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Vestibular Stimulation to Trigger Adipose Loss (VeSTAL) Clinical Trial

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ClinicalTrials.gov Identifier: NCT03640286
Recruitment Status : Not yet recruiting
First Posted : August 21, 2018
Last Update Posted : April 18, 2019
Sponsor:
Collaborators:
University of California, San Diego
University of Ulster
Exploristics
Information provided by (Responsible Party):
Neurovalens Ltd.

Tracking Information
First Submitted Date  ICMJE August 13, 2018
First Posted Date  ICMJE August 21, 2018
Last Update Posted Date April 18, 2019
Estimated Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2019)
  • Mean total body weight loss [ Time Frame: 12 months ]
    There should be at least a 2% total body weight loss (TBWL) superiority margin between the active-product and sham-treated groups.
  • Categorical: proportion of participants who lose 5% total body weight [ Time Frame: 12 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
Original Primary Outcome Measures  ICMJE
 (submitted: August 17, 2018)
  • Difference in Mean Weight Loss [ Time Frame: 6 months ]
    Mean: The difference in mean weight loss between the active-product and placebo-treated groups is at least 5% total body weight lost, and the difference is statistically significant
  • Proportion of participants who lose at least 5% body weight [ Time Frame: 6 months ]
    Categorical: The proportion of participants who lose 5% or more of baseline body weight in the active-product group is at least 35% and is approximately double the proportion in the placebo-treated group; the difference between groups is statistically significant
  • Mean Fat Loss [ Time Frame: 6 months ]
    The mean fat loss is greater in the active-product group than in the placebo-treated group, and the difference is statistically significant. (As measured by means of a whole body DXA scan).
Change History Complete list of historical versions of study NCT03640286 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2019)
  • Mean Fat Loss [ Time Frame: 12 months ]
    The mean fat loss (in grams) is greater in the active-product group than in the placebo-treated group, and the difference is statistically significant. (As measured by means of a whole body DXA scan).
  • Mean percent loss of baseline truncal body fat [ Time Frame: 12 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).
  • Mean percent loss of baseline visceral adipose tissue [ Time Frame: 12 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).
  • Difference in lean muscle mass in the active versus placebo treated group [ Time Frame: 12 months ]
    Difference in lean muscle mass (in grams) in the active versus placebo treated group. (As measured by the whole body DXA scan).
  • Difference in bone mineral content [ Time Frame: 12 months ]
    Difference in bone mineral content (in grams) in the active versus placebo treated group. (As measured by the whole body DXA scan).
  • Fasting glucose [ Time Frame: 12 months ]
    Fasting glucose in mg/dL
  • Glycated hemoglobin [ Time Frame: 12 months ]
    HbA1c as a percentage
  • Lipid profile [ Time Frame: 12 months ]
    Lipid profile (Assess total non-HDL cholesterol, and HDL to total cholesterol ratio) in mg/dl
  • High sensitivity CRP [ Time Frame: 12 months ]
    High sensitivity CRP in mg/L
  • Quality of Life ratings [ Time Frame: 12 months ]
    As assessed using IWQoL scale
  • Blood pressure [ Time Frame: 12 months ]
    Blood pressure in mmHg
  • Heart rate [ Time Frame: 12 months ]
    Heart rate in beats per minute
  • Hip-waist ratio [ Time Frame: 12 months ]
    Hip-waist ratio
  • Body Mass Index (BMI) in [ Time Frame: 12 months ]
    BMI in kg/m^2
Original Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2018)
  • Mean percent loss of baseline truncal body fat [ Time Frame: 12 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).
  • Mean percent loss of baseline visceral adipose tissue [ Time Frame: 12 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).
  • Difference in lean muscle mass in the active versus placebo treated group [ Time Frame: 12 months ]
    Difference in lean muscle mass in the active versus placebo treated group. (As also automatically measured by the whole body DXA scan).
  • Difference in bone mineral content [ Time Frame: 12 months ]
    Difference in bone mineral content in the active versus placebo treated group. (As also automatically measured by the whole body DXA scan).
  • Fasting glucose [ Time Frame: 12 months ]
    Fasting glucose
  • Lipid profile [ Time Frame: 12 months ]
    Lipid profile (Assess total non-HDL cholesterol, and HDL to total cholesterol ratio)
Current Other Pre-specified Outcome Measures
 (submitted: February 27, 2019)
  • Dose Response Analysis [ Time Frame: 12 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.
  • Change in concomitant medication [ Time Frame: 12 months ]
    Adjustment of medication - both reduction and new medications.
  • Adverse Event Monitoring Questionnaire [ Time Frame: 6 & 12 months ]
    All subjects will complete an adverse event monitoring questionnaire
  • Hearing test [ Time Frame: 6 & 12 months ]
    Hearing test to assess change using NCI: CTCAE grading.
  • Health of ear canal and tympanic membrane [ Time Frame: 6 & 12 months ]
    Health of ear canal and tympanic membrane (Judged to be healthy, unhealthy or occluded by examining clinician).
  • Total Energy intake (kJ) [ Time Frame: 6 & 12 months ]
    Total Energy intake (kJ) as assessed by 24 hour dietary recall and Food Frequency Questionnaire
  • Protein [ Time Frame: 6 & 12 months ]
    Protein (grams) as assessed by 24 hour dietary recall and Food Frequency Questionnaire
  • Fat & saturated fat [ Time Frame: 6 & 12 months ]
    Fat & saturated fat (grams) as assessed by 24 hour dietary recall and Food Frequency Questionnaire
  • Carbohydrate; starchy carbohydrates, sugars, and free sugars [ Time Frame: 6 & 12 months ]
    Carbohydrate; starchy carbohydrates, sugars, and free sugars (grams) as assessed by 24 hour dietary recall and Food Frequency Questionnaire
  • Fiber [ Time Frame: 6 & 12 months ]
    Fiber (grams) as assessed by 24 hour dietary recall and Food Frequency Questionnaire
  • Alcohol [ Time Frame: 6 & 12 months ]
    Alcohol (grams) as assessed by 24 hour dietary recall and Food Frequency Questionnaire
  • Healthy Eating Index Score [ Time Frame: 6 & 12 months ]
    HEI-2015 score (out of 100) as assessed by 24 hour dietary recall and Food Frequency Questionnaire
  • Total Physical Activity averaged over the past year in hours per week [ Time Frame: 6 & 12 months ]
    Total Physical Activity averaged over the past year in hours per week as assessed by the Modifiable Activity Questionnaire
  • Total Physical Activity averaged over the past year in hours per week [ Time Frame: 6 & 12 months ]
    Total Physical Activity averaged over the past year in MET-hours per week as assessed by the Modifiable Activity Questionnaire
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vestibular Stimulation to Trigger Adipose Loss (VeSTAL) Clinical Trial
Official Title  ICMJE 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
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).

