Device for Treating Generalized Anxiety
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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
Eligibility
Primary outcome measure(s)
- Evaluation of the change in self-reported anxiety symptoms 3 months post-treatment. — Baseline and 3 months
Evaluation of the change in self-reported anxiety symptoms based on the Generalized Anxiety Disorder Assessment (GAD-7). The GAD-7 baseline score will be compared to the 3-month follow-up score. The 3-month score change will be compared between the active and sham groups. Subjects rate seven symptoms based on their frequency over the preceding two-week period. Each item is scored from 0 (not at all) to 3 (nearly every day), resulting in a total score range of 0 to 21, with higher scores indicating greater anxiety severity.
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Aria Integrative Health | Denver | Colorado | Recruiting |
| The Study by AC | Chicago | Illinois | Recruiting |
| Cady Wellness Institute | Newburgh | Indiana | Recruiting |
More BTL Industries Ltd. trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07819773 on ClinicalTrials.gov ↗ ← All trials in the USA