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Recruiting Not applicable Interventional

Device for Treating Generalized Anxiety

ClinicalTrials.gov ID: NCT07819773

Public ClinicalTrials.gov record NCT07819773. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 25, 2026, 4:51 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Evaluation of the Efficacy and Safety of an Accelerated Protocol for Treating Generalized Anxiety Disorder Using the BTL-699-2 Device

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT07819773
Recruitment status
Recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
BTL Industries Ltd.
Industry
Enrollment
40 participants

Conditions and interventions

Eligibility (public fields only)

Age range
22 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 8, 2026
Primary completion
Apr 8, 2027
Completion
Apr 8, 2027
Last update posted
Sep 17, 2026

2026 – 2027

United States locations

U.S. sites
3
U.S. states
3
U.S. cities
3
Facility City State ZIP Site status
Aria Integrative Health Denver Colorado 80211 Recruiting
The Study by AC Chicago Illinois 60611 Recruiting
Cady Wellness Institute Newburgh Indiana 47630 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07819773, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 17, 2026 · Synced Sep 25, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07819773 live on ClinicalTrials.gov.

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