Menstrual Cycle TMS Plasticity Pilot

Официальное название

Pilot Study on Menstrual Cycle-Related Hormonal Effects on Motor Cortex Plasticity Assessed by TMS in Healthy Young Adults

Обзор

Aim 1: Assess how menstrual cycle phase affects motor cortex plasticity in females. Aim 2: Compare motor cortex plasticity between males and females across the same time points, identifying potential sex differences in TMS response. Aim 3: Examine associations between serum hormone levels and TMS-induced plasticity within and between sexes.

Подробное описание

This project will recruit healthy male and female volunteers between the ages of 20-40. Females must who are not on hormonal medications and, if female, have regular menstrual cycles as defined in Table 1. At time of consent, female participants will be send home with given tests that may assess urine estradiol, LH and/or their metabolites. Participants will be asked to complete these tests at home, will be instructed to use these tests in the morning at the first void of the day; the number of days during each cycle that participants will be asked to complete these tests will be based on their report of their regular cycle pattern but will not be longer than half the number of days in each cycle. In addition, female subjects will be given a RedCap survey link at which they will track their menstrual cycle and results from the urine estradiol/LH tests.

Subjects will undergo 4 study visits over approximately 1-2 months depending on availability and, if female, menstrual cycle point. At visit 1, subjects will consent to the protocol, fill out surveys including the TMS Adult Safety Screening (TASS) and a questionnaire about past hormonal medication use and if relevant, menstrual cycle history. If female, subjects will be given take-home ovulation tests to use across the study duration.

On the following visits, they may undergo the following procedures: 1) venipuncture to collect approximately 45mL 10 mL of blood 2) motor threshold testing, 2) Paired-Pulse Stimulation 3) Single-Pulse TMS to the motor cortex 4) intermittent Theta Burst Stimulation (iTBS) to the motor cortex.

Вмешательства

• Устройство transcranial magnetic stimulation
  Subjects will receive a series of 60 10s trains that will be presented over the course of the \~3.5 min session. Each train will consist of 2 s of stimulation with an 8 s ITI. During the 2 s of stimulation, 10, 50 Hz bursts will be repeated at intervals of 200 ms (5 Hz). iTBS will be administered at 100% of the motor threshold (MT).

Первичные конечные точки

• Single-pulse TMS [Срок оценки: Will be collected during 3 visits over the course of a 2 month timeframe during different phases of the menstrual cycle (in females).]
• Paired pulse stimulation [Срок оценки: Will be collected during 3 visits over the course of a 2 month timeframe during different phases of the menstrual cycle (in females).]

Критерии участия

Критерии включения

• Able to give their consent
• If female, must have menstrual cycles of normal frequency, regularity, and duration.

Критерии исключения

• Non-English speaking
• Any medical condition that increases risk for TMS
• History of seizure
• History of epilepsy
• Increased risk of seizure for any reason

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

США · 1 центр

• University of Pennsylvania — Philadelphia

Идентификаторы

NCT: NCT07180654 · 858764

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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