Detailed Description

In total there will be approximately 123 patients enrolled on the study around both sites. At the UCSD site there will be a total of 78 total subjects (52 active treatment and 26 control subjects) who are randomized into the treatment protocols having passed the screening criteria. At the UU site there will be a total of 45 total subjects (30 active and 15 control subjects).

The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS), together with a lifestyle modification program, as a method of reducing excess body weight and body fat, as compared to a sham control with both study arms incorporating a lifestyle modification program.

  • Allocation: Randomized
  • Endpoint classification: Efficacy Study
  • Intervention Model: Parallel Assignment in 2:1 active to control allocation
  • The aim of the study is to recruit a total (i.e. across both sites) of 123 participants that pass the screening process and are randomized into the treatment protocols. With a dropout allowance of 15% this should generate a minimum of 70 active treatment and 35 control subjects. (In order to achieve adequate numbers, Neurovalens Ltd. estimate that the clinical site may have to consent (i.e. enroll into the study) up to 150 subjects at the UCSD site, in order to achieve adequate numbers, it is estimated that the clinical site may have to consent (i.e. enroll into the study) up to 90 subjects at the UU site, as the baseline screening can only take place after the formal consent process as the baseline screening can only take place after the formal consent process.) The designation of treatment across the two study sites will be as follows:

    • USCD: a total of 78 subjects who pass through screening and are randomized (52 active treatment and 26 control subjects);
    • University of Ulster: a total of 45 total subjects who pass through screening and are randomized (30 active and 15 control subjects).
  • Masking: Double Blind (Subject, Nursing staff, Dietician, Co-coordinators, Outcomes Assessor and any other study staff who have contact with the subject)
  • Data from both sites will be collated at the end of the studies and analysis will be performed on one data set.

Study staff will train the subject on how to use their study device. Specifically this will include: how to first prepare the skin over the mastoid processes with an alcohol wipe; a demonstration of where to place the hydrogel electrodes; how to access the VeSTAL study app and pair the iPod (using Bluetooth) to the device; how to operate the device using the app; and how to use the up/down buttons on the device if unable to use the study app. Study staff will provide subjects with a printed copy of the IFU and also highlight its location as a PDF on the iPod. The Device Use Schematic will also be highlighted to the subjects - it will only be as a PDF on the iPod.

Also study staff will demonstrate to the subjects: how to charge the device; to dispose of used electrodes after a stimulation session; how to store unused electrodes in a sealed manner so they do not dry out; how to turn the device on and off using the power button; and how to use the app or power button to pause a stimulation session.

Subjects will be asked to try and use their allocated device for an hour every day, and at least five times a week. Theoretically it is thought that the device may be more effective if used while sitting upright (as opposed to lying flat), due to the orientation of the otolith organs. As such subjects will be encouraged to use the device while sitting upright, and also in the evening as sometimes people can feel a bit soporific after vestibular stimulation. Subjects will be instructed not to walk around, operate machinery or drive while using their device.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double blind
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: VeSTAL
  • 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.
    Intervention: Device: VeSTAL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 17, 2018)
123
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2020
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Sponsor's Regulatory Consultant +447760556975 tara.brownlow@neurovalens.com
Contact: Catherine Maingot, PhD catherine@cslifesciences.com
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03640286
Other Study ID Numbers  ICMJE 243973
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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.
Responsible Party Neurovalens Ltd.
Study Sponsor  ICMJE Neurovalens Ltd.
Collaborators  ICMJE
  • University of California, San Diego
  • University of Ulster
  • Exploristics
Investigators  ICMJE
Principal Investigator: Erik Viirre, MD PhD UC San Diego
PRS Account Neurovalens Ltd.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP