common.study.topics.clinical

Spinal Cord Stimulation for Restless Legs Syