Study of EXOMIND and EMSELLA for Depressive Symptoms and Sexual Function in Menopausal Women
This study is looking at whether combining two devices, EXOMIND (BTL-699-2) and EMSELLA (HPM-6000UF), can help improve depressive symptoms, urinary incontinence, and sexual function in women who are going through perimenopause or have already gone through menopause. You can join if you are a woman aged 40 or older, have experienced at least 60 days without a period (perimenopause) or 12 consecutive months without a period (menopause), and have a certain score on a depression questionnaire (PHQ-9 score of 5 or higher). The main goal is to see how much your depressive symptoms change over 15 months. The study is currently unclear on its recruitment status.
- Study design
- This study is a prospective, multi-center, two-arm, single-blinded, interventional study. About 60 participants will be randomly assigned to either an active treatment group or a sham (inactive) treatment group.
- What's involved
- You would undergo twelve treatments with both devices. You will also complete several questionnaires before, during, and after your treatments.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your depressive symptoms will be assessed for 15 months after the study begins. Other assessments will occur 1 month and 3 months after your final treatment session.
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NCT07413705
BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Sexual Function Among Perimenopausal and Postmenopausal Women
Recruiting
NAAges 40+InterventionalTreatmentBTL Industries Ltd.
~60 participants
Updated 2026-02-17 on ClinicalTrials.gov
What's tested:EXOMIND (BTL-699-2) Active TreatmentEMSELLA (HPM-6000UF) ActiveTreatmentEXOMIND (BTL-699-2) Sham TreatmentEMSELLA (HPM-6000UF) Sham Treatment
At a glance
Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assessment of Change in Subjective Depressive Symptoms in Perimenopausal and Postmenopausal Women
Measured over 15 months
Conditions
Where it's being run
3 sites across 3 statesFlorida1
Massachusetts1
Ontario1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
Exclusion
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
Fever
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
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
Nursing
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.
What this trial measures
- Assessment of Change in Subjective Depressive Symptoms in Perimenopausal and Postmenopausal Women15 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.