Electrical Vestibular Nerve Stimulation (VeNS) As a Treatment for Depression

NCT06051864 | Completed

• 1 other identifier: MMS001
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  8 weeks

• To evaluate the impact of the Modius Mood device, relative to the control group, on anxiety at 4 weeks and 8 weeks

  8 weeks

• To evaluate the impact of the Modius Mood device, relative to the control group, on insomnia at 4 weeks and 8 weeks

  8 weeks

• To evaluate the effect of the Modius Mood, relative to control group, on quality of life at 4 weeks and 8 weeks

  8 weeks

Other Outcomes (1)

• To evaluate the safety of the Modius Mood device, relative to control group, in terms of the occurrence of adverse events for the duration of the study

  8 weeks

Study Arms (2)

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.

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.

Device: Sham Device

Interventions

Modius Mood Active Device DEVICE

Battery powered non-invasive neurostimulation device

Active VeNS

Sham Device DEVICE

Placebo comparator sham device (no active stimulation)

Sham VeNS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Neurovalens Ltd.: lead
• NRI Institute of Medical Sciences: collaborator

Study Sites (1)

NRI Institute of Medical Sciences

Visakhapatnam, Andhra Pradesh, 531163, India

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Sai Sailesh Kumar Goothy

  NRI Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: December 3, 2023
• Primary Completion: November 5, 2024
• Study Completion: November 5, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

IN (1)