Device for Treating Generalized Anxiety
ConditionGeneralized Anxiety Disorder (GAD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorBTL Industries Ltd.
About 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
EXOMIND (BTL-699-2) Active treatment
DeviceParticipants 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 treatment
DeviceParticipants 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Treatment with BTL-699-2Experimental treatment 1 intervention
Group B: Sham Treatment with BTL-699-2Sham comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline and 3 monthsSecondary outcomes
1
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 monhts2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov