Actively Recruiting
BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Sexual Function Among Perimenopausal and Postmenopausal Women
Led by BTL Industries Ltd. · Updated on 2026-02-17
60
Participants Needed
3
Research Sites
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Sexual Function Among Perimenopausal and Postmenopausal Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 40 years or older
- Menopause defined as 12 consecutive months without menses without an alternative medical cause or perimenopause defined as 60 or more days of amenorrhea without an alternative medical cause
- Patient Health Questionnaire-9 (PHQ-9) pre-treatment score of 5 or higher
- Ability to determine motor threshold by inducing finger contraction
- Willingness to abstain from other treatments for depressive symptoms or sexual function during study participation
- Willingness to comply with study instructions and attend required visits
- Women of childbearing potential must use birth control during the study
- Stable psychotherapeutic regime and chronic medications at stable doses for at least 1 month before study entry if applicable
You will not qualify if you...
- Presence of metallic objects in or near the head, including conductive, ferromagnetic, or magnetic-sensitive metals
- Implanted devices such as stimulators, defibrillators, pacemakers, neurostimulators, or electronic implants
- Use of drug pumps
- Application of devices in the heart area or HPM-6000UF application in the head area
- History or tendency to seizures or epilepsy
- Current anticoagulation therapy
- Severe or life-threatening conditions including pulmonary insufficiency, heart disorders, and renal insufficiency
- Decompensated hemorrhagic, blood coagulation, or cardiovascular diseases
- Presence of malignant or benign tumors
- Fever or pregnancy
- Active suicidal intent or history of suicide attempts within last 3 years
- History or current use of electroconvulsive therapy or vagus nerve stimulation
- Substance-induced depression or depression due to medical condition
- Diagnosis of seasonal affective disorder, psychotic disorders, bipolar disorder, or current psychotic symptoms
- Substance abuse or dependence within past 3 months
- Neurological disorders such as cerebrovascular disease, brain tumors, cerebral aneurysm, dementia, or movement disorders
- History of increased intracranial pressure or head trauma
- Nursing
- Current or past 12 months intake disorders like bulimia or anorexia
- Any other condition posing risk or compromising the study at investigator's discretion
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Luxury Psychiatry Clinic
Winter Garden, Florida, United States, 34787
Actively Recruiting
2
Aesthetic + Mind MD
Wellesley, Massachusetts, United States, 02481
Actively Recruiting
3
Vitality MD Inc
Toronto, Ontario, Canada, M5M3Y8
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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