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Device for Treating Generalized Anxiety
Sponsor: BTL Industries Ltd.
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
Official title: Evaluation of the Efficacy and Safety of an Accelerated Protocol for Treating Generalized Anxiety Disorder Using the BTL-699-2 Device
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-09-09
Completion Date
2027-04-09
Last Updated
2026-09-15
Healthy Volunteers
No
Conditions
Interventions
EXOMIND (BTL-699-2) Active treatment
Participants will receive sixteen transcranial magnetic stimulation treatment sessions during 8 treatment visits (each treatment visit will include two treatment sessions) with the BTL-699-2 device over the left dorsolateral prefrontal cortex. The intensity will be adjusted according to the subject's feedback, up to 80% of the individual's motor threshold. The treatment visits will be spaced 2 - 4 days apart.
EXOMIND (BTL-699-2) Sham treatment
Participants will receive sixteen transcranial magnetic stimulation treatment sessions during 8 treatment visits (each treatment visit will include two treatment sessions) with the BTL-699-2 device over the left dorsolateral prefrontal cortex. The intensity will be set to 5% of the individual's motor threshold. The treatment visits will be spaced 2 - 4 days apart.
Locations (3)
Aria Integrative Health
Denver, Colorado, United States
The Study by AC
Chicago, Illinois, United States
Cady Wellness Institute
Newburgh, Indiana, United States