40 Participants NeededMy employer runs this trial

EXOMIND Device for Anxiety

Recruiting at 2 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: BTL Industries Ltd.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

This trial is for adults aged 22 and older who have been diagnosed with Generalized Anxiety Disorder. Participants must be able to attend multiple treatment sessions over about a month and follow-up visits up to three months later.

Inclusion Criteria

Women of child-bearing potential are required to use birth control measures during the whole duration of the study
Willingness to comply with study instructions and to return to the clinic for required visits
I have been diagnosed with GAD by a clinician using DSM-5 criteria.
See 4 more

Exclusion Criteria

Substance abuse
Active suicidal intent defined by Level 4 or 5 on Columbia-Suicide Severity Rating Scale (CSSRS)
Drug pumps
See 27 more

What Are the Treatments Tested in This Trial?

Interventions

  • EXOMIND (BTL-699-2) Active treatment

Trial Overview

The study tests the BTL-699-2 device, which uses non-invasive brain stimulation (rTMS), to see if it reduces anxiety symptoms. Participants are randomly assigned to get either active or sham (inactive) treatments in a double-blind design.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment with BTL-699-2Experimental Treatment1 Intervention
Group II: Sham Treatment with BTL-699-2Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

BTL Industries Ltd.

Lead Sponsor

Trials
59
Recruited
2,000+