Generalized Anxiety Disorder (GAD)NCT07819773
Device for Treating Generalized Anxiety
A study testing EXOMIND (BTL-699-2) Active treatment in people with Generalized Anxiety Disorder (GAD), run by BTL Industries Ltd. at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Generalized Anxiety Disorder (GAD)
- What is being tested?
- EXOMIND (BTL-699-2) Active treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Sep 2026to 9 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 33Show fewer
- 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).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
The Study by AC
Chicago, Illinois, 60611
Charmi Patel, MD, (312) 883-6843, charmi@astraculture.com
- Recruiting
Aria Integrative Health
Denver, Colorado, 80211
Henry Johnston III, MD, (720) 358-0725, drjjohnston3md@gmail.com
- Recruiting
Cady Wellness Institute
Newburgh, Indiana, 47630
Louis Cady, MD, (812) 429-0772, lbcady@cadywellness.com
About this study
Official title: 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.
Read more
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)
- Being tested
- EXOMIND (BTL-699-2) Active treatment, EXOMIND (BTL-699-2) Sham treatment
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXOMIND (BTL-699-2) Active treatmentDevice
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 treatmentDevice
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 group | Role | What they receive |
|---|---|---|
| Treatment with BTL-699-2 | Experimental | Participants will receive active treatment with BTL-699-2, at an intensity of 80% of motor threshold Receives: 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 Receives: Device: EXOMIND (BTL-699-2) Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3 months
Secondary outcomes (8)
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.
Measured: baseline and 3 monhts
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.
Measured: baseline and 3 months
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Last Treatment
Evaluation of the safety of the treatment
The occurrence of adverse events will be followed throughout the whole study and evaluated.
Measured: from baseline to 3-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start9 Sep 2026 (estimated)
- Primary completion9 Apr 2027 (estimated)
- Study completion9 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety Disorder (GAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BTL Industries Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819773
- Sponsor's protocol ID
- BTL-699_CTUS600
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of an Accelerated Protocol for Treating Generalized Anxiety Disorder Using the BTL-699-2 Device
- ClinicalTrials.gov ID
- NCT07819773
- Acronym / sponsor ID
- BTL-699_CTUS600
- Conditions
- Generalized Anxiety Disorder (GAD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2026 (estimated)
- Primary completion
- 9 Apr 2027 (estimated)
- Study completion
- 9 Apr 2027 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with BTL-699-2 | Experimental | Device: EXOMIND (BTL-699-2) Active treatmentParticipants will receive active treatment with BTL-699-2, at an intensity of 80% of motor threshold |
| Sham Treatment with BTL-699-2 | Sham comparator | Device: EXOMIND (BTL-699-2) Sham treatmentParticipants will receive sham treatment with BTL-699-2, at an intensity of 5% of motor threshold |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (33 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXOMIND (BTL-699-2) Active treatmentParticipants 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. | Device | Treatment with BTL-699-2 |
| EXOMIND (BTL-699-2) Sham treatmentParticipants 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. | Device | Sham Treatment with BTL-699-2 |
Primary outcome
Evaluation of the change in self-reported anxiety symptoms 3 months post-treatment.
Time frame: Baseline and 3 months
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.
8 secondary outcomes
Evaluation of the change in self-reported depressive symptoms.
Time frame: baseline and 3 monhts
Evaluation of the change in clinician-reported anxiety symptoms.
Time frame: baseline and 3 months
Evaluation of clinician's impression of improvement.
Time frame: baseline and 3 months
Evaluation of the self-reported impression of improvement
Time frame: baseline and 3 months
Evaluation of the change in mental well-being
Time frame: Baseline and 3 months
Evaluation of Subject Satisfaction
Time frame: last treatment and both follow-ups
Evaluation of Therapy Comfort
Time frame: Last Treatment
Evaluation of the safety of the treatment
Time frame: from baseline to 3-months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXOMIND (BTL-699-2) Active treatment in people with Generalized Anxiety Disorder (GAD), run by BTL Industries Ltd. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the change in self-reported anxiety symptoms 3 months post-treatment. (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.