Major Depressive Disorder \(MDDNCT06470035
Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Major Depressive Disorder (MDD)
A study testing Active VeNS Device in people with Major Depressive Disorder \(MDD and Depressive Disorder, Major, run by Neurovalens Ltd. at 2 sites in 2 countries.
Trial summary
Trial title: A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate the Efficacy of Electrical Vestibular Nerve Stimulation (VeNS), Compared to a Sham Control for Treatment of Major Depressive Disorder (MDD) - Modius Mood Study The aim of this study: To better evaluate the efficacy of non-invasive… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Major Depressive Disorder \(MDD, Depressive Disorder, Major
- What is being tested?
- Active VeNS Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent
- Adults, (US ≥ 22 years and ≤ 80 years, UK ≥ 18 years and ≤ 80 years) male or female at the time of signing informed consent
- Beck's Depression Inventory-ll (BDI-ll) score of ≥ 14 at Screening
- Established diagnosis of depression as confirmed at the time of screening by the Mini-International Neuropsychiatric Interview (MINI)
- A Generalized Anxiety Disorder (GAD-7) score \<10 at screening
- On anti-depressant medication to treat depression (participant must only be on one Selective Serotonin or Norepinephrine Reuptake Inhibitor (SSRI/SNRI) for at least 1 year prior to baseline visit, and no longer than 5 years)
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- Stable dose of current prescribed antidepressant (SSRI/SNRI) medication to treat depression, 3 months prior to baseline appointment
- Maintain a stable prescribed medication and/or treatment regime to treat depression for the duration of the trial
- No change in regular medication for the duration of the trial (unless directed by a health care provider).
- Can speak / read English
- Ability and willingness to complete all study visits and procedures; in particular an agreement to engage with trying to use the device per the study protocol
- Ability and willingness to adhere to 30 minutes usage of the device daily for the duration of the trial
- Access to Wi-Fi for the duration of the study
- Access to a computer, laptop, iPad, tablet or smartphone (to complete study visits and complete online study questionnaires)
- Willingness to use a video calling platform to conduct remote study visits
- Agree not to undergo any extreme lifestyle changes during the duration of the study that could impact mood e.g. dietary , exercise changes
- Agree not to begin any complimentary or alternative therapies that may affect your mood during the time on the study e.g use of mental health apps, CBT
Who cannot join
- Risk of persistent self-harm or suicide as confirmed by the Columbia Suicide Severity Rating Scale (CSSRS)
- Diagnosis or history of bipolar disorder
- History of or a current psychotic disorder such as schizophrenia or other non-mood disorder psychosis
- Diagnosis of substance use disorder within the past 12 months or current substance use dependence
- Use of recreational drugs (e.g nalgesics, depressants, stimulants, and hallucinogens). Subject can enrol after a washout period of 30 days
- Female who is pregnant or breast-feeding
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- History of diagnosed cognitive impairment / disorder such as delirium or dementia
- Previous or current diagnosis of a chronic viral infection, for example hepatitis or HIV (potential damage to vestibular system, known as vestibular neuropathy).
- History of stroke or head injury requiring intensive care or neurosurgery (potential damage to neurological pathways affected by vestibular stimulation)
- Presence of permanently implanted batterypowered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator, etc.)
- History of epilepsy
- History of severe tinnitus or vertigo
- History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
- History or presence of malignancy within the last year (except basal and squamous cell skin cancer and in-situ carcinomas)
- History of vestibular dysfunction or another inner ear disease
- Regular use (more than twice a month) of antihistamine medication within the last 6 months. The subject can opt to switch to Fexofenadine (non-drowsy) and may enrol after a wash-out period of 2 weeks
- Diagnosis of active migraines
- Previous use of Modius device or any VeNS device
- Participation in other clinical trials sponsored by Neurovalens
- Participation in any other depression studies at the time of enrolment and throughout this study duration
- Any other medical condition, or medication use, that in the opinion of the PI is likely to make the subject refractory to VeNS.
