important to determine whether non-invasive electrical vestibular nerve stimulation (VeNS), otherwise known as galvanic vestibular stimulation, is a viable treatment option. Changes in body fat will be measured using dual energy X-ray absorptiometry (DEXA) scans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment in 1:1 active to control allocation
| Arm | Type | Receives |
|---|---|---|
| Vestibular nerve stimulation | Experimental | Device: Vestibular nerve stimulatorUsage of wearable vestibular nerve stimulator that non-invasively stimulates the vestibular nerves by administering a small electrical current through the skin behind the ears. Should be worn up to one hour a day and at least 5 hours a week. |
| Sham vestibular nerve stimulation | Sham comparator | Device: Sham vestibular stimulationUsage of wearable control device that appears identical to active device. Instead of stimulating the vestibular nerves this device will discharge its battery into an internal resistor. Should be worn up to one hour a day and at least 5 hours a week. |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed informed consent
- Body mass index (BMI) ≥ 30 kg/m2, or BMI ≥ 27 kg/m2 with one or more of these obesity related co-morbid conditions:
- 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.
- Ability and willingness to complete all study visits and procedures.
Key exclusion criteria (29 listed)
- History of vestibular dysfunction.
- History of bariatric surgery, fundoplication, gastric resection or major upper-abdominal surgery (acceptable surgeries include cholecystectomy, hysterectomy).
- History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears, or of the head and neck.
- History of weight loss device implantation (e.g. VBloc Maestro or Abiliti), or use of a non-invasive device.
- Untreated thyroid disorder (stable treatment for 3 months is acceptable).
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 |
|---|---|---|
| Vestibular nerve stimulatorAlso: Galvanic vestibular stimulationBattery powered headset that can be recharged when not being used. | Device | Vestibular nerve stimulation |
| Sham vestibular stimulationIdentical in external appearance to the vestibular nerve stimulation device, this device is also powered by a battery and needs to be periodically recharge when not being used. However it discharges into an internal resistor and does not stimulate the vestibular nerve. | Device | Sham vestibular nerve stimulation |
Primary outcome
Change in Mean Body Weight (kg)
Time frame: Baseline and 12 months
Mean total body weight loss (TBWL) from the start of treatment (as a percentage of baseline total body weight). Change = 12 month score - baseline score
Change in Categorical Body Weight
Time frame: Baseline and 12 months
Change in Categorical Body Weight measured by BMI: Normal: 18.5-24.9 Overweight: 25.0-29.0 Obese: >30.0 Average BMI calculated. Change = 12 month score - baseline score
4 secondary outcomes
Visceral Adipose Tissue
Time frame: Baseline and 12 months
Lean Muscle
Time frame: Baseline and 12 months
Change in Categorical Body Fat
Time frame: Baseline and 12 months
Change in Mean Body Fat (g)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Pilot Study on BiorxivLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular nerve stimulator in people with Obesity and Obesity, Abdominal, run by Neurovalens Ltd. at 1 site in United States.
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 12 inclusion and 29 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: stopped early, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 27 Apr 2022). 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?
Change in Mean Body Weight (kg) (time frame: Baseline and 12 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 27 Apr 2022; AzTrials last refreshed its copy on 1 Nov 2026.