Device for Treating Generalized Anxiety

NCT07819773 | Recruiting FDA Device

• 1 other identifier: BTL-699_CTUS600
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Generalized Anxiety Disorder (GAD)

Outcome Measures

Primary Outcomes (1)

• Evaluation of the change in self-reported anxiety symptoms 3 months post-treatment.

  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.

  Baseline and 3 months

Secondary Outcomes (8)

• Evaluation of the change in self-reported depressive symptoms.

  baseline and 3 monhts

• Evaluation of the change in clinician-reported anxiety symptoms.

  baseline and 3 months

• Evaluation of clinician's impression of improvement.

  baseline and 3 months

• Evaluation of the self-reported impression of improvement

  baseline and 3 months

• Evaluation of the change in mental well-being

  Baseline and 3 months

Study Arms (2)

Treatment with BTL-699-2

EXPERIMENTAL

Participants will receive active treatment with BTL-699-2, at an intensity of 80% of motor threshold

Device: EXOMIND (BTL-699-2) Active treatment

Sham Treatment with BTL-699-2

SHAM COMPARATOR

Participants will receive sham treatment with BTL-699-2, at an intensity of 5% of motor threshold

Device: EXOMIND (BTL-699-2) Sham treatment

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.

Treatment with BTL-699-2

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.

Sham Treatment with BTL-699-2

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 22 years
• A diagnosis of GAD according to DSM-5 criteria, confirmed by a qualified clinician at screening
• Ability to determine the motor threshold of the participant. The participant's motor threshold could be established as the minimum stimulus required to induce contraction of the right thumb
• Subjects willing and able to abstain from partaking in any treatments other than the pre-procedure therapy regime for the treatment of anxiety, including non-invasive brain stimulation treatments other than the study procedure during study participation
• Willingness to comply with study instructions and to return to the clinic for the required visits
• Women of child-bearing potential\* are required to use birth control measures during the whole duration of the study
• If applicable, subjects must be maintained on their pre-study psychotherapeutic regimen and any prescribed chronic medications at a stable therapeutic dose for ≥4 weeks prior to enrollment, with no dose or usage frequency changes permitted during the study
• Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.

You may not qualify if:

• Metallic objects in or near the head rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head or within 12 in (30 cm) of the treatment coil.\*
• Implanted stimulator devices
• Active or inactive implants (including device leads), including deep brain stimulators, cochlear implants, ocular implants and vagus nerve stimulators. Contraindicated use could result in serious injury or death.
• Drug pumps
• Application in the heart area
• Persons with a tendency to seizure (e.g., persons suffering from hypotonia and epilepsy)
• Anticoagulation therapy
• Severe or life-threatening condition
• Pulmonary insufficiency
• Heart disorders
• Renal insufficiency
• Decompensated\*\* hemorrhagic conditions
• Decompensated\*\* blood coagulation disorders
• Decompensated\*\* cardiovascular diseases
• Malignant tumor or benign tumor

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (3)

Aria Integrative Health

Denver, Colorado, 80211, United States

RECRUITING

The Study by AC

Chicago, Illinois, 60611, United States

RECRUITING

Cady Wellness Institute

Newburgh, Indiana, 47630, United States

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 15, 2026
• Study Start: September 9, 2026
• Primary Completion (Estimated): April 9, 2027
• Study Completion (Estimated): April 9, 2027
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)