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.
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
62
Battery powered non-invasive neurostimulation device
Placebo comparator sham device (no active stimulation)
NRI Institute of Medical Sciences
Visakhapatnam, Andhra Pradesh, India
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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
Time frame: 8 weeks
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