Description Module

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Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module

Ignite Creation Date: 2025-12-25 @ 3:11 AM
Ignite Modification Date: 2025-12-25 @ 3:11 AM
NCT ID: NCT06956105
Brief Summary: Trial title: A Randomized, Double-blind Sham-controlled Clinical Trial to Evaluate The Efficacy of Electrical Vestibular Stimulation (VeNS), Compared to a Sham Control For The Management Of Anxiety in Adolescents - The Modius Calm Adolescent Study The aim of this study: This investigation aims to evaluate the effects of VeNS for the treatment of Generalized Anxiety Disorder, to contribute to the field of knowledge about the neurological mechanisms to determine whether the relatively inexpensive, and non-invasive technique of VeNS can reduce the severity of GAD symptoms in adolescents. 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 BGS MCH Hospital. 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 clinic. 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) * End of Study (4-week timepoint) * Post-intervention follow-up at 2 weeks (6-week timepoint) * Post-intervention follow-up at 6 weeks (10-week timepoint) * Post-intervention follow-up at 8 weeks (12-week timepoint)
Study: NCT06956105
Study Brief:
Protocol Section: NCT06956105