- Failure to use device daily during trial participation (no more than 14 consecutive days usage drop without reasonable explanation)
- Persistent failure to comply with study protocol and procedures
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site
VA San Diego Healthcare System
San Diego, California, 92161
Peter Colvonen, 442-369-7964, trials@neurovalens.com
Peter Colvonen
United Kingdom1 site
Biomedical Science Research University of Ulster, Coleraine
Belfast, Co.Antrim, BT52 1SA
Julie Sittlington, 2890991835, trials@neurovalens.com
Julie Sittlington
About this study
Official title: A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate the Efficacy of Electrical Vestibular Nerve Stimulation (VeNS), Compared to a Sham Control for Treatment of Major Depressive Disorder (MDD) - Modius Mood Study
Trial title: A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate the Efficacy of Electrical Vestibular Nerve Stimulation (VeNS), Compared to a Sham Control for Treatment of Major Depressive Disorder (MDD) - Modius Mood Study
The aim of this study: To better evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS) as a method of treating major depressive disorder(MDD) , as compared to a sham control.
Allocation: Randomized to either active device or control device usage.
Endpoint classification: Efficacy Study Intervention Model: Parallel Assignment in 1:1 active to control allocation
- Being tested
- Active VeNS Device, Sham VeNS Device
- Keywords
- VeNS, Depression, MDD, Vestibular stimulation
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active VeNS DeviceDevice
Also called Modius Mood
Battery powered non-invasive neurostimulation device
Sham VeNS DeviceDevice
Placebo comparator sham device (no active stimulation)
| Study group | Role | What they receive |
|---|---|---|
| Active VeNS | Experimental | 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. Receives: Device: Active VeNS Device |
| Sham VeNS | Sham comparator | 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. Receives: Device: Sham VeNS Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HDRS-17)
The HDRS (also known as the HAM-D) is the most widely used clinician-administered depression assessment scale. The original version contains 17 items (HDRS-17) pertaining to symptoms of depression experienced over the past week. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale. The HDRS-17 scoring shall be the Primary Outcome of the study and will be completed at baseline and each study visit.
Measured: Change in score from baseline to 6 weeks
Hamilton Depression Rating Scale (HDRS-17)
The HDRS (also known as the HAM-D) is the most widely used clinician-administered depression assessment scale. The original version contains 17 items (HDRS-17) pertaining to symptoms of depression experienced over the past week. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale. The HDRS-17 scoring shall be the Primary Outcome of the study and will be completed at baseline and each study visit. The proportion (%) of participants achieving the HDRS-17 minimal clinically important difference (≥3 point reduction) by the 6-week time point between the active and sham groups.
Measured: 6 weeks
Secondary outcomes (5)
WHO Disability Assessment Schedule 2.0 (WHODAS2)
The WHO Disability Assessment Schedule 2.0 is a standardized assessment tool developed by the World Health Organization (WHO) to measure general health, disability levels and impairment across various domains of functioning, including mental and neurological disorders. It is designed to assess the impact of health conditions and disabilities on an individual's ability to participate in various life activities. The WHODAS 2.0 shall be a secondary outcome of this study, and will be completed at the baseline visit and repeated at each visit.
Measured: Change in score from baseline to 6 weeks
Insomnia Severity Index (ISI)
The Insomnia Severity Index (ISI) is a validated short, self-report screening assessment tool designed to evaluate insomnia by measuring an individual's perception of both day and night symptoms of insomnia. The Index consists of seven items which are each assessed in terms of perceived difficulty: falling sleep, staying asleep, and time of awakening, satisfaction with current sleep pattern, interference with daily functioning, noticeability by others of impact of lack of sleep, and degree of perceived distress or concern caused by the sleep problem. The ISI shall be a secondary outcome of the study and be completed at baseline and 6 weeks.
Measured: Change in score from baseline to 6 weeks
Quality of Life (EQ-5D-5L)
The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each level is rated on scale that describes the degree of problems in that area. The tool also has an overall health scale where the rater selects a number between 1-100 to describe the condition of their health, 100 being the best imaginable. The EQ-5L-5D shall be completed at baseline and at 6 weeks. The EQ-5L-5D has previously been tested for reliability and validity.
Measured: Change in score from baseline to 6 weeks
Hamilton Depression Rating Scale (HDRS-17)
The HDRS (also known as the HAM-D) is the most widely used clinician-administered depression assessment scale. The original version contains 17 items (HDRS-17) pertaining to symptoms of depression experienced over the past week. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale.
