Vestibular Stimulation to Trigger Adipose Loss Clinical Trial

NCT03138369 | Terminated Results

• 1 other identifier: 170255
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Obesity; Obesity, Abdominal; Metabolic Syndrome; Weight Loss

Keywords

Obesity; Metabolic Syndrome; Prediabetes; Glycemic control; Hypercholesterolemia; Abdominal obesity; Weight Loss

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Baseline and 12 months

Secondary Outcomes (4)

• Visceral Adipose Tissue

  Baseline and 12 months

• Lean Muscle

  Baseline and 12 months

• Change in Categorical Body Fat

  Baseline and 12 months

• Change in Mean Body Fat (g)

  12 months

Study Arms (2)

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.

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.

Device: Sham vestibular stimulation

Interventions

Vestibular nerve stimulator DEVICE

Battery powered headset that can be recharged when not being used.

Also known as: Galvanic vestibular stimulation

Vestibular nerve stimulation

Sham vestibular stimulation DEVICE

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.

Sham vestibular nerve stimulation

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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).
• 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.

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Neurovalens Ltd.: lead
• University of California, San Diego: collaborator

Study Sites (1)

Altman Clinical and Translation Research Institute, UC San Diego

San Diego, California, 92037, United States

Location

Related Links

• Pilot Study on Biorxiv

MeSH Terms

Conditions

Obesity; Obesity, Abdominal; Metabolic Syndrome; Weight Loss; Prediabetic State; Hypercholesterolemia

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Body Weight Changes; Diabetes Mellitus; Endocrine System Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Results Point of Contact

• Title: Paul McGeoch, MD
• Organization: Neurovalens Ltd

paul.mcgeoch@neurovalens.com

858-232-3312

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment in 1:1 active to control allocation

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: May 3, 2017
• Study Start: November 6, 2017
• Primary Completion: December 14, 2018
• Study Completion: December 14, 2018
• Last Updated: April 27, 2022
• Results First Posted: April 27, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)