Device for Treating Generalized Anxiety

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

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 Overview

• Status: Recruiting
• Conditions: Generalized Anxiety Disorder (GAD)
• Intervention / Treatment: Device: EXOMIND (BTL-699-2) Active treatment; Device: EXOMIND (BTL-699-2) Sham treatment

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80211
      • Recruiting
      • Aria Integrative Health
      • Contact: Henry Johnston III, MD; Phone Number: (720) 358-0725; Email: drjjohnston3md@gmail.com
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • The Study by AC
      • Contact: Charmi Patel, MD; Phone Number: (312) 883-6843; Email: charmi@astraculture.com
  • Indiana
    • Newburgh, Indiana, United States, 47630
      • Recruiting
      • Cady Wellness Institute
      • Contact: Louis Cady, MD; Phone Number: (812) 429-0772; Email: lbcady@cadywellness.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• Fever
• Pregnancy
• Active suicidal intent***
• History of suicide attempts in the last 3 years
• History or concurrent use of electroconvulsive therapy or vagus nerve stimulation
• Substance-induced depression or depression secondary to a general medical condition
• Seasonal affective disorder
• Substance abuse
• Substance dependence 3 months prior
• A psychotic disorder including schizoaffective disorder, bipolar disease, borderline personality disorder or major depression with psychotic features
• Neurological disorders, including a history of seizures, cerebrovascular disease, primary or secondary tumors in CNS, cerebral aneurysm, dementia, or movement disorders
• Ongoing intake disorders such as bulimia or anorexia, or intake disorder in the past fiscal year
• History of increased intracranial pressure or head trauma
• Nursing

• Any other disease or condition at the investigator's discretion that may pose risk to the patient or compromise the study

  • Examples include cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes. Failure to follow this restriction could result in serious injury or death. Certain exceptions apply to mouth implants, such as standard amalgam dental fillings, single post dental implants, dental bridge work, and braces. If these items are present, the therapy can still be administered.

    • By means of decompensation, it means a patient with a proven medical history of a decompensated health condition and long-term medication. Patients who use certain medications only for preventive purposes, without any proven previous health condition failure, are not considered contraindicated.

      • Defined by a score of Level 4 or Level 5 on the Columbia-Suicide Severity Rating Scale (CSSRS).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with BTL-699-2; Participants will receive active treatment with BTL-699-2, at an intensity of 80% of motor threshold	Device: 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.
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	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the change in self-reported depressive symptoms.	The change in the score obtained from the self-reported Patient Health Questionnaire-9 (PHQ-9). The baseline score will be compared to the 3-month follow-up score. The total score from this 9-item questionnaire ranges from 0 to 27, with higher scores indicating greater depression severity. Improvement is considered a decrease in the obtained score.	baseline and 3 monhts
Evaluation of clinician's impression of improvement.	Change in the score obtained from the Clinical Global Impression - Improvements questionnaire (CGI-I). The CGI-I is a 7-point scale (1= very much improved, 7= very much worse), using which the clinician assesses how much the subject's condition has improved or worsened relative to the baseline state before the treatments. Lower scores indicate greater outcomes.	baseline and 3 months
Evaluation of the self-reported impression of improvement	Change in the score obtained from the Patient Global Impression - Improvement (PGI-I). PGI-I is a 7-point scale (1= very much better, 7= very much worse), used to assess the subject's perceived change of their condition relative to the baseline state before the treatments. Lower scores indicate greater outcomes.	baseline and 3 months
Evaluation of the change in mental well-being	The change in the score obtained from the Warwick-Edinburgh Mental Well-being Scale (WEMWBS). The score ranges from 14 to 70, with higher scores indicating greater mental well-being and quality of life.	Baseline and 3 months
Evaluation of the safety of the treatment	The occurrence of adverse events will be followed throughout the whole study and evaluated.	from baseline to 3-months follow-up
Evaluation of the change in clinician-reported anxiety symptoms.	Change in the score obtained from Hamilton Anxiety Rating Scale (HAM-A). It consists of 14 items, each defined by a series of symptoms, measuring both psychic anxiety and somatic anxiety. Each item is scored from 0 (not present) to 4 (very severe), with a total score of 0 to 56. Higher scores indicate greater anxiety severity.	baseline and 3 months
Evaluation of Subject Satisfaction	Subject Satisfaction with treatment outcomes will be assessed using 5-point Likert Scale Subjects Satisfaction Questionnaire. The questionnaire will be administered after the last treatment, at the 1-month and 3-month follow-up visits. Responses to questions about satisfaction with the treatment outcomes will range from "strongly disagree" (1 point) to "strongly agree" (5 points). A higher score for each statement indicates better outcomes.	last treatment and both follow-ups
Evaluation of Therapy Comfort	Therapy Comfort questionnaire consists of two questions and will be used for evaluating the comfort and pain during the treatment sessions. The Therapy Comfort questionnaire will be administered after the last treatment. The first question "I found the treatment comfortable", to which responses are based on a 5-point Likert scale (1 = "strongly disagree", and 5 = "strongly agree"). A higher score for the statement "I found the treatment comfortable" indicates higher therapy comfort. The second question includes a 10-point Numeric Analog Scale for pain (0 = no pain, 10 = worst possible pain). Lower scores on the Numeric Analog Scale indicate lower levels of pain.	Last Treatment

Collaborators and Investigators

• Sponsor: BTL Industries Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): September 9, 2026
• Primary Completion (Estimated): April 9, 2027
• Study Completion (Estimated): April 9, 2027

Study Registration Dates

• First Submitted: September 9, 2026
• First Submitted That Met QC Criteria: September 9, 2026
• First Posted (Actual): September 15, 2026

Study Record Updates

• Last Update Posted (Actual): September 18, 2026
• Last Update Submitted That Met QC Criteria: September 15, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Generalized Anxiety Disorder
• Other Study ID Numbers: BTL-699_CTUS600

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes