An interventional study of EXOMIND (BTL-699-2) Active treatment and EXOMIND (BTL-699-2) Sham treatment in Generalized Anxiety Disorder (GAD), sponsored by BTL Industries Ltd.. Recruiting at 3 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by BTL Industries Ltd. · Not applicable, Interventional, and Treatment
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:
517 studies on the registry are indexed under Generalized Anxiety Disorder; 124 are open to participants now.
This study's planned enrollment of 40 is below the median of 83 across 439 interventional studies indexed under Generalized Anxiety Disorder.
Browse Generalized Anxiety Disorder studies →BTL Industries Ltd. is the lead sponsor of 77 studies on the registry; 5 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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 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.
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.
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.
Time frame: Baseline and 3 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Last Treatment
Evaluation of the safety of the treatment
The occurrence of adverse events will be followed throughout the whole study and evaluated.
Time frame: from baseline to 3-months follow-up
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Apr 2027, 7 months later.
Of 183 interventional studies with no phase under Generalized Anxiety Disorder, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's planned 7 months is below that.
How these figures are worked out, and which studies are left out of them.
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Generalized Anxiety Disorder →