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Electrical Vestibular Nerve Stimulation (VeNS) Compared to Sham Control as a Means of Reducing Excess Body Weight

Primary Purpose

Overweight, Obesity, Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Vestal Device
Control Device
Hypocaloric Diet
Sponsored by
Neurovalens Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 1. 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).

    3. 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.

    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 or other inner ear disease as indicated by the screening questions.

    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. Pregnancy 30. History of migraine headaches

Sites / Locations

  • St. Vincent's University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Device Group

Control Device Group

Arm Description

25 subjects randomised to receive active device use plus lifestyle intervention for 3 months.

25 subjects randomised to receive control device use plus lifestyle intervention for 3 months.

Outcomes

Primary Outcome Measures

Total body weight loss
In kg

Secondary Outcome Measures

Full Information

First Posted
September 29, 2019
Last Updated
March 29, 2023
Sponsor
Neurovalens Ltd.
Collaborators
University College Dublin, Exploristics Ltd, Compliance Solutions Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04110717
Brief Title
Electrical Vestibular Nerve Stimulation (VeNS) Compared to Sham Control as a Means of Reducing Excess Body Weight
Official Title
Electrical Vestibular Nerve Stimulation (VeNS) Together With a Lifestyle Modification Program, Compared to a Sham Control With a Lifestyle Modification Program, as a Means of Reducing Excess Body Weight and Body Fat.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 9, 2020 (Actual)
Primary Completion Date
March 23, 2021 (Actual)
Study Completion Date
March 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurovalens Ltd.
Collaborators
University College Dublin, Exploristics Ltd, Compliance Solutions Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Overweight and Obesity, Overweight or Obesity, Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Device Group
Arm Type
Experimental
Arm Description
25 subjects randomised to receive active device use plus lifestyle intervention for 3 months.
Arm Title
Control Device Group
Arm Type
Placebo Comparator
Arm Description
25 subjects randomised to receive control device use plus lifestyle intervention for 3 months.
Intervention Type
Device
Intervention Name(s)
Vestal Device
Intervention Description
Vestibular nerve stimulator
Intervention Type
Device
Intervention Name(s)
Control Device
Intervention Description
Control Device
Intervention Type
Behavioral
Intervention Name(s)
Hypocaloric Diet
Intervention Description
Hypocaloric diet
Primary Outcome Measure Information:
Title
Total body weight loss
Description
In kg
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. 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). 3. 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. 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 or other inner ear disease as indicated by the screening questions. 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. Pregnancy 30. History of migraine headaches
Facility Information:
Facility Name
St. Vincent's University Hospital
City
Dublin
ZIP/Postal Code
D04 T6F4
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Electrical Vestibular Nerve Stimulation (VeNS) Compared to Sham Control as a Means of Reducing Excess Body Weight

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