Actively Recruiting
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
Led by BTL Industries Ltd. · Updated on 2026-02-17
60
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether the combined use of the EXOMIND (BTL-699-2) and EMSELLA (HPM-6000UF) devices can improve depressive symptoms, sexual function, and urinary incontinence in women who are perimenopausal or postmenopausal, aged 40 years and older, without other medical causes. The study uses a prospective, multi-center, randomized, single-blinded design with two groups to assess safety and efficacy over approximately five months. Participants are randomly assigned in a 3:1 ratio to either an active treatment group or a sham treatment group. The active group receives six sessions of transcranial magnetic stimulation using the BTL-699-2 device over the left dorsolateral prefrontal cortex at intensities up to 70% of their motor threshold, and six treatments with the HPM-6000UF device applied to pelvic floor muscles at intensities up to 100%. The sham group receives similar procedures at minimal intensities (1%). Treatments are spaced 3 to 7 days apart. During the study, participants complete several assessments including the Patient Health Questionnaire-9, Hamilton Depression Rating Scale, Greene Climacteric Scale, International Consultation on Incontinence Questionnaire, Female Sexual Function Index, Warwick-Edinburgh Mental Wellbeing Scale, Columbia Suicide Severity Rating Scale, Therapy Comfort Questionnaire, and Subject Satisfaction Questionnaire. These are completed at baseline, during treatment, and at follow-ups 1 month and 3 months post-treatment. Researchers monitor changes in depressive symptoms, sexual function, urinary incontinence, mental well-being, therapy comfort, satisfaction, and any treatment-related adverse events.
CONDITIONS
Brief 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...
- Menopause defined as 12 consecutive months with no menses without an alternative medical cause or perimenopause defined as at least 60 days of amenorrhea without an alternative medical cause
- Patient Health Questionnaire-9 (PHQ-9) pre-treatment score of 5 or higher
- Age 40 years or older
- Ability to determine the motor threshold by inducing finger contraction
- Willingness to avoid other treatments for depressive symptoms or sexual function during the study
- Willingness to follow study instructions and attend required visits
- Women of childbearing potential must use birth control throughout the study
- Stable psychotherapeutic regime and medications for at least 1 month before study entry, if applicable
You will not qualify if you...
- Presence of metallic objects or magnetic-sensitive metals in or near the head
- Implanted stimulators, defibrillators, pacemakers, electronic implants, or metal implants
- Devices contraindicated for rTMS such as deep brain stimulators or cochlear implants
- Drug pumps or application of devices in the head or heart area
- History or tendency to seizures, epilepsy, or certain neurological disorders
- Anticoagulation therapy
- Severe or life-threatening conditions including pulmonary, heart, or renal insufficiency
- Decompensated hemorrhagic, blood coagulation, or cardiovascular diseases
- Malignant or benign tumors
- Fever, pregnancy, or nursing
- Active suicidal intent or recent suicide attempts
- Use or history of electroconvulsive therapy or vagus nerve stimulation
- Substance abuse or dependence within 3 months
- Diagnosis of psychotic disorders, bipolar disorder, or seasonal affective disorder
- Eating disorders currently or within the past 12 months
- Any other condition posing risk or compromising study participation as determined by the investigator
- Certain metal implants in the mouth allowed except those posing serious risk
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 to 6 weeks
Participants receive six treatments with both the BTL-699-2 and HPM-6000UF devices, either active or sham, spaced 3 to 7 days apart.
6 treatment visits
Duration - 3 months
Participants are assessed at 1 month and 3 months after the final treatment to monitor depressive symptoms, sexual function, urinary incontinence, mental well-being, therapy comfort, and satisfaction.
2 follow-up visits
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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