Summary

for people ages 22-80 (full criteria)
healthy people welcome
at La Jolla, California and other locations
study started
estimated completion:
Erik Viirre

Description

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. 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).

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

Details

In total there will be approximately 123 patients enrolled on the study around both sites. At the UCSD site there will be a total of 78 total subjects (52 active treatment and 26 control subjects) who are randomized into the treatment protocols having passed the screening criteria. At the UU site there will be a total of 45 total subjects (30 active and 15 control subjects).

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 2:1 active to control allocation
  • The aim of the study is to recruit a total (i.e. across both sites) of 123 participants that pass the screening process and are randomized into the treatment protocols. With a dropout allowance of 15% this should generate a minimum of 70 active treatment and 35 control subjects. (In order to achieve adequate numbers, Neurovalens Ltd. estimate that the clinical site may have to consent (i.e. enroll into the study) up to 150 subjects at the UCSD site, in order to achieve adequate numbers, it is estimated that the clinical site may have to consent (i.e. enroll into the study) up to 90 subjects at the UU site, as the baseline screening can only take place after the formal consent process as the baseline screening can only take place after the formal consent process.) The designation of treatment across the two study sites will be as follows:
  • USCD: a total of 78 subjects who pass through screening and are randomized (52 active treatment and 26 control subjects);
  • University of Ulster: a total of 45 total subjects who pass through screening and are randomized (30 active and 15 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 both sites will be collated at the end of the studies and analysis will be performed on one data set.

Study staff will train the subject on how to use their study device. Specifically this will include: how to first prepare the skin over the mastoid processes with an alcohol wipe; a demonstration of where to place the hydrogel electrodes; how to access the VeSTAL study app and pair the iPod (using Bluetooth) to the device; how to operate the device using the app; and how to use the up/down buttons on the device if unable to use the study app. Study staff will provide subjects with a printed copy of the IFU and also highlight its location as a PDF on the iPod. The Device Use Schematic will also be highlighted to the subjects - it will only be as a PDF on the iPod.

Also study staff will demonstrate to the subjects: how to charge the device; to dispose of used electrodes after a stimulation session; how to store unused electrodes in a sealed manner so they do not dry out; how to turn the device on and off using the power button; and how to use the app or power button to pause a stimulation session.

Subjects will be asked to try and use their allocated device for an hour every day, and at least five times a week. Theoretically it is thought that the device may be more effective if used while sitting upright (as opposed to lying flat), due to the orientation of the otolith organs. As such subjects will be encouraged to use the device while sitting upright, and also in the evening as sometimes people can feel a bit soporific after vestibular stimulation. Subjects will be instructed not to walk around, operate machinery or drive while using their device.

Keywords

Obesity VeSTAL

Eligibility

You can join if…

Open to people ages 22-80

  1. Signed informed consent

Body mass index (BMI) ≥ 30 kg/m2, or BMI ≥ 27 kg/m2 with one or more of the below detailed obesity related co-morbid conditions:

  1. History of treatment for systemic hypertension
  2. History of treatment for dyslipidemia
  3. History of treatment for sleep apnea syndrome
  4. Stable cardiovascular disease (no change in medication and no active events within 1 year).
  5. 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).
  6. 22-80 years of age inclusive on starting the study. (In order to comply with FDA guidance:https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm08 9740.htm#s6)
  7. 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.
  8. Agreement not to use of prescription, or over-the-counter, weight loss preparations for the duration of the trial.
  9. Agreement not to start smoking tobacco or marijuana for the duration of the study.
  10. Access to Wi-Fi (to connect iPod to internet)

You CAN'T join if...

  1. History of vestibular dysfunction.
  2. History of bariatric surgery, or gastric resection.
  3. History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis)affecting the skin behind the ears.
  4. History of weight loss device implantation (e.g. VBloc Maestro or Abiliti).
  5. Use of a non-invasive weight loss device (e.g. Modius)
  6. Untreated thyroid disorder (stable treatment for 3 months is acceptable).
  7. Other endocrinological causes of weight gain (e.g. Cushing's disease, Cushing's syndrome or acromegaly)
  8. Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent VeNS from working).
  9. Diagnosis of cirrhosis, chronic pancreatitis, or liver, kidney or heart failure.
  10. . Treatment with prescription weight-loss drug therapy in the 6 months before starting the study.
  11. . Tobacco or marijuana smoking in the 6 months before starting and for the duration of the study.
  12. . Known genetic cause of obesity (e.g., Prader-Willi Syndrome).
  13. . Body weight change of more than 20% in either direction within the previous year.
  14. . Physician-prescribed diet, and/ or current, active member of an organized weight loss program.
  15. . Diabetes mellitus (Types 1 & 2).
  16. . Diagnosis of epilepsy or use of anti-epileptic medication within six months of starting the study (e.g. for the treatment of peripheral neuropathy)
  17. . Chronic (more than a month of daily use) treatment with opioid analgesic drugs within the last 6 months.
  18. . Regular use (more than twice a month) of anti-histamine medication within the last 6 months.
  19. . Use of oral or intravenous corticosteroid medication within 6 months of starting the study.
  20. . Use of the beta-blockers atenolol, metoprolol or propranolol within 3 months of starting the study.
  21. . Current alterations in treatment regimens of anti-depressant medication for whatever reason (including tricyclic antidepressants) (Note: stable treatment regimen for prior 6 months acceptable).
  22. . An active diagnosis of cancer.
  23. . A myocardial infarction within the preceding year.
  24. . 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).
  25. . Presence of permanently implanted battery powered medical device or stimulator (e.g.,pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.).
  26. . Psychiatric disorders (including untreated severe depression, schizophrenia, substance abuse, eating disorder etc.)
  27. . Current participant in another weight loss study or other clinical trial.
  28. . Have a family member who is currently participating or is planning to participate in this study.
  29. . Weight over 350 pounds as this is the weight limit of the DXA scanner.
  30. . Pregnancy

Locations

  • University of California San Diego not yet accepting patients
    La Jolla California 92093 United States
  • Univeristy of Ulster not yet accepting patients
    Coleraine United Kingdom

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Neurovalens Ltd.
ID
NCT03640286
Lead Scientist
Erik Viirre
Study Type
Interventional
Last Updated
September 3, 2018