Cortical ActivationNCT07180654
Menstrual Cycle TMS Plasticity Pilot
An observational study of Cortical Activation, run by University of Pennsylvania at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cortical Activation
- What is being tested?
- transcranial magnetic stimulation
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to 31 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants will be recruited from the community in the Philadelphia Metro Area.
Who may be able to join
- Able to give their consent
- If female, must have menstrual cycles of normal frequency, regularity, and duration.
Who cannot join
- Non-English speaking
- Any medical condition that increases risk for TMS
- History of seizure
- History of epilepsy
- Increased risk of seizure for any reason
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Nicholas l Balderston, PhD, 215-746-3058, nicholas.balderston@pennmedicine.upenn.edu
About this study
Official title: Pilot Study on Menstrual Cycle-Related Hormonal Effects on Motor Cortex Plasticity Assessed by TMS in Healthy Young Adults
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.
Read the 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.
- Conditions
- Cortical Activation
- Being tested
- transcranial magnetic stimulation
- Keywords
- transcranial magnetic stimulation, cortical excitability, hormones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial magnetic stimulationDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Volunteers | Single group design Receives: Device: transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single-pulse TMS
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.
Measured: 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
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.
Measured: Will be collected during 3 visits over the course of a 2 month timeframe during different phases of the menstrual cycle (in females).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start15 Dec 2025
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cortical ActivationStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Balderston, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180654
- Sponsor's protocol ID
- 858764
- Status last verified
- Jan 2026
- First submitted
- 2 Sep 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Menstrual Cycle-Related Hormonal Effects on Motor Cortex Plasticity Assessed by TMS in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT07180654
- Acronym / sponsor ID
- 858764
- Conditions
- Cortical Activation
- Keywords
- transcranial magnetic stimulation, cortical excitability, hormones
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volunteers | – | Device: transcranial magnetic stimulationSingle group design |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants will be recruited from the community in the Philadelphia Metro Area.
Key inclusion criteria (2 listed)
- Able to give their consent
- If female, must have menstrual cycles of normal frequency, regularity, and duration.
Key exclusion criteria (5 listed)
- Non-English speaking
- Any medical condition that increases risk for TMS
- History of seizure
- History of epilepsy
- Increased risk of seizure for any reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial magnetic stimulationSubjects 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). | Device | Volunteers |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Cortical Activation
Recruiting
The Influence of 3D Printed Prostheses on Neural Activation Patterns
Amniotic Band Syndrome, Upper Extremity Deformities, Congenital
RecruitingObservational study
LAnguage-Motor Imagery Circuits to Improve Motor Learning and Language Comprehension
Corticospinal Excitability, Cortical Activation
Active, not recruiting
Effects of Park Golf on Working Memory and Prefrontal Cortex Activation in Older Adults
Cognitive Function, Working Memory
RecruitingObservational study
Cerebral Palsy and the Study of Brain Activity During Motor Tasks
Cerebral Palsy, Children
Not yet recruiting
Cardiorespiratory Fitness and Acute High-Intensity Exercise Effects on Brain and Cognitive Function in Older Adults
Healthy Aging, Cognitive Benefits
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicholas Balderston, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cortical Activation, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicholas Balderston, PhD (12157463058, nicholas.balderston@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.