The Modulatory Effect of Female Sex Hormones on Spinal Neuroplasticity

NCT06656819 | Recruiting FDA Device

• 1 other identifier: STU-2020-0738
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Change in Spinal circuit excitability

  Change in Spinal circuit excitability will be assessed by measuring Hoffmann reflex/ M wave ratio of the soleus muscle. Higher scores indicate poorer outcome.

  Baseline 1, Post-60mins after peripheral nerve stimulation

• Change in Motor neuron excitability

  Changes in motor neuron excitability, as quantified by Delta-F values.

  Baseline 2, Post-60mins after priming

• Change in spinal reflex expression

  Baseline 2, Post-60mins after priming

• Change in descending drive mediated motor priming

  Baseline 2, Post-60mins after priming

Study Arms (2)

Healthy Females

Device: Magstim Rapid2

Healthy Males (control)

Device: Magstim Rapid2

Interventions

Magstim Rapid2 DEVICE

AIM 1: Investigate the estradiol effect on spinal circuit excitability post afferent (sensory) mediated subthreshold motor priming in young healthy women and men. AIM 2: Characterize the Input output property of spinal circuit excitability following descending drive (motor) mediate priming in young healthy participants AIM 3: Examine the estradiol effect on spinal circuit excitability following descending drive (motor) mediated priming in young healthy females

Healthy Females; Healthy Males (control)

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

(1) Healthy females (2) Healthy males (control)

You may qualify if:

• 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

You may not qualify if:

• 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
• Ages 18-39
• Moderately active (less than 7 hours of vigorous physical activity per week)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Study Officials

• Yasin Dhaher, Ph.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Chen Chung, PT, Ph.D.

CONTACT

214-648-8838; yu-chen.chung@utsouthwestern.edu

Subaryani Soedirdjo, Ph.D.

CONTACT

subaryani.soedirdjo@utsouthwestern.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: October 24, 2024
• Study Start: July 1, 2020
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-02

Locations

US (1)