Menstrual Cycle TMS Plasticity Pilot
ConditionCortical Activation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-40
SponsorUniversity of Pennsylvania
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Able to give their consent
If female, must have menstrual cycles of normal frequency, regularity, and duration.
Disqualifiers
Non-English speaking
Any medical condition that increases risk for TMS
History of seizure
History of epilepsy
Trial population
Participants will be recruited from the community in the Philadelphia Metro Area.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
transcranial magnetic stimulation
DeviceSubjects 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).
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Volunteers1 intervention
Trial outcomes
Primary outcomes
1
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.
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).2
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.
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).Sponsors and contacts
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Source ClinicalTrials.gov