Clinical trial NCT06051864: Electrical Vestibular Nerve Stimulation (VeNS) As a Treatment for Depression
Official title: Effectiveness of Electrical Vestibular Nerve Stimulation in the Management of Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Neurovalens Ltd.
Sponsor class: INDUSTRY
Collaborators: name: NRI Institute of Medical Sciences
First posted: 2023-09-25
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Eligibility criteria: 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)

Primary outcomes:
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
timeFrame: 8 weeks
Secondary outcomes:
measure: 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
timeFrame: 8 weeks
measure: To evaluate the impact of the Modius Mood device, relative to the control group, on anxiety at 4 weeks and 8 weeks
timeFrame: 8 weeks
measure: To evaluate the impact of the Modius Mood device, relative to the control group, on insomnia at 4 weeks and 8 weeks
timeFrame: 8 weeks
measure: To evaluate the effect of the Modius Mood, relative to control group, on quality of life at 4 weeks and 8 weeks
timeFrame: 8 weeks
Other outcomes:
measure: 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
timeFrame: 8 weeks
Locations:
city: Visakhapatnam
country: India
facility: NRI Institute of Medical Sciences
state: Andhra Pradesh
Study officials:
affiliation: NRI Institute of Medical Sciences
name: Sai Sailesh Kumar Goothy
role: PRINCIPAL_INVESTIGATOR
References: