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Could a head and pelvis device combo lift menopause mood and sex life?

NCT ID NCT07413705

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

40 years and older

Sex

Female participants only

Healthy volunteers

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

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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Conditions

The condition(s) this trial relates to.

Depression physiological sexual disorder Urinary Incontinence

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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    3 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Locations

  • Aesthetic + Mind MD

    RECRUITING

    Wellesley, Massachusetts, 02481, United States

    Contact Email: •••••@•••••

  • Luxury Psychiatry Clinic

    RECRUITING

    Winter Garden, Florida, 34787, United States

  • Vitality MD Inc

    RECRUITING

    Toronto, Ontario, M5M3Y8, Canada

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