Electrical Vestibular Nerve Stimulation (VeNS) As a Treatment for Depression
NCT ID: NCT06051864
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
62 participants
INTERVENTIONAL
2023-12-03
2024-11-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active VeNS
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.
Modius Mood Active Device
Battery powered non-invasive neurostimulation device
Sham VeNS
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.
Sham Device
Placebo comparator sham device (no active stimulation)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Modius Mood Active Device
Battery powered non-invasive neurostimulation device
Sham Device
Placebo comparator sham device (no active stimulation)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
* 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)
18 Years
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NRI Institute of Medical Sciences
UNKNOWN
Neurovalens Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sai Sailesh Kumar Goothy
Role: PRINCIPAL_INVESTIGATOR
NRI Institute of Medical Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
NRI Institute of Medical Sciences
Visakhapatnam, Andhra Pradesh, India
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MMS001
Identifier Type: -
Identifier Source: org_study_id