BridgeMD
New treatment option for Depressive Symptoms
Official title BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Sexual Function Among Perimenopausal and Postmenopausal Women
ClinicalTrials.gov ID: NCT07413705
What this study is testing
- What it's testing
- 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?
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older, women only
You may be able to join if
- Menopause defined as 12 consecutive months with no menses without an alternative medical cause or perimenopause defined as occurrence of ≥ 60 days of...
- 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...
- people willing and able to abstain from partaking in any treatments other than the pre-procedure therapy regime for the improvement of depressive...
You likely can't join if
- 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...
- Implanted stimulator devices, implanted defibrillators, implanted neurostimulators
- Cardiac pacemakers
- Electronic implants
- Metal implants
See the full eligibility 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
- people 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...
- 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, people 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...
- 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. -...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Winter Garden, Florida, United States
- Wellesley, Massachusetts, United States
- Toronto, Ontario, Canada
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Winter Garden, Florida, United States; Wellesley, Massachusetts, United States; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.