Could a head and pelvis device combo lift menopause mood and sex life?
NCT ID NCT07413705
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether two devices used together can help perimenopausal and postmenopausal women with depression and sexual issues. One device delivers magnetic pulses to the brain (EXOMIND), and the other stimulates the pelvic floor muscles (EMSELLA). Sixty women aged 40 and older will receive six sessions of each treatment and be followed for one month to see if their symptoms improve.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- EXOMIND (transcranial magnetic stimulation device) and EMSELLA (pelvic floor electromagnetic stimulation device)
- What this could lead to
- If it works, this could offer a non-drug option to improve mood and sexual function in women going through menopause.
- What could go wrong
- This is a small, early-stage study with only 60 participants and no control group, so results may not be conclusive. The devices are not yet proven for these symptoms.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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 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 * 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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
3 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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Aesthetic + Mind MD
RECRUITINGWellesley, Massachusetts, 02481, United States
Contact Email: •••••@•••••
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Luxury Psychiatry Clinic
RECRUITINGWinter Garden, Florida, 34787, United States
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Vitality MD Inc
RECRUITINGToronto, Ontario, M5M3Y8, Canada
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