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Vestibular Stimulation to Trigger Adipose Loss (VeSTAL) Clinical Trial (VeSTAL)

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ClinicalTrials.gov Identifier: NCT03640286
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : October 1, 2019
Sponsor:
Collaborators:
University of California, San Diego
University of Ulster
Exploristics
Information provided by (Responsible Party):
Neurovalens Ltd.

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).


Condition or disease Intervention/treatment Phase
Obesity Device: VeSTAL Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blind
Primary Purpose: Treatment
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
Actual Study Start Date : August 23, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: VeSTAL - active device
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
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 Comparator: Sham device
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
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.




Primary Outcome Measures :
  1. Mean total body weight loss [ Time Frame: 6 months ]
    There should be at least a 2% total body weight loss (TBWL) superiority margin between the active-product and sham-treated groups.

  2. Categorical: proportion of participants who lose 5% total body weight [ Time Frame: 6 months ]
    The proportion of participants who lose 5% TBWL or more in the active-product group is at least 50%, independent of the sham control


Secondary Outcome Measures :
  1. Total Energy intake (kJ) [ Time Frame: 6 months ]
    Total Energy intake (kJ) as assessed by two-day 24 hour dietary recall.

  2. Atherogenic Index [ Time Frame: 6 months ]
    Using lipid profile to calculate ratio of Total Cholesterol: HDL

  3. Percentage Fat Loss [ Time Frame: 6 months ]
    Percentage fat loss from baseline. (As measured by means of a whole body DXA scan).

  4. High sensitivity CRP [ Time Frame: 6 months ]
    High sensitivity CRP in mg/L

  5. Quality of Life ratings [ Time Frame: 6 months ]
    As assessed using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire, which is a validated self-report measure of obesity-specific quality of life in adults. The score ranges from 0 to 100, with 100 indicating the best quality of life.

  6. Mean percent loss of baseline truncal body fat [ Time Frame: 6 months ]
    The difference in mean percent loss of baseline truncal body fat in the active versus placebo treated groups. (As measured by a whole body DXA scan).

  7. Mean percent loss of baseline visceral adipose tissue [ Time Frame: 6 months ]
    The difference in mean percent loss of baseline visceral adipose tissue in the active versus placebo treated groups. (As measured by a whole body DXA scan).

  8. Difference in lean muscle mass in the active versus placebo treated group [ Time Frame: 6 months ]
    Difference in lean muscle mass (in grams) in the active versus placebo treated group. (As measured by the whole body DXA scan).

  9. Difference in bone mineral content [ Time Frame: 6 months ]
    Difference in bone mineral content (in grams) in the active versus placebo treated group. (As measured by the whole body DXA scan).

  10. Fasting glucose [ Time Frame: 6 months ]
    Fasting glucose in mg/dL

  11. Glycated hemoglobin [ Time Frame: 6 months ]
    HbA1c as a percentage

  12. Lipid profile [ Time Frame: 6 months ]
    Lipid profile

  13. Blood pressure [ Time Frame: 6 months ]
    Blood pressure in mmHg

  14. Heart rate [ Time Frame: 6 months ]
    Heart rate in beats per minute

  15. Hip-waist ratio [ Time Frame: 6 months ]
    Hip-waist ratio

  16. Body Mass Index (BMI) in [ Time Frame: 6 months ]
    BMI in kg/m^2

  17. Durability of weight loss [ Time Frame: 12 months ]
    Maintenance of weight from 6 month timepoint (in kg)


Other Outcome Measures:
  1. Dose Response Analysis [ Time Frame: 6 months ]
    It is likely that some subjects will use their device more than other. Usage data will be available from the devices permitting a dose response analysis, which will done be in an intention to treat manner.

  2. Change in concomitant medication [ Time Frame: 6 months ]
    Adjustment of medication - both reduction and new medications for cardiovascular disease and type 2 diabetes mellitus.

  3. Adverse Event Monitoring Questionnaire [ Time Frame: 6 months ]
    All subjects will complete an adverse event monitoring questionnaire

  4. Adverse Event Monitoring Questionnaire [ Time Frame: 12 months ]
    All subjects will complete an adverse event monitoring questionnaire which details the common side effects of vestibular stimulation. There is no scale, rather qualitative summary statistics will be provided.

  5. Hearing test [ Time Frame: 6 months ]
    Hearing test to assess change using NCI: CTCAE grading.

  6. Hearing test [ Time Frame: 12 months ]
    Hearing test to assess change using NCI: CTCAE grading.

  7. Health of ear canal and tympanic membrane [ Time Frame: 6 months ]
    Health of ear canal and tympanic membrane (Judged to be healthy, unhealthy or occluded by examining clinician).

  8. Health of ear canal and tympanic membrane [ Time Frame: 12 months ]
    Health of ear canal and tympanic membrane (Judged to be healthy, unhealthy or occluded by examining clinician).

