Evaluation of the Efficacy and Safety of an Accelerated Protocol for Treating Generalized Anxiety Disorder Using the BTL-699-2 Device
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Evaluation of the change in self-reported anxiety symptoms 3 months post-treatment.
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
- •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).
研究组 & 干预措施
Treatment with BTL-699-2
Participants will receive active treatment with BTL-699-2, at an intensity of 80% of motor threshold
干预措施: EXOMIND (BTL-699-2) Active treatment (Device)
Sham Treatment with BTL-699-2
Participants will receive sham treatment with BTL-699-2, at an intensity of 5% of motor threshold
干预措施: EXOMIND (BTL-699-2) Sham treatment (Device)
结局指标
主要结局
Evaluation of the change in self-reported anxiety symptoms 3 months post-treatment.
时间窗: Baseline and 3 monhts
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.
次要结局
- 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 monhts)
- 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)
- Evaluation of Subject Satisfaction(last treatment and both follow-ups)
- Evaluation of Therapy Comfort(Last Treatment)
- Evaluation of the safety of the treatment(from baseline to 3-months follow-up)