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Behavioural Intervention

Electrical Nerve Stimulation for Depression

N/A

Waitlist Available

Led By Peter Colvonen

Research Sponsored by Neurovalens Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults male or female aged 22 to 80 years in the US and 18 to 80 years in the UK at the time of signing informed consent

Stable dose of current prescribed antidepressant (SSRI/SNRI) medication for 3 months prior to baseline appointment

Must not have

History of skin conditions affecting the skin behind the ears

History or presence of malignancy within the last year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in score from baseline to 6 weeks

Summary

This trial aims to test the effectiveness of a non-invasive treatment called Electrical Vestibular Nerve Stimulation (VeNS) for Major Depressive Disorder (MDD). Participants will be randomly assigned

Who is the study for?

This trial is for individuals with Major Depressive Disorder (MDD) who are seeking a new treatment option. Participants should not have other mental health conditions that could interfere with the study, and they must be willing to use either the active VeNS device or a sham (placebo) device as determined by chance.

What is being tested?

The study tests if an electrical vestibular nerve stimulation (VeNS) device can help treat depression compared to a sham device. Participants will be randomly assigned to receive either the real VeNS treatment or a placebo, in equal numbers, over a period of 10 weeks.

What are the potential side effects?

Possible side effects of using the VeNS device may include discomfort at the site of application, headache, dizziness, or nausea. However, since this is an investigational study, there may be some unknown risks as well.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 22 and 80 years old in the US, or 18 and 80 in the UK.

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I've been on the same dose of my antidepressant for at least 3 months.

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I won't change my regular medications during the trial unless my doctor advises.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had skin conditions behind my ears.

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I have had cancer within the last year.

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I have had issues with my inner ear or balance.

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I am not pregnant or breastfeeding.

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I have been diagnosed with a cognitive disorder like dementia.

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I have been diagnosed with a chronic viral infection like hepatitis or HIV.

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I have had a stroke or head injury that needed intensive care or surgery.

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I have a history of epilepsy.

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I use antihistamines more than twice a month.

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I have been diagnosed with active migraines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in score from baseline to 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in score from baseline to 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in score from baseline to 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Hamilton Depression Rating Scale (HDRS-17)

Insomnia Severity Index (ISI)

Quality of Life (EQ-5D-5L)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active VeNSExperimental Treatment1 Intervention

The active device utilizes a technology 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 30 minutes per day.

Group II: Sham VeNSPlacebo Group1 Intervention

The sham device looks identical to the active device and interacts with the app in a similar manner to the active device. 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 30 minutes per day.

0 / 13Eligibility criteria met