Safety and Efficacy of the Combined BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Sexual Function Among Perimenopausal and Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Assessment of Change in Subjective Depressive Symptoms in Perimenopausal and Postmenopausal Women
研究概览
简要总结
The goal of this clinical trial is to evaluate if the combined treatment with EXOMIND (BTL-699-2) and EMSELLA (HPM-6000UF) devices is able to improve depressive symptoms and sexual function in women who are perimenopausal or postmenopausal without an alternative medical cause before enrollment in the study and are aged 40 years and older. The main question it aims to answer is: Does the combined treatment with EXOMIND (BTL-699-2) and EMSELLA (HPM-6000UF) devices improve depressive symptoms and urinary incontinence? Participants will be asked to:
Undergo twelve treatments Complete the Patient Health Questionnaire-9 Complete the 6-item Hamilton Depression Rating Scale Complete the Greene Climacteric Scale Complete the Therapy Comfort Questionnaire Complete the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form Complete the Female Sexual Function Index Complete the Warwick-Edinburgh Mental Wellbeing Scale Complete the Columbia Suicide Severity Rating Scale-Screen version Complete the Subject Satisfaction Questionnaire Complete the Therapy Comfort Questionnaire
详细描述
This study uses a prospective, multi-center, two-arm, single-blinded, interventional study.
The subjects will be enrolled and randomly assigned to two experimental study arms: the active group (Group A) and the sham group (Group B), in a ratio of 3:1. All enrolled participants will be treated (either active or sham) with both the BTL-699-2 and HPM-6000UF devices. Group A will receive active treatment (BTL-699-2 intensity: up to 70% of MT, HPM-6000UF intensity: up to 100%) and Group B, which receives sham treatment (BTL-699-2 intensity: 1% of MT, HPM-6000UF intensity: 1%).
The Patient Health Questionnaire-9 (PHQ-9) will be administered to the subjects before the first treatment, at every treatment visit except the first, and at the two follow-up visits-1 month and 3 months after the final session.
The 6-item Hamilton Depression Rating Scale (HAMD-6), International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), 6-item Female Sexual Function Index (FSFI-6), Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), and Columbia Suicide Severity Rating Scale-Screen version (CSSRS) will be administered to the subjects before the first treatment, after the last treatment, and at the two follow-up visits-1 month and 3 months after the final session.
The Greene Climacteric Scale (GCS) will be administered at baseline
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Menopause defined as 12 consecutive months with no menses without an alternative medical cause or perimenopause defined as occurrence of ≥ 60 days of amenorrhea without an alternative medical cause
- •Patient Health Questionnaire-9 (PHQ-9) pre-treatment score of ≥ 5
- •Age ≥ 40 years
- •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 finger
- •Subjects willing and able to abstain from partaking in any treatments other than the pre-procedure therapy regime for the improvement of depressive symptoms and/or sexual function, 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 childbearing potential* are required to use birth control measures during the whole duration of the study
- •If applicable, subjects will be maintained on pre-study psychotherapeutic regime, and prescribed chronic medications at a stable therapeutic dosage for at least 1 month prior to study entry *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.
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, implanted defibrillators, implanted neurostimulators
- •Cardiac pacemakers
- •Electronic implants
- •Metal implants
- •rTMS devices are contraindicated for use in patients who have 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
- •Application of HPM-6000UF in the head 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
- •Study specific:
- •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
- •Diagnosis of seasonal affective disorder, psychotic disorder including schizoaffective disorder or current psychotic symptoms, major depression with psychotic features, bipolar disorder
- •Substance abuse
- •Dependence 3 months prior
- •Neurological disorders, including a history of seizures, cerebrovascular disease, primary or secondary tumors in CNS, cerebral aneurysm, dementia, or movement disorders
- •History of increased intracranial pressure or head trauma
- •Ongoing intake disorders such as bulimia or anorexia, or intake disorder in the past 12 months
- •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 the 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.
研究组 & 干预措施
Active treatment with BTL-699-2 and HPM-6000UF
Participants will receive active treatment (BTL-699-2 intensity: up to 70% of MT, HPM-6000UF intensity: up to 100%)
干预措施: EXOMIND (BTL-699-2) Active Treatment (Device)
Active treatment with BTL-699-2 and HPM-6000UF
Participants will receive active treatment (BTL-699-2 intensity: up to 70% of MT, HPM-6000UF intensity: up to 100%)
干预措施: EMSELLA (HPM-6000UF) ActiveTreatment (Device)
Sham treatment with BTL-699-2 and HPM-6000UF
Participants will receive sham treatment (BTL-699-2 intensity: 1% of MT, HPM-6000UF intensity: 1%)
干预措施: EXOMIND (BTL-699-2) Sham Treatment (Device)
Sham treatment with BTL-699-2 and HPM-6000UF
Participants will receive sham treatment (BTL-699-2 intensity: 1% of MT, HPM-6000UF intensity: 1%)
干预措施: EMSELLA (HPM-6000UF) Sham Treatment (Device)
结局指标
主要结局
Assessment of Change in Subjective Depressive Symptoms in Perimenopausal and Postmenopausal Women
时间窗: 15 months
The change in the score obtained from the self-reported Patient Health Questionnaire-9 (PHQ-9). The baseline score will be compared to the 1-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.
次要结局
- Assessment of Change in Objective Symptoms of Depression in Perimenopausal and Postmenopausal Women(15 months)
- Assessment of Change in Sexual Function in Perimenopausal and Postmenopausal Women(15 months)
- Assessment of Change in Urinary Incontinence in Perimenopausal and Postmenopausal Women(15 months)
- Assessment of Change in Mental Well-Being in Perimenopausal and Postmenopausal Women(15 months)
- Assessment of Satisfaction(15 months)
- Assessment of Therapy Comfort(15 months)
- Assessment of Pain During Therapy(15 months)
- Incidence of Treatment-Related Adverse Events(15 months)