Trial Outcomes & Findings for Vestibular Stimulation to Trigger Adipose Loss Clinical Trial (NCT NCT03138369)

NCT ID: NCT03138369

Last Updated: 2022-04-27

Results Overview

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

• Recruitment status: TERMINATED
• Target enrollment: 22 participants
• Primary outcome timeframe: Baseline and 12 months
• Results posted on: 2022-04-27

Participant Flow

Participant milestones

Measure	Vestibular Nerve Stimulation 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. Vestibular nerve stimulator: Battery powered headset that can be recharged when not being used.	Sham Vestibular Nerve Stimulation 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. Sham vestibular stimulation: Identical in external appearance to the vestibular nerve stimulation device, this device is also powered by a battery and needs to be periodically recharged when not being used. However, it discharges into an internal resistor and does not stimulate the vestibular nerve.
Overall Study STARTED	11	11
Overall Study COMPLETED	8	3
Overall Study NOT COMPLETED	3	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vestibular Stimulation to Trigger Adipose Loss Clinical Trial

Baseline characteristics by cohort

Measure	Vestibular Nerve Stimulation n=11 Participants 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. Vestibular nerve stimulator: Battery powered headset that can be recharged when not being used.	Sham Vestibular Nerve Stimulation n=11 Participants 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. Sham vestibular stimulation: Identical in external appearance to the vestibular nerve stimulation device, this device is also powered by a battery and needs to be periodically recharged when not being used. However, it discharges into an internal resistor and does not stimulate the vestibular nerve.	Total n=22 Participants Total of all reporting groups
Age, Continuous	51.4 years STANDARD_DEVIATION 12.1 • n=5 Participants	59.8 years STANDARD_DEVIATION 9.93 • n=7 Participants	55.6 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 months

Population: Please note this trial was terminated early

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

Outcome measures

Measure	Vestibular Nerve Stimulation n=8 Participants 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. Vestibular nerve stimulator: Battery powered headset that can be recharged when not being used.	Sham Vestibular Nerve Stimulation n=3 Participants 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. Sham vestibular stimulation: Identical in external appearance to the vestibular nerve stimulation device, this device is also powered by a battery and needs to be periodically recharged when not being used. However, it discharges into an internal resistor and does not stimulate the vestibular nerve.
Change in Mean Body Weight (kg)	-1 Kilograms (kg) Standard Deviation 6.90	2.47 Kilograms (kg) Standard Deviation 4.55

PRIMARY outcome

Timeframe: Baseline and 12 months

Population: Please note this trial was terminated early.

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

Outcome measures

Measure	Vestibular Nerve Stimulation n=8 Participants 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. Vestibular nerve stimulator: Battery powered headset that can be recharged when not being used.	Sham Vestibular Nerve Stimulation n=3 Participants 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. Sham vestibular stimulation: Identical in external appearance to the vestibular nerve stimulation device, this device is also powered by a battery and needs to be periodically recharged when not being used. However, it discharges into an internal resistor and does not stimulate the vestibular nerve.
Change in Categorical Body Weight	-0.40 kg/m^2 Standard Deviation 2.50	1.00 kg/m^2 Standard Deviation 1.83

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Please note this trial was terminated early.

The difference in mean percent loss of baseline visceral adipose tissue (in kilograms) in the vestibular stimulation versus sham stimulation group, as measured by means of a whole body DXA scan. Change = 12 month score - baseline score

Outcome measures

Measure	Vestibular Nerve Stimulation n=8 Participants 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. Vestibular nerve stimulator: Battery powered headset that can be recharged when not being used.	Sham Vestibular Nerve Stimulation n=3 Participants 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. Sham vestibular stimulation: Identical in external appearance to the vestibular nerve stimulation device, this device is also powered by a battery and needs to be periodically recharged when not being used. However, it discharges into an internal resistor and does not stimulate the vestibular nerve.
Visceral Adipose Tissue	-35.9 Grams (g) Standard Deviation 106.1	172.7 Grams (g) Standard Deviation 372.5

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Data was not collected

Change in total lean (muscle) mass in kilograms between vestibular stimulation and sham stimulation groups as assessed using whole body DXA scans.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Data was not collected.

The proportion of subjects who lose at least 5% of baseline total body fat in the active versus placebo treated groups. (As measured by a whole body DXA scan).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

The difference in mean percent loss of baseline total body fat in the active versus placebo treated groups. (As measured by means of a whole body DXA scan). Change = 12 month score - baseline score

Outcome measures

Measure	Vestibular Nerve Stimulation n=8 Participants 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. Vestibular nerve stimulator: Battery powered headset that can be recharged when not being used.	Sham Vestibular Nerve Stimulation n=3 Participants 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. Sham vestibular stimulation: Identical in external appearance to the vestibular nerve stimulation device, this device is also powered by a battery and needs to be periodically recharged when not being used. However, it discharges into an internal resistor and does not stimulate the vestibular nerve.
Change in Mean Body Fat (g)	152.74 Grams (g) Standard Deviation 4912.74	3769.37 Grams (g) Standard Deviation 4651.19

Adverse Events

Vestibular Nerve Stimulation

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Sham Vestibular Nerve Stimulation

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Vestibular Nerve Stimulation n=11 participants at risk 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. Vestibular nerve stimulator: Battery powered headset that can be recharged when not being used.	Sham Vestibular Nerve Stimulation n=11 participants at risk 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. Sham vestibular stimulation: Identical in external appearance to the vestibular nerve stimulation device, this device is also powered by a battery and needs to be periodically recharged when not being used. However, it discharges into an internal resistor and does not stimulate the vestibular nerve.
Immune system disorders Multi-resistant bacterial infection - Non-device related SAE	9.1% 1/11 • Number of events 1 • 12 months Low-risk device - Adverse events and serious adverse events were collected throughout the trial and followed-up with, including after trial termination.	0.00% 0/11 • 12 months Low-risk device - Adverse events and serious adverse events were collected throughout the trial and followed-up with, including after trial termination.

Other adverse events

Measure	Vestibular Nerve Stimulation n=11 participants at risk 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. Vestibular nerve stimulator: Battery powered headset that can be recharged when not being used.	Sham Vestibular Nerve Stimulation n=11 participants at risk 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. Sham vestibular stimulation: Identical in external appearance to the vestibular nerve stimulation device, this device is also powered by a battery and needs to be periodically recharged when not being used. However, it discharges into an internal resistor and does not stimulate the vestibular nerve.
Nervous system disorders Headache	36.4% 4/11 • Number of events 4 • 12 months Low-risk device - Adverse events and serious adverse events were collected throughout the trial and followed-up with, including after trial termination.	27.3% 3/11 • Number of events 3 • 12 months Low-risk device - Adverse events and serious adverse events were collected throughout the trial and followed-up with, including after trial termination.
Gastrointestinal disorders Nausea	27.3% 3/11 • Number of events 4 • 12 months Low-risk device - Adverse events and serious adverse events were collected throughout the trial and followed-up with, including after trial termination.	18.2% 2/11 • Number of events 2 • 12 months Low-risk device - Adverse events and serious adverse events were collected throughout the trial and followed-up with, including after trial termination.

Additional Information

Paul McGeoch, MD

Neurovalens Ltd

Phone: 858-232-3312

Email: paul.mcgeoch@neurovalens.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place