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The Modulatory Effect of Female Sex Hormones on Spinal Neuroplasticity

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06656819
Acronym
TMSpine
Enrollment
50
Registered
2024-10-24
Start date
2020-07-01
Completion date
2027-12-31
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

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

Sponsors

University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
Yes

Inclusion 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)

Design outcomes

Primary

MeasureTime frameDescription
Change in Spinal circuit excitabilityBaseline 1, Post-60mins after peripheral nerve stimulationChange in Spinal circuit excitability will be assessed by measuring Hoffmann reflex/ M wave ratio of the soleus muscle. Higher scores indicate poorer outcome.
Change in Motor neuron excitabilityBaseline 2, Post-60mins after primingChanges in motor neuron excitability, as quantified by Delta-F values.
Change in spinal reflex expressionBaseline 2, Post-60mins after priming
Change in descending drive mediated motor primingBaseline 2, Post-60mins after priming

Countries

United States

Contacts

CONTACTYu-Chen Chung, PT, Ph.D.
yu-chen.chung@utsouthwestern.edu214-648-8838
CONTACTSubaryani Soedirdjo, Ph.D.
subaryani.soedirdjo@utsouthwestern.edu
PRINCIPAL_INVESTIGATORYasin Dhaher, Ph.D.

University of Texas Southwestern Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026