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Clinical Trial

Device for Treating Generalized Anxiety

NCT: NCT07819773 · RECRUITING

NCT IDNCT07819773
StatusRECRUITING
Start Date2026-09-09
Completion2027-04-09
SponsorBTL Industries Ltd. (INDUSTRY)
First posted
Last updated

Brief Summary

The goal of this clinical trial is to learn if treatment with the BTL-699-2 device (non-invasive repetitive transcranial magnetic stimulation) can decrease anxiety symptoms in adults (aged 22 years and older) diagnosed with Generalized Anxiety Disorder (GAD). The main questions it aims to answer are: Does the accelerated treatment protocol using the BTL-699-2 device reduce self-reported anxiety symptoms (as measured by the GAD-7 scale) 3 months after the final treatment? What are the safety and side effects associated with the use of the BTL-699-2 device during this accelerated protocol? Researchers will compare the active treatment group (Group A, receiving stimulation intensity of up to 70% of the individual's motor threshold) to a sham control group (Group B, receiving an inactive stimulation intensity of 5% of their motor threshold) to see if the active brain stimulation works to treat Generalized Anxiety Disorder. Participants will: * Attend a screening/baseline visit to confirm GAD diagnosis (using the MINI diagnostic interview), review medical history, and establish their individual motor threshold. * Complete 8 study treatment visits scheduled twice weekly (2 to 4 days apart) over approximately 4 weeks. Each visit will consist of two consecutive 19-minute treatment sessions delivered at least 15 minutes apart (for a total of 16 treatments). * Complete self-reported and clinician-reported questionnaires assessing anxiety (GAD-7, HAM-A), depressive symptoms (PHQ-9), well-being (WEMWBS), suicidal risk (CSSRS), clinical improvement (CGI-I, PGI-I), and treatment comfort/satisfaction (TCQ, SSQ) at designated baseline, treatment, and follow-up visits. * Undergo a urine pregnancy test at baseline and once weekly (every other treatment visit) if they are women of childbearing potential. * Attend 2 follow-up visits scheduled at 1 month and 3 months after the final treatment to evaluate long-term outcomes and safety

Frequently Asked Questions

What is Device for Treating Generalized Anxiety?

Device for Treating Generalized Anxiety is a clinical trial registered under NCT07819773. Current status: RECRUITING.

What is the status of NCT07819773?

The current status of NCT07819773 (Device for Treating Generalized Anxiety) is: RECRUITING.

When did Device for Treating Generalized Anxiety start?

Device for Treating Generalized Anxiety started on 2026-09-09.

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Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.