Wellesley, MANCT07413705Now EnrollingIRB Ready

Depressive Symptoms Clinical Trial in Wellesley, MA

Access cutting-edge depressive symptoms treatment through this clinical trial at a research site in Wellesley. Study-provided care at no cost to qualified participants.

Sponsored by BTL Industries Ltd.

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Expert Care in Wellesley

Access depressive symptoms specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related depressive symptoms treatment provided free

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Check if you qualify for this depressive symptoms clinical trial in Wellesley, MA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Wellesley

    Convenient for MA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Wellesley site if eligible
  4. 4Begin participation

About This Depressive Symptoms Study in Wellesley

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? Participants will be asked to: Undergo twelve treatments Complete the Patient Health Questionnaire-9 Complete the 6-item Hamilton Depression Rating Scale Complete the Greene Climacteric Scale Complete the Therapy Comfort Questionnaire Complete the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form Complete the Female Sexual Function Index Complete the Warwick-Edinburgh Mental Wellbeing Scale Complete the Columbia Suicide Severity Rating Scale-Screen version Complete the Subject Satisfaction Questionnaire Complete the Therapy Comfort Questionnaire

Sponsor: BTL Industries Ltd.

Who Can Participate

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.
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
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
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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Wellesley?

Yes, this clinical trial (NCT07413705) has an active research site in Wellesley, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Depressive Symptoms Treatment Options in Wellesley, MA

If you're searching for depressive symptoms treatment options in Wellesley, MA, this clinical trial (NCT07413705) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Wellesley research site is actively enrolling participants for this clinical trial. You'll receive care from experienced depressive symptoms specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all depressive symptoms clinical trials near you to find additional studies recruiting in your area.

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