Vestibular Stimulation to Trigger Adipose Loss Clinical Trial (VeSTAL)

This is an interventional treatment trial for Obesity focused on measuring Obesity, Metabolic Syndrome, Prediabetes, Glycemic control, Hypercholesterolemia, Abdominal obesity, Weight Loss Read More

Inclusion Criteria:

1. 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:

   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).
2. 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).
3. 22-80 years of age inclusive on starting the study.
4. Ability and willingness to complete all study visits and procedures.
5. 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.
6. Agreement not to use of prescription drug therapy or the use of over-the-counter weight loss preparations for the duration of the trial.
7. Agreement not to start smoking tobacco or marijuana for the duration of the study.

Exclusion Criteria:

1. History of vestibular dysfunction.
2. History of bariatric surgery, fundoplication, gastric resection or major upper-abdominal surgery (acceptable surgeries include cholecystectomy, hysterectomy).
3. History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears, or of the head and neck.
4. History of weight loss device implantation (e.g. VBloc Maestro or Abiliti), or use of a non-invasive device.
5. Untreated thyroid disorder (stable treatment for 3 months is acceptable).
6. Other endocrinological causes of weight gain (e.g. Cushing's disease, Cushing's syndrome or acromegaly)
7. Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent VeNS from working).
8. History of cirrhosis, or liver, kidney or heart failure.
9. Chronic pancreatitis.
10. Treatment with prescription weight-loss drug therapy in the year before starting the study.
11. Tobacco or marijuana smoking in the year prior to 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 10% in either direction within the previous year.
14. 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)
15. Diabetes mellitus (Types 1 & 2). (See Section 9 Research Design and Methods, Appendix 3)
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 year.
18. Regular use (more than twice a month) of anti-histamine medication.
19. Use of oral or intravenous corticosteroid medication within a year 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 (other than tricyclic antidepressants) (Note: stable treatment regimen for prior six 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 intensive care). (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, bulimia nervosa etc.)
27. Current participant in another weight loss study or other clinical trials.
28. Have a family member who is currently participating or is planning to participate in this study.
29. Subject weighs over 350 pounds as this is the weight limit of the DXA scanner.