Device for Treating Generalized Anxiety

Conditions

• Generalized Anxiety Disorder (GAD)

Eligibility Criteria

Sex

ALL

Age

22 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• EXOMIND (BTL-699-2) Active treatment — DEVICE
  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 — DEVICE
  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 Details

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

Key Dates

First listed

Sep 15, 2026

Start date

Sep 9, 2026

Status verified

Sep 2026

Primary completion

Apr 9, 2027

Completion

Apr 9, 2027

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment with BTL-699-2
  Participants will receive active treatment with BTL-699-2, at an intensity of 80% of motor threshold
• Sham Comparator: Sham Treatment with BTL-699-2
  Participants will receive sham treatment with BTL-699-2, at an intensity of 5% of motor threshold

Primary Outcome Measure

Evaluation of the change in self-reported anxiety symptoms 3 months post-treatment. [ Time Frame: Baseline and 3 monhts ]

Locations (3)

Find similar trials in Denver, CO

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