  9. Protein [ Time Frame: 6 months ]
    Protein (grams) as assessed by 24 hour dietary recall and Food Frequency Questionnaire

  10. Protein [ Time Frame: 12 months ]
    Protein (grams) as assessed by 24 hour dietary recall and Food Frequency Questionnaire

  11. Fat & saturated fat [ Time Frame: 6 months ]
    Fat & saturated fat (grams) as assessed by 24 hour dietary recall and Food Frequency Questionnaire

  12. Fat & saturated fat [ Time Frame: 12 months ]
    Fat & saturated fat (grams) as assessed by 24 hour dietary recall and Food Frequency Questionnaire

  13. Carbohydrate; starchy carbohydrates, sugars, and free sugars [ Time Frame: 6 months ]
    Carbohydrate; starchy carbohydrates, sugars, and free sugars (grams) as assessed by 24 hour dietary recall and Food Frequency Questionnaire

  14. Carbohydrate; starchy carbohydrates, sugars, and free sugars [ Time Frame: 12 months ]
    Carbohydrate; starchy carbohydrates, sugars, and free sugars (grams) as assessed by 24 hour dietary recall and Food Frequency Questionnaire

  15. Fiber [ Time Frame: 6 months ]
    Fiber (grams) as assessed by 24 hour dietary recall and Food Frequency Questionnaire

  16. Fiber [ Time Frame: 12 months ]
    Fiber (grams) as assessed by 24 hour dietary recall and Food Frequency Questionnaire

  17. Alcohol [ Time Frame: 6 months ]
    Alcohol (grams) as assessed by 24 hour dietary recall and Food Frequency Questionnaire

  18. Alcohol [ Time Frame: 12 months ]
    Alcohol (grams) as assessed by 24 hour dietary recall and Food Frequency Questionnaire

  19. Healthy Eating Index [ Time Frame: 6 months ]
    Nutrient intakes assessment from two-day 24-hour recall. Score out of 100 with a higher score reflecting a better quality of diet.

  20. Healthy Eating Index [ Time Frame: 12 months ]
    Nutrient intakes assessment from two-day 24-hour recall. Score out of 100 with a higher score reflecting a better quality of diet.

  21. Total Physical Activity in hours per week [ Time Frame: 6 months ]
    Total Physical Activity averaged over the past year in hours per week as assessed by the Modifiable Activity Questionnaire

  22. Total Physical Activity in hours per week [ Time Frame: 12 months ]
    Total Physical Activity averaged over the past year in hours per week as assessed by the Modifiable Activity Questionnaire

  23. Total Physical Activity in MET-hours per week [ Time Frame: 6 months ]
    Total Physical Activity averaged over the past year in MET-hours per week as assessed by the Modifiable Activity Questionnaire

  24. Total Physical Activity in MET-hours per week [ Time Frame: 12 months ]
    Total Physical Activity averaged over the past year in MET-hours per week as assessed by the Modifiable Activity Questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  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).
  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. (In order to comply with FDA guidance: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089740.htm#s6)
  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.
  5. Agreement not to use of prescription, or over-the-counter, weight loss preparations for the duration of the trial.
  6. Agreement not to start smoking tobacco or marijuana for the duration of the study.
  7. Access to Wi-Fi (to connect iPod to internet)

Exclusion Criteria:

  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. 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).
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03640286


Contacts
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Contact: Sponsor's Regulatory Consultant +447760556975 tara.brownlow@neurovalens.com
Contact: Catherine Maingot, PhD catherine@cslifesciences.com

Locations
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United States, California
University of California San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Jeff Ledford-Mills, BA    619-786-2854    jhmills@ucsd.edu   
Contact: Baharin Abdullah, MD       baabdullah@ucsd.edu   
Principal Investigator: Erik Viirre, MD PhD         
Sub-Investigator: Jeff Ledord-Mills, BA         
Sub-Investigator: Baharin Abdullah, MD         
Sub-Investigator: Donna Brusch, MA         
Sub-Investigator: Archana Bhatt         
Sub-Investigator: Cynthia Knott, RDN         
United Kingdom
Univeristy of Ulster Recruiting
Coleraine, United Kingdom
Contact: Julie Sittlington, PhD       jj.sittlington@ulster.ac.uk   
Contact: Ruth Price, PhD       rk.price@ulster.ac.uk   
Sub-Investigator: Ruth Price, PhD         
Principal Investigator: Julie Sittlington, PhD         
Sponsors and Collaborators
Neurovalens Ltd.
University of California, San Diego
University of Ulster
Exploristics
Investigators
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Principal Investigator: Erik Viirre, MD PhD UC San Diego

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Responsible Party: Neurovalens Ltd.
ClinicalTrials.gov Identifier: NCT03640286     History of Changes
Other Study ID Numbers: 243973
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be transferred in an encrypted PDF format. Trial staff will be given direction on how to share the trial data and given access to one specific section of a controlled cloud service which is controlled via role based access. Once they have authenticated with the service and the service verifies that they have the correct role to access the system they will be directed to a single webpage within the application where they will be able to upload the encrypted PDF. This PDF is generated on the fly and is therefore not stored in another location that could become compromised. Generating the PDF on the fly means that the source data is extracted from the database, processed and delivered in the context of a single request. These data will be transferred for each subject when they complete participation in the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Neurovalens Ltd.:
Overweight
Metabolic syndrome
Weight loss
Diet
Atherogenic index