Electrical Vestibular Stimulation (VeNS) Compared to Sham Control as a Means of Reducing Excess Body Weight
Study Details
Study Description
Brief Summary
A randomized, double blind sham controlled clinical trial to evaluate the efficacy of vestibular nerve stimulation (VeNS), together with a lifestyle modification program, compared to a sham control with a lifestyle modification programme, as a means of reducing excess body weight and body fat.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Active Device Group 25 subjects randomised to receive active device use plus lifestyle intervention for 3 months. |
Device: Vestal Device
Vestibular nerve stimulator
Behavioral: Hypocaloric Diet
Hypocaloric diet
|
| Placebo Comparator: Control Device Group 25 subjects randomised to receive control device use plus lifestyle intervention for 3 months. |
Device: Control Device
Control Device
Behavioral: Hypocaloric Diet
Hypocaloric diet
|
Outcome Measures
Primary Outcome Measures
- Total body weight loss [12 weeks]
In kg
Eligibility Criteria
Criteria
Inclusion Criteria:
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- Body mass index (BMI) ≥ 25 kg/m2 2. Males or Females. Note females of child-bearing potential must have a negative urine pregnancy test 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).
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18-80 years of age inclusive on starting the study. 4. 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.
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Agreement not to use of prescription, or over-the-counter, weight loss preparations for the duration of the trial.
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Agreement not to start smoking tobacco or marijuana for the duration of the study.
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Access to Wi-Fi (to connect iPod to internet)
Exclusion Criteria:
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- History of vestibular dysfunction or other inner ear disease as indicated by the screening questions.
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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.
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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. 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) 8. Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent VeNS from working).
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Diagnosis of cirrhosis, chronic pancreatitis, or liver, kidney or heart failure.
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Treatment with prescription weight-loss drug therapy in the 6 months before starting the study.
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Tobacco or marijuana smoking in the 6 months before starting and for the duration of the study.
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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.
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Physician-prescribed diet, and/ or current, active member of an organized weight loss program.
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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.
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Regular use (more than twice a month) of anti-histamine medication within the last 6 months.
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Use of oral or intravenous corticosteroid medication within 6 months of starting the study.
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Use of the beta-blockers atenolol, metoprolol or propranolol within 3 months of starting the study.
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Current alterations in treatment regimens of anti-depressant medication for whatever reason (including tricyclic antidepressants) (Note: stable treatment regimen for prior 6 months acceptable).
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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).
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Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.).
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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.
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Pregnancy 30. History of migraine headaches
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Vincent's University Hospital | Dublin | Ireland | D04 T6F4 |
Sponsors and Collaborators
- Neurovalens Ltd.
- University College Dublin
- Exploristics Ltd
- Compliance Solutions Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 050719-UCD