Measured: Change in score at 4 week post-intervention timepoint
WHO Disability Assessment Schedule 2.0 (WHODAS2)
The WHO Disability Assessment Schedule 2.0 is a standardized assessment tool developed by the World Health Organization (WHO) to measure general health, disability levels and impairment across various domains of functioning, including mental and neurological disorders. It is designed to assess the impact of health conditions and disabilities on an individual's ability to participate in various life activities. The WHODAS 2.0 shall be a secondary outcome of this study, and will be completed at the baseline visit and repeated at each visit
Measured: Change in score at 4 week post-intervention timepoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study startApr 2025 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder \(MDDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurovalens Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Colvonen, Principal investigator, San Diego Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470035
- Sponsor's protocol ID
- MMS002
- Status last verified
- Aug 2024
- First submitted
- 14 Jun 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate the Efficacy of Electrical Vestibular Nerve Stimulation (VeNS), Compared to a Sham Control for Treatment of Major Depressive Disorder (MDD) - Modius Mood Study
- ClinicalTrials.gov ID
- NCT06470035
- Acronym / sponsor ID
- MMS002
- Keywords
- VeNS, Depression, MDD, Vestibular stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Neurovalens Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2025 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Trial title: A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate the Efficacy of Electrical Vestibular Nerve Stimulation (VeNS), Compared to a Sham Control for Treatment of Major Depressive Disorder (MDD) - Modius Mood Study
The aim of this study: To better evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS) as a method of treating major depressive disorder(MDD) , as compared to a sham control.
Allocation: Randomized to either active device or control device usage.
Endpoint classification: Efficacy Study Intervention Model: Parallel Assignment in 1:1 active to control allocation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active VeNS | Experimental | Device: Active VeNS DeviceThe 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. |
| Sham VeNS | Sham comparator | Device: Sham VeNS DeviceThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Signed Informed Consent
- Adults, (US ≥ 22 years and ≤ 80 years, UK ≥ 18 years and ≤ 80 years) male or female at the time of signing informed consent
- Beck's Depression Inventory-ll (BDI-ll) score of ≥ 14 at Screening
- Established diagnosis of depression as confirmed at the time of screening by the Mini-International Neuropsychiatric Interview (MINI)
- A Generalized Anxiety Disorder (GAD-7) score \<10 at screening
Key exclusion criteria (23 listed)
- Risk of persistent self-harm or suicide as confirmed by the Columbia Suicide Severity Rating Scale (CSSRS)
- Diagnosis or history of bipolar disorder
- History of or a current psychotic disorder such as schizophrenia or other non-mood disorder psychosis
- Diagnosis of substance use disorder within the past 12 months or current substance use dependence
- Use of recreational drugs (e.g nalgesics, depressants, stimulants, and hallucinogens). Subject can enrol after a washout period of 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active VeNS DeviceAlso: Modius MoodBattery powered non-invasive neurostimulation device | Device | Active VeNS |
| Sham VeNS DevicePlacebo comparator sham device (no active stimulation) | Device | Sham VeNS |
Primary outcome
Hamilton Depression Rating Scale (HDRS-17)
Time frame: Change in score from baseline to 6 weeks
The HDRS (also known as the HAM-D) is the most widely used clinician-administered depression assessment scale. The original version contains 17 items (HDRS-17) pertaining to symptoms of depression experienced over the past week. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale. The HDRS-17 scoring shall be the Primary Outcome of the study and will be completed at baseline and each study visit.
Hamilton Depression Rating Scale (HDRS-17)
Time frame: 6 weeks
The HDRS (also known as the HAM-D) is the most widely used clinician-administered depression assessment scale. The original version contains 17 items (HDRS-17) pertaining to symptoms of depression experienced over the past week. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale. The HDRS-17 scoring shall be the Primary Outcome of the study and will be completed at baseline and each study visit. The proportion (%) of participants achieving the HDRS-17 minimal clinically important difference (≥3 point reduction) by the 6-week time point between the active and sham groups.
5 secondary outcomes
WHO Disability Assessment Schedule 2.0 (WHODAS2)
Time frame: Change in score from baseline to 6 weeks
Insomnia Severity Index (ISI)
Time frame: Change in score from baseline to 6 weeks
Quality of Life (EQ-5D-5L)
Time frame: Change in score from baseline to 6 weeks
Hamilton Depression Rating Scale (HDRS-17)
Time frame: Change in score at 4 week post-intervention timepoint
WHO Disability Assessment Schedule 2.0 (WHODAS2)
Time frame: Change in score at 4 week post-intervention timepoint
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Colvonen principal investigator
San Diego Healthcare System
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active VeNS Device in people with Major Depressive Disorder \(MDD and Depressive Disorder, Major, run by Neurovalens Ltd. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joe Reel (02890991835 ext. +44, trials@neurovalens.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale (HDRS-17) (time frame: Change in score from baseline to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.