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

Depression Clinical Trial

Official title:

Effectiveness of Electrical Vestibular Nerve Stimulation in the Management of Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06051864
• Other study ID #: MMS001
• Status: Recruiting
• Phase: N/A
• Start date: December 3, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: June 2024
• Source: Neurovalens Ltd.
• Contact: Rachel Robinson
• Phone: 2890991835
• Email: trials[@]neurovalens.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• Modius Mood Active Device
Battery powered non-invasive neurostimulation device
• Sham Device
Placebo comparator sham device (no active stimulation)

Locations

Country	Name	City	State
India	NRI Institute of Medical Sciences	Visakhapatnam	Andhra Pradesh

Sponsors (2)

Lead Sponsor	Collaborator
Neurovalens Ltd.	NRI Institute of Medical Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	An evaluation of the safety of the Modius Mood device will be quantified by the occurrence in adverse events between the active and control group during the study period	8 weeks
Primary	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	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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	8 weeks