Vestibular Stimulation to Trigger Adipose Loss (VeSTAL) Clinical Trial

NCT03640286 | Completed Results FDA Device

• 1 other identifier: 243973
• Study Type: interventional
• Target: 241
• Locations: 2 countries
• Sites: 4

Brief 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).

Conditions

Obesity

Keywords

Overweight; Metabolic syndrome; Weight loss; Diet; Atherogenic index; Prediabetes

Outcome Measures

Primary Outcomes (2)

• Percentage Change of Weight From Baseline

  The mean percentage weight loss achieved by the Vestal active device in comparison to the sham device

  From baseline to 6 months

• Categorical: Proportion of Participants Who Lose 5% Total Body Weight

  The proportion of participants who lose 5% total body weight or more in the active Vestal group is at least 50%, independent of the sham control

  6 months

Secondary Outcomes (7)

• Mean Percent Loss of Baseline Visceral Adipose Tissue

  % change in VAT mass at 6 months

• Percentage Fat Loss

  Percentage change from baseline to 6 months

• Difference in Lean Muscle Mass in the Active Versus Placebo Treated Group

  Absolute change at 3 months and 6 months

• Atherogenic Index

  Absolute change from baseline to 6 months

• Systemic Inflammation

  Percentage change from baseline to 6 months

Other Outcomes (21)

• Baseline Truncal Body Fat

  Baseline

• 6 Month Truncal Body Fat

  6 Month

• Difference in Bone Mineral Content

  Absolute change from baseline to 6 months

Study Arms (2)

VeSTAL - active device

ACTIVE COMPARATOR

The VeSTAL device utilizes a technology called galvanic vestibular stimulation (GVS) (sometimes termed vestibular nerve stimulation (VeNS)). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day.

Device: VeSTAL

Sham device

SHAM COMPARATOR

The sham device looks identical to the active device and interacts with the app in a similar manner to the active device. However, it does not deliver vestibular stimulation to users. The device will be placed on the head in a manner analogous to headphones with hydrogel electrodes placed over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day.

Device: VeSTAL

Interventions

VeSTAL DEVICE

The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation in combination with a lifestyle modification program, as a method of reducing excess body weight and body fat, as compared to a sham device in combination with the same lifestyle modification program.

Sham device; VeSTAL - active device

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Body mass index BMI ≥ 27 kg/m2.
• 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. (In order to comply with FDA guidance: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089740.htm#s6)
• 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.
• Agreement not to use of prescription, or over-the-counter, weight loss preparations for the duration of the trial.
• Agreement not to start smoking tobacco or marijuana

You may not qualify if:

• History of vestibular dysfunction or other inner ear disease as indicated by the screening questions.
• History of bariatric surgery, or gastric resection.
• History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
• History of weight loss device implantation (e.g. VBloc Maestro or Abiliti).
• Use of a non-invasive weight loss device (e.g. Modius)
• 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).
• 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).
• Diagnosis of cirrhosis, chronic pancreatitis, or liver, kidney or heart failure.
• Treatment with prescription weight-loss drug therapy in the 6 months before starting the study.
• Tobacco smoking (including vaping) in the six months prior to starting and for the duration of the study.
• Use of marijuana (smoking, vaping or in edible form) more than twice a month on average.
• Known genetic cause of obesity (e.g., Prader-Willi Syndrome).
• Body weight change of more than 20% in either direction within the previous year.
• Physician-prescribed diet, and/ or current, active member of an organized weight loss program.

Sponsors & Collaborators

• Neurovalens Ltd.: lead
• University of California, San Diego: collaborator
• University of Ulster: collaborator
• Exploristics: collaborator
• Compliance Solutions Ltd.: collaborator

Study Sites (4)

UC San Diego, Exercise and Physical Activity Resource Center

La Jolla, California, 92093, United States

Location

University of California San Diego, Altman Clinical & Translational Research Institute,

La Jolla, California, 92093, United States

Location

Texas Diabetes and Endocrinology

Austin, Texas, 78749, United States

Location

Univeristy of Ulster

Coleraine, United Kingdom

Location

MeSH Terms

Conditions

Obesity; Overweight; Metabolic Syndrome; Weight Loss; Prediabetic State

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Head of Clinical and Regulatory
• Organization: Neurovalens

sinead.watson@neurovalens.com

02890991835

Study Officials

• Erik Viirre, MD PhD

  UC San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 21, 2018
• Study Start: August 23, 2019
• Primary Completion: April 26, 2022
• Study Completion: April 26, 2022
• Last Updated: March 12, 2025
• Results First Posted: March 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); US (3)