DepressionNCT06051864
Electrical Vestibular Nerve Stimulation (VeNS) As a Treatment for Depression
A study testing Modius Mood Active Device in people with Depression, run by Neurovalens Ltd. at 1 site in India.
Trial summary
Trial title: Effectiveness of Electrical Vestibular Nerve Stimulation in the Management of Depression The aim of this study: To better evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS) as a method of treating Depression, as compared to a sham control. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Modius Mood Active Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteIndia
- Study dates
- 3 Dec 2023to 5 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed Informed Consent
- Male or female, age ≥ 18 years and ≤ 80 years at the time of signing informed consent
- PHQ-9 score of >/=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
- Stable dose of anti-depressant (SSRI/SNRI) medication to treat depression, 3 months prior to baseline appointment
- Stable medication regime for at least 4 weeks prior to the baseline visit
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- Can speak / read Hindi / 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 at 5 days per week for the duration of the trial at clinic
- Agree not to undergo any extreme lifestyle changes during the duration of the study that could impact sleep e.g. dietary or exercise changes
Who cannot join
- Patient Health Questionnaire-9 (PHQ-9) score of <10 at screening
- Risk of persistent self-harm or suicide
- Diagnosis or history of bipolar disorder
- History of a current psychotic disorder such as schizophrenia or other non-mood disorder psychosis
- Diagnosis of substance use disorder or dependence
- Use of recreational drugs (e.g nalgesics, depressants, stimulants, and hallucinogens). Subject can enrol after a washout period of 30 days
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- History of diagnosed cognitive impairment / disorder such as delirium or dementia
- Previous diagnosis of a chronic viral infection, for example hepatitis or HIV.
- History of stroke or head injury requiring intensive care or neurosurgery
- Presence of permanently implanted battery-powered 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
- A diagnosis of myelofibrosis or myelodysplastic syndrome
- Diagnosis of active migraines
- Previous use of Modius device or any VeNS device
- Participation in other clinical trials sponsored by Neurovalens
- 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)
Trial locations and contacts
1 site in 1 country.
India1 site
NRI Institute of Medical Sciences
Visakhapatnam, Andhra Pradesh, 531163
About this study
Official title: Effectiveness of Electrical Vestibular Nerve Stimulation in the Management of Depression
Trial title: Effectiveness of Electrical Vestibular Nerve Stimulation in the Management of Depression
The aim of this study: To better evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS) as a method of treating Depression, 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
Sample size: The aim is to recruit a total of up to 60 participants. The study will last 12 weeks in total for each subject.
Read the detailed description
This double blind randomized controlled trial will enroll up to 60 subjects and will be conducted at the NRI Institute of Medical Sciences. The study will be randomized for a 8-week period with a 1:1 active to sham device allocation. Each participant will complete 5 stimulation sessions per week under the supervision of a researcher at the Department of Physiology. Each session will be 30 minutes on the day of usage. The scheduled study events are to be undertaken at the following timepoints:
- Baseline: Study Visit 1 (0-week timepoint for enrolment)
- Study Visit 2 (2-week timepoint)
- Study Visit 3 (4-week timepoint)
- Study Visit 4 (6-week timepoint)
- End of Study: Study Visit 5 (8-week timepoint)
- Post-intervention follow-up at 4 weeks (12-week timepoint)
- Conditions
- Depression
- Being tested
- Modius Mood Active Device, Sham Device
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modius Mood Active DeviceDevice
Battery powered non-invasive neurostimulation device
Sham DeviceDevice
Placebo comparator sham device (no active stimulation)
| Study group | Role | What they receive |
|---|---|---|
| Active VeNS | Active comparator | 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: Modius Mood Active Device |
| Sham VeNS | Placebo comparator | The sham device looks identical to the active device and interacts with the app in a similar manner to the active device. It will apply some stimulation to a user for a limited period of time (30 seconds), before tapering down to zero over a further 20 seconds, thus creating the impression of an 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 Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the ability of the Modius Mood device, relative to the sham control group, in reducing the severity of depression at 8 weeks
Change in the Beck's Depression Inventory (BDI) score from baseline to 8 weeks between the active and control group.
Measured: 8 weeks
Secondary outcomes (4)
To evaluate the ability of the Modius Mood device, relative to the sham control group, in reducing the severity of depression at 2, 4 and 6 weeks
Change in the Beck's Depression Inventory (BDI) score at additional timepoints (2, 4, and 6 weeks) between the active and control group.
Measured: 8 weeks
To evaluate the impact of the Modius Mood device, relative to the control group, on anxiety at 4 weeks and 8 weeks
Change in the Generalized Anxiety Disorder Assessment (GAD-7) score from baseline to 4 weeks and 8 weeks between the active and control group.
Measured: 8 weeks
To evaluate the impact of the Modius Mood device, relative to the control group, on insomnia at 4 weeks and 8 weeks
Change in the Insomnia Severity Index (ISI) score from baseline to 4 weeks and 8 weeks between the active and control group.
Measured: 8 weeks
To evaluate the effect of the Modius Mood, relative to control group, on quality of life at 4 weeks and 8 weeks
Change in the Quality of Life (EQ-5D-5L) score from baseline to 4 weeks and 8 weeks between the active and control group
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start3 Dec 2023
- Primary completion5 Nov 2024
- Study completion5 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurovalens Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NRI Institute of Medical Sciences
- Responsible party
- Sponsor
- Investigators
- Sai Sailesh Kumar Goothy, Principal investigator, NRI Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051864
- Sponsor's protocol ID
- MMS001
- Status last verified
- Dec 2024
- First submitted
- 18 Sep 2023
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Electrical Vestibular Nerve Stimulation in the Management of Depression
- ClinicalTrials.gov ID
- NCT06051864
- Acronym / sponsor ID
- MMS001
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Neurovalens Ltd.Industry (pharma, biotech, devices)
- Collaborators
- NRI Institute of Medical Sciences
- Study start
- 3 Dec 2023 (actual)
- Primary completion
- 5 Nov 2024 (actual)
- Study completion
- 5 Nov 2024 (actual)
- First posted
- 25 Sep 2023 (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: Effectiveness of Electrical Vestibular Nerve Stimulation in the Management of Depression
The aim of this study: To better evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS) as a method of treating Depression, 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
Sample size: The aim is to recruit a total of up to 60 participants. The study will last 12 weeks in total for each subject.
Detailed description
This double blind randomized controlled trial will enroll up to 60 subjects and will be conducted at the NRI Institute of Medical Sciences. The study will be randomized for a 8-week period with a 1:1 active to sham device allocation. Each participant will complete 5 stimulation sessions per week under the supervision of a researcher at the Department of Physiology. Each session will be 30 minutes on the day of usage. The scheduled study events are to be undertaken at the following timepoints:
- Baseline: Study Visit 1 (0-week timepoint for enrolment)
- Study Visit 2 (2-week timepoint)
- Study Visit 3 (4-week timepoint)
- Study Visit 4 (6-week timepoint)
- End of Study: Study Visit 5 (8-week timepoint)
- Post-intervention follow-up at 4 weeks (12-week timepoint)
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 | Active comparator | Device: Modius Mood Active 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 | Placebo comparator | Device: Sham DeviceThe sham device looks identical to the active device and interacts with the app in a similar manner to the active device. It will apply some stimulation to a user for a limited period of time (30 seconds), before tapering down to zero over a further 20 seconds, thus creating the impression of an 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
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed Informed Consent
- Male or female, age ≥ 18 years and ≤ 80 years at the time of signing informed consent
- PHQ-9 score of >/=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
- Stable dose of anti-depressant (SSRI/SNRI) medication to treat depression, 3 months prior to baseline appointment
Key exclusion criteria (22 listed)
- Patient Health Questionnaire-9 (PHQ-9) score of <10 at screening
- Risk of persistent self-harm or suicide
- Diagnosis or history of bipolar disorder
- History of a current psychotic disorder such as schizophrenia or other non-mood disorder psychosis
- Diagnosis of substance use disorder or dependence
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 |
|---|---|---|
| Modius Mood Active DeviceBattery powered non-invasive neurostimulation device | Device | Active VeNS |
| Sham DevicePlacebo comparator sham device (no active stimulation) | Device | Sham VeNS |
Primary outcome
To evaluate the ability of the Modius Mood device, relative to the sham control group, in reducing the severity of depression at 8 weeks
Time frame: 8 weeks
Change in the Beck's Depression Inventory (BDI) score from baseline to 8 weeks between the active and control group.
4 secondary outcomes
To evaluate the ability of the Modius Mood device, relative to the sham control group, in reducing the severity of depression at 2, 4 and 6 weeks
Time frame: 8 weeks
To evaluate the impact of the Modius Mood device, relative to the control group, on anxiety at 4 weeks and 8 weeks
Time frame: 8 weeks
To evaluate the impact of the Modius Mood device, relative to the control group, on insomnia at 4 weeks and 8 weeks
Time frame: 8 weeks
To evaluate the effect of the Modius Mood, relative to control group, on quality of life at 4 weeks and 8 weeks
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Sai Sailesh Kumar Goothy principal investigator
NRI Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modius Mood Active Device in people with Depression, run by Neurovalens Ltd. at 1 site in India.
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 10 inclusion and 22 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: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the ability of the Modius Mood device, relative to the sham control group, in reducing the severity of depression at 8 weeks (time frame: 8 weeks). 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 20 Dec 2024; AzTrials last refreshed its copy on 6 Nov 2026.