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Набор скоро начнётся NCT07375732

Transcranial Electrical Stimulation for Noninvasive Study of Menopausal/Perimenopausal Symptoms

Без фазы С лечением Menopausal Depression Menopause Hot Flashes Menopause Menopause Related Conditions

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Transcranial Electrical Stimulation.
Кому может быть актуально
Состояния в реестре: Menopausal Depression, Menopause Hot Flashes, Menopause, Menopause Related Conditions. Базовые параметры: 40 лет — 60 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Participants are being invited to a research study. This research aims to assess the tolerability of transcranial electrical stimulation of the brain, and explore the response of TES on menopausal/perimenopausal symptoms including hot flashes effects, depression/anxiety, memory-problems, and muscular problems. This study will assess what types of electrical brain stimulation affect different menopausal related symptoms. This study will help guide the development of electrical stimulation to be used for improving women's health during menopause transition.

Подробное описание

The purpose of this study is to assess the tolerability of transcranial electrical stimulation of the brain, and explore the response of TES on menopausal/perimenopausal symptoms including vasomotor effects , depression/anxiety, memory-problems. Electrical stimulation comprises a pattern of electrical currents that are delivered into the skin non-invasively using an array of electrodes adhered to the skin surface. Pain administration and sensory testing may be performed using thermodes, which are devices attached to limbs whose temperature is controlled using a computer (heat and cold pain). Temperature will be varied across time and heat/cold delivered to assess any changes in self-reported pain and/or non-invasive Electroencephalography (EEG) and functional Near-Infrared Spectroscopy (fNIRS). Examining the association of locations of current delivery with changes in self-reported pain and EEG/fNIRS recordings will help assess the spatiotemporal dynamics in the brain relevant to pain perception and the nature of their effects on pain (e.g. increase or decrease). Prior to testing the effects on pain, the individual's primary motor cortex may be localized by delivering short pulses at locations close to the motor cortex and measuring muscle responses using electromyography (EMG) electrodes placed on muscles (e.g. on the arms and legs).

The participant's resting state and pain-evoked brain activity will also be recorded using non-invasive Electroencephalography (EEG) and functional Near-Infrared Spectroscopy (fNIRS).

The stimulation techniques - called SharpFocus Transcranial Electrical Stimulation (SharpFocus TES) - consist of patch arrays (a set of electrodes arranged in a grid and embedded in a flexible substrate that conforms to the skin surface) or individual electrodes being installed at various locations including the head, arms, and legs. Some of the electrodes on the scalp inject current for brain stimulation. The rest of the electrodes are for recording. Conductive cream, gel, or hydrogel is placed between the electrode and skin to improve adhesion and conductivity. Additionally, or alternatively, classic cup (e.g. gold-cup) electrodes (10 mm diameter or 6 mm diameter), used routinely in the clinic, might also be used, especially for participants with thick or long hair. A multichannel electrical stimulator connects to the electrode array to deliver pulses of electrical current that are varied in timing, intensity, and location to allow fine-grained control of the site(s) of stimulation in the brain.

For sensory effects, participants will be asked to report any modulation of pain sensation they feel on electrical stimulation. Experiments will be performed to measure effects on muscle activity and perceived sensations.

Results from these experiments will be used to verify and refine computational models that have been developed to simulate biophysical effects of SharpFocus TES. Furthermore, it will aid in the understanding of how the central nervous system affects several of the symptoms seen in menopause/perimenopause. The ultimate goal of this research is to create a wearable interface that can stimulate parts of the cortex for a variety of applications pertaining to menopause/perimenopause.

Вмешательства

  • Устройство Transcranial Electrical Stimulation
    SharpFocus transcranial electrical stimulation (TES) uses a multichannel stimulator connected to a scalp electrode to deliver precisely timed, intensity-modulated electrical pulses. By varying the timing, amplitude, and location of these pulses, the system achieves focal stimulation of targeted cortical regions. Investigators will use Digitimer DS8R and/or Digitimer DS5 current stimulators to apply all current stimuli. These stimulators are CE certified and are intended for use in human researc

Первичные конечные точки

  • Depression [Срок оценки: From enrollment to the end of treatment at 22 days]
  • Sleep Quality [Срок оценки: Study enrollment to end of study at 22 days]
  • Menopause Quality of Life [Срок оценки: Upon enrollment to 22 days]
  • Center for Epidemiological Studies-Depression Inventory (CES-D) [Срок оценки: Upon enrollment to 22 days]
  • Numerical Rating Scale [Срок оценки: Upon enrollment to 22 days]
Вторичные конечные точки (9)
  • Pain Catastrophizing Scale [Срок оценки: Upon enrollment to 22 days]
  • Impulsive Behavior Scale [Срок оценки: Upon enrollment to 22 days]
  • Brief Pain Inventory [Срок оценки: Upon enrollment to 22 days.]
  • Electromyography Recording [Срок оценки: Upon enrollment to 22 days]
  • Sternal Skin Conductance [Срок оценки: Upon enrollment to 22 days]
  • Functional Near-Infrared Spectroscopy [Срок оценки: Upon enrollment to 22 days]
  • Electroencephalogram [Срок оценки: Upon enrollment to 22 days]
  • Heat Pain Thresholding [Срок оценки: Upon enrollment to 22 days]
  • Pressure Pain Thresholding [Срок оценки: Upon enrollment to 22 days]

Критерии участия

Критерии включения

  • Age between 40 and 60 years
  • Participants falling under stages -2 to +2 in the Stages of Reproductive Aging Workshop (STRAW +10) as defined below:
  • Early menopause transition (Stage -2): Increased variability in menstrual cycle defined as persistent difference of 7 days or more in the length of consecutive cycles. Persistence is defined as recurrence within 10 cycles of the first variable cycle.
  • Late menopause transition (Stage -1): Occurrence of amenorrhea of 60 days or longer.
  • Final Menstrual Period (Stage 0): Have undergone 12 consecutive months without a menstrual period, not due to other medical causes.
  • Early Postmenopause (Stage +1): 5-8 years after final menstrual period.
  • Late Postmenopause (Stage +2): >8 years after final menstrual period.
  • Participants having frequent hot flashes (at least once a day).

Критерии исключения

  • Disorders that may mask or coincide with menopause and peri-menopause, such as: Primary Ovarian Insufficiency, Thyroid disease (Hyper/hypothyroidism), Hyperprolactinemia, Cushing's syndrome, Endometrial/Ovarian Cancer, Polycystic Ovary Syndrome (PCOS), Functional hypothalamic amenorrhea
  • Concurrent drugs:
  • GnRH agonist/antagonist
  • Tamoxifen/aromatase inhibitors
  • Other conditions: Recent hematoma (<48 hours), History of hemorrhagic disorders (any platelet disorder (ITP, TTP, HUS, Glanzmann thrombasthenia), Hemophilia A/B, history of arterial insufficiency, any prior history of malignancy, current pregnancy, a lifetime history of severe, uncontrolled mood disorders (anxiety, depression, bipolar), psychotic disorders, other neural disorders, or heart disease, any condition that makes them unable to perform tasks outlined in experiment, tattoos on sensory testing sites.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Оценка устройства

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07375732 · STUDY2025_00000313

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