Clinical trial NCT03947684: Exploring the Modulatory Role of Sex Hormones Along the Neuromechanical Axis in Females
Official title: EMRSHN 2: Exploring the Modulatory Role of Sex Hormones Along the Neuromechanical Axis in Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Role of Sex Hormones Along the Neuromechanical Axis
Keywords: Sex Hormones
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2019-05-13
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this project is to test our central hypothesis that changes in sex hormone concentration result in changes to the basic elements of motor control - at multiple levels, from the musculotendinous unit to motor control circuitry. Under Aim 1 the investigator will determine the influence of sex hormone fluctuations on the muscle stretch reflex during active and passive states, and the time lag between hormone concentration changes and the reflex response. The investigator will use a technically simple assessment that could be implemented in the field. Under Aim 2 the investigator will determine the influence of sex hormone fluctuations on spinal motor neuron excitability using H-reflex as a probe and the simultaneous change in the muscle mechanics using muscle twitch response. Aims 1 \& 2 will include a focus on the differential role of oral contraceptives. In Aim 3 the investigator will use paired-pulse transcranial magnetic stimulation during active contraction to determine the influence of sex hormone fluctuation.


Eligibility criteria: Inclusion Criteria:

* Females: ages 18-39 years, who are eumenorrheic (regular monthly cycles of 24-35 days) or on a stable hormonal contraceptive regimen for 6 months (oral, transdermal or vaginal), no history of pregnancy, moderately active (less than 7 hours of vigorous physical activity per week)
* Males: Ages 18-39

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).
* For female participants only: Point of care screening for anemia will be completed, and individuals with hemoglobin levels \<11.6 g/dl will be excluded from participating in the study.
* Specific exclusion criteria for TMS (male and female): pacemaker, metal implants in the head region, history of epilepsy or seizures, skull fractures or skull deficits, concussion within the last 6 months, unexplained recurring headaches, medications that lower seizure threshold, and pregnancy.
* Additional exclusion criteria for female participants: History of menstrual dysfunction (primary or secondary amenorrhea, oligomenorrhea, anovulatory cycles, polycystic ovarian disease), current or past pregnancy, 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. The reason for excluding highly active or competitive athletes is due to the high rate of undiagnosed menstrual dysfunction in females of this population.
* This study will not include: adults unable to consent, Individuals who are not yet adults (infants, children, teenagers), pregnant women or prisoners.

Primary outcomes:
measure: Sex hormone fluctuations on muscle stretch reflex at relaxed and active states.
timeFrame: 2 months
measure: Tendon tap reflex testing.
timeFrame: 2 months
measure: Anterior knee laxity measurement.
timeFrame: 2 months
Secondary outcomes:
measure: H-reflex testing.
timeFrame: 2 months
measure: Polysynaptic reflex testing.
timeFrame: 2 months
Other outcomes:
measure: Sex hormone fluctuations on cortical excitability using transcranial magnetic stimulation (TMS).
timeFrame: 1 month
measure: Ovulation testing.
timeFrame: 1 month
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Yasin Dhaher, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: