Effects of female hormones on spinal cord function

TMSpine: The Modulatory Effect of Female Sex Hormones on Spinal Neuroplasticity

This study is testing how changes in female hormones affect the spinal cord's ability to adapt and function in healthy young women and comparing it with men.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years to 39 Years
• Sex: All
• Sponsor: University of Texas Southwestern Medical Center (Academic / other)
• Locations: 1 site (Dallas, Texas)
• Trial ID: NCT06656819 on ClinicalTrials.gov

What this trial studies

This project aims to investigate how fluctuations in estradiol levels affect spinal cord neuroplasticity in healthy young females. The study will assess spinal circuit excitability through sensory and motor priming techniques, utilizing repetitive peripheral nerve electrical stimulation. It will involve both male and female participants to compare the effects of hormonal variations on spinal motor circuits. The research seeks to enhance understanding of the role of female sex hormones in spinal cord function.

Who should consider this trial

Good fit: Ideal candidates are healthy females aged 18-39 with regular menstrual cycles and moderate physical activity levels.

Not a fit: Patients with a history of spinal or neurological injuries, hormonal contraceptive use, or certain medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatments for conditions related to spinal cord function and neuroplasticity in women.

How similar studies have performed: While the specific approach may be novel, studies on the effects of sex hormones on neuroplasticity have shown promising results.

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

Where this trial is running

Dallas, Texas

• University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Yasin Dhaher, Ph.D. — University of Texas Southwestern Medical Center
• Study coordinator: Yu-Chen Chung, PT, Ph.D.

Conditions Healthy