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NCT Number: NCT06656819

The Modulatory Effect of Female Sex Hormones on Spinal Neuroplasticity

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.

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Key information

Conditions

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location status: Recruiting

Location contact

Yu-Chen Chung, PT, Ph.D.

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Change in Spinal circuit excitability

    Time frame: Baseline 1, Post-60mins after peripheral nerve stimulation

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

  2. Change in Motor neuron excitability

    Time frame: Baseline 2, Post-60mins after priming

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

  3. Change in spinal reflex expression

    Time frame: Baseline 2, Post-60mins after priming

  4. Change in descending drive mediated motor priming

    Time frame: Baseline 2, Post-60mins after priming

Study contacts

Contact information is provided by the study sponsor or research team.

Subaryani Soedirdjo, Ph.D.

CONTACT

[email protected]

Yu-Chen Chung, PT, Ph.D.

CONTACT

[email protected]

214-648-8838

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Acronym: TMSpine

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Oct 24, 2024
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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