Menstrual cycle effects on TMS-induced brain plasticity
Pilot Study on Menstrual Cycle-Related Hormonal Effects on Motor Cortex Plasticity Assessed by TMS in Healthy Young Adults
University of Pennsylvania · NCT07180654
This protocol will test whether menstrual cycle phase changes how the motor cortex responds to transcranial magnetic stimulation in healthy adults aged 20–40 and will compare responses between men and women.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | All |
| Sponsor | University of Pennsylvania (other) |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT07180654 on ClinicalTrials.gov |
What this trial studies
This observational pilot enrolls healthy men and women aged 20–40 and uses repeated transcranial magnetic stimulation (TMS) visits to measure motor cortex excitability and plasticity. Female participants must have regular menstrual cycles and not be taking hormonal medications; they will use take-home urine tests for estradiol/LH and complete cycle tracking in REDCap. Participants undergo four visits over about 1–2 months with blood draws and TMS procedures including motor thresholding, single-pulse, and paired-pulse protocols to quantify cortical responses. The study compares plasticity measures across menstrual time points and between sexes and correlates TMS responses with serum and urine hormone levels.
Who should consider this trial
Good fit: Healthy adults aged 20–40 who can give informed consent, with female participants having regular menstrual cycles and not using hormonal medications, are ideal candidates.
Not a fit: People with a history of seizures, epilepsy, other conditions that increase TMS risk, non-English speakers as enrolled, or those outside the age or hormonal-status criteria are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could help tailor timing or dosing of brain stimulation therapies by sex and menstrual phase to improve effectiveness and safety.
How similar studies have performed: Prior TMS research has shown that hormonal state and menstrual phase can alter cortical excitability, but findings are mixed and sex-comparative hormonal correlation data remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Nicholas Balderston, PhD — University of Pennsylvania
- Study coordinator: Nicholas Balderston, PhD
- Email: nicholas.balderston@pennmedicine.upenn.edu
- Phone: 12157463058
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cortical Activation, transcranial magnetic stimulation, cortical excitability, hormones