Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06051864
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2023-09-18
Brief Title:
Electrical Vestibular Nerve Stimulation VeNS as a Treatment for Depression
Sponsor:
Neurovalens Ltd
Organization:
Neurovalens Ltd
Study Overview
Official Title:
Effectiveness of Electrical Vestibular Nerve Stimulation in the Management of Depression
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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
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 11 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 11 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None