Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Major Depressive Disorder (MDD)
NCT Number: NCT06470035
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Major Depressive Disorder \(MDD|Depressive Disorder, Major
Interventions: DEVICE: Active VeNS Device|DEVICE: Sham VeNS Device
Sponsor: Neurovalens Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 170
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-04
Completion Date: 2027-04
Locations: VA San Diego Healthcare System, San Diego, California, 92161, United States|Biomedical Science Research University of Ulster, Coleraine, Belfast, Co.Antrim, BT52 1SA, United Kingdom

Summary:
Trial title: A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate the Efficacy of Electrical Vestibular Nerve Stimulation (VeNS), Compared to a Sham Control for Treatment of Major Depressive Disorder (MDD) - Modius Mood Study

The aim of this study: To better evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS) as a method of treating major depressive disorder(MDD) , 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

Primary Outcome Measures: Hamilton Depression Rating Scale (HDRS-17), The HDRS (also known as the HAM-D) is the most widely used clinician-administered depression assessment scale. The original version contains 17 items (HDRS-17) pertaining to symptoms of depression experienced over the past week. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale. The HDRS-17 scoring shall be the Primary Outcome of the study and will be completed at baseline and each study visit., Change in score from baseline to 6 weeks|Hamilton Depression Rating Scale (HDRS-17), The HDRS (also known as the HAM-D) is the most widely used clinician-administered depression assessment scale. The original version contains 17 items (HDRS-17) pertaining to symptoms of depression experienced over the past week. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale. The HDRS-17 scoring shall be the Primary Outcome of the study and will be completed at baseline and each study visit. The proportion (%) of participants achieving the HDRS-17 minimal clinically important difference (≥3 point reduction) by the 6-week time point between the active and sham groups., 6 weeks
Secondary Outcome Measures: WHO Disability Assessment Schedule 2.0 (WHODAS2), The WHO Disability Assessment Schedule 2.0 is a standardized assessment tool developed by the World Health Organization (WHO) to measure general health, disability levels and impairment across various domains of functioning, including mental and neurological disorders. It is designed to assess the impact of health conditions and disabilities on an individual's ability to participate in various life activities. The WHODAS 2.0 shall be a secondary outcome of this study, and will be completed at the baseline visit and repeated at each visit., Change in score from baseline to 6 weeks|Insomnia Severity Index (ISI), The Insomnia Severity Index (ISI) is a validated short, self-report screening assessment tool designed to evaluate insomnia by measuring an individual's perception of both day and night symptoms of insomnia. The Index consists of seven items which are each assessed in terms of perceived difficulty: falling sleep, staying asleep, and time of awakening, satisfaction with current sleep pattern, interference with daily functioning, noticeability by others of impact of lack of sleep, and degree of perceived distress or concern caused by the sleep problem. The ISI shall be a secondary outcome of the study and be completed at baseline and 6 weeks., Change in score from baseline to 6 weeks|Quality of Life (EQ-5D-5L), The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each level is rated on scale that describes the degree of problems in that area. The tool also has an overall health scale where the rater selects a number between 1-100 to describe the condition of their health, 100 being the best imaginable. The EQ-5L-5D shall be completed at baseline and at 6 weeks. The EQ-5L-5D has previously been tested for reliability and validity., Change in score from baseline to 6 weeks|Hamilton Depression Rating Scale (HDRS-17), The HDRS (also known as the HAM-D) is the most widely used clinician-administered depression assessment scale. The original version contains 17 items (HDRS-17) pertaining to symptoms of depression experienced over the past week. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale., Change in score at 4 week post-intervention timepoint|WHO Disability Assessment Schedule 2.0 (WHODAS2), The WHO Disability Assessment Schedule 2.0 is a standardized assessment tool developed by the World Health Organization (WHO) to measure general health, disability levels and impairment across various domains of functioning, including mental and neurological disorders. It is designed to assess the impact of health conditions and disabilities on an individual's ability to participate in various life activities. The WHODAS 2.0 shall be a secondary outcome of this study, and will be completed at the baseline visit and repeated at each visit, Change in score at 4 week post-intervention timepoint