NCT07180654 · University of Pennsylvania
Menstrual Cycle TMS Plasticity Pilot
What this study is about
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.
View original scientific description
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.
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).
Single-pulse TMS: Cortical excitability curves will be measured before and after a single 1800-pulse train of iTBS. Motor Evoked Potentials (MEPs) will be recorded from the right FDI muscle at 7 distinct intensities ranging from -20% to + 40% of MT. Single pulses will be delivered once every 10±3 seconds to the left motor cortex at random intensities in the above range to avoid habituation across pulses. Across the session, a total of 70 pulses will be delivered before and after iTBS, 10 at each intensity.
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).
Paired-pulse stimulation: Subjects will undergo paired-pulse stimulation to measure both intracortical inhibition and intracortical facilitation. For intracortical inhibition, subjects will receive a conditioning pulse at 80% MT 4 seconds before the test pulse at 120% MT. For intracortical facilitation, subjects will receive a conditioning pulse at 120% MT 15s before the test pulse at 120% MT. Across the session, a total of 60 paired pulses will be delivered before and after iTBS, 30 at each ISI.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Philadelphia, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 9, 2026 · Source of record for eligibility and locations