NCT06656819 The Modulatory Effect of Female Sex Hormones on Spinal Neuroplasticity
| NCT ID | NCT06656819 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Healthy |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2020-07-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2020-07-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this project is to test our central hypothesis that the spinal cord neuroplasticity in females will be modulated by the level of estradiol concentration. under aim 1 we will determine the influence of estradiol fluctuations on spinal circuit excitability post afferent (sensory) mediated subthreshold motor priming in young healthy females and males. We will use an established repetitive peripheral nerve electrical stimulation with a stimulation intensity below the motor threshold to prime the spinal motor circuits. under aim 2 we seek to characterize the input output property of spinal circuit excitability after descending drive (motor) mediated priming in young healthy male participants. in aim 3 we will examine the influence of estradiol fluctuations on descending drive mediated motor priming in young healthy females.
Eligibility Criteria
FEMALES Inclusion Criteria: * Ages 18-39 years * Eumenorrheic (regular monthly cycles of 24-35 days) * Moderately active (less than 7 hours of vigorous physical activity per week) * History of pregnancy is allowed if patient is in post-lactation phase Exclusion Criteria: * History of musculoskeletal or orthopedic injury of the spine, hip, knee, ankle or foot * History of neurological injury of the peripheral or central nervous system * Current smoker * History of disordered eating * History of stress fracture in the lower limb * History of a connective tissue disorder (Marfan's syndrome, Ehlers-Danlos disease) * Pacemaker, metal implants in the head and spine region * Pregnancy * On a hormonal contraceptive regimen (oral, transdermal or vaginal) * History of menstrual dysfunction (primary or secondary amenorrhea, oligomenorrhea, anovulatory cycles, polycystic ovarian disease) * Started or stopped taking oral contraceptives within the previous 6 months * Exercise vigorously more than 7 hours per week or currently participating in competitive level sports. MALES Inclusion Criteria: * Ages 18-39 * Moderately active (less than 7 hours of vigorous physical activity per week) Exclusion Criteria: * History of musculoskeletal or orthopedic injury of the spine, hip, knee, ankle or foot * History of neurological injury of the peripheral or central nervous system * Current smoker * History of disordered eating * History of stress fracture in the lower limb * History of a connective tissue disorder (Marfan's syndrome, Ehlers-Danlos disease) * Pacemaker, metal implants in the head and spine region
Contact & Investigator
Yasin Dhaher, Ph.D.
PRINCIPAL INVESTIGATOR
University of Texas Southwestern Medical Center
Frequently Asked Questions
Who can join the NCT06656819 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 39 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06656819 currently recruiting?
Yes, NCT06656819 is actively recruiting participants. Contact the research team at yu-chen.chung@utsouthwestern.edu for enrollment information.
Where is the NCT06656819 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT06656819 clinical trial?
NCT06656819 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is Yasin Dhaher, Ph.D. at University of Texas Southwestern Medical Center. The trial plans to enroll 50 participants.