Menstrual Cycle TMS Plasticity Pilot
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transcranial magnetic stimulation.
- Who it may be relevant to
- Registry conditions: Cortical Activation. Basic parameters: 20 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pilot Study on Menstrual Cycle-Related Hormonal Effects on Motor Cortex Plasticity Assessed by TMS in Healthy Young Adults
Overview
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.
Detailed description
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.
Interventions
- Device 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).
Primary outcome measures
- Single-pulse TMS [Time frame: 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 [Time frame: Will be collected during 3 visits over the course of a 2 month timeframe during different phases of the menstrual cycle (in females).]
Eligibility criteria
Inclusion criteria
- Able to give their consent
- If female, must have menstrual cycles of normal frequency, regularity, and duration.
Exclusion criteria
- Non-English speaking
- Any medical condition that increases risk for TMS
- History of seizure
- History of epilepsy
- Increased risk of seizure for any reason
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
United States · 1 center
- University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT07180654 · 858764