Exploring the Modulatory Role of Sex Hormones Along the Neuromechanical Axis in Females (EMRSHN)
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|ClinicalTrials.gov Identifier: NCT03947684|
Recruitment Status : Recruiting
First Posted : May 13, 2019
Last Update Posted : May 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Role of Sex Hormones Along the Neuromechanical Axis||Device: Transcranial Magnetic Stimulation Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||EMRSHN 2: Exploring the Modulatory Role of Sex Hormones Along the Neuromechanical Axis in Females|
|Actual Study Start Date :||April 12, 2019|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||April 2022|
Paired-pulse transcranial magnetic stimulation during active contraction to determine the influence of sex hormone fluctuations on cortical excitability in naturally cycling women.
Device: Transcranial Magnetic Stimulation Device
The TMS device electrically stimulates the intended parts of the brain. In this study, the investigator plan to target the part of the brain cortex that is responsible for the voluntary motion of the leg muscles, whose functions are under investigation.
- Sex hormone fluctuations on muscle stretch reflex at relaxed and active states. [ Time Frame: 2 months ]Blood draw for Estradiol, Progesterone, and Testosterone.
- Tendon tap reflex testing. [ Time Frame: 2 months ]The muscle reflex will be evoked by tapping the patellar tendon with a hammer instrumented with a load cell. The load cell instrumented hammer will allow us to quantify the reflex gain by normalizing the reflex EMG by the tap force.
- Anterior knee laxity measurement. [ Time Frame: 2 months ]To assess the joint's connective tissue response at varying points in the cycle, anterior knee laxity (AKL) will be measured with the knee arthrometer.
- H-reflex testing. [ Time Frame: 2 months ]For the monosynaptic H-reflex testing, a stimulating bar bipolar electrode will be placed over the tibial nerve in the popliteal fossa with the anode positioned distally. The H-reflex and M-Wave will be recorded from the soleus muscle using surface EMG electrodes placed over the muscle belly at the myotendinous junction.
- Polysynaptic reflex testing. [ Time Frame: 2 months ]For polysynaptic reflex testing, stimulation will be applied behind the medial malleolus of the ankle to the distal tibial nerve using a Grass Instruments S48 Stimulator, a Grass SIU5 Stimulus Isolation Unit and a Grass Constant Current Unit. EMG recordings will be taken from the tibialis anterior muscle using self-adhesive surface electrodes. Data collection will include 20 series of 8 train pulses.
- Sex hormone fluctuations on cortical excitability using transcranial magnetic stimulation (TMS). [ Time Frame: 1 month ]MRI images will be acquired prior to the first TMS laboratory visit. The TMS coil will be positioned over the intersection of the central sulcus with the mid-sagittal plane using the subject's own anatomical MRI using an optical navigation system. Surface EMG will be recorded from muscles in the right leg. The paired-pulse paradigm isolates any modulatory influence of hormone concentration at cortex. With the subject seated with hip, knee, and ankle flexed at 90 degrees, TMS will be delivered to the leg area of the left motor cortex through using one of our TMS systems.
- Ovulation testing. [ Time Frame: 1 month ]Urine ovulation kit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03947684
|Contact: Pauline Phan, M.S.||214-648-7954||Pauline.Phan@UTSouthwestern.edu|
|Contact: Maria P Kabamalan||214-648-2755||MariaPia.Kabamalan@UTSouthwestern.edu|
|United States, Texas|
|UT Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Pauline Phan, M.S. 214-648-7954 Pauline.Phan@UTSouthwestern.edu|
|Contact: Maria P Kabamalan 214-648-2755 MariaPia.Kabamalan@UTSouthwestern.edu|
|Principal Investigator: Yasin Dhaher, Ph.D.|
|Principal Investigator:||Yasin Dhaher, Ph.D.||UT Southwestern Medical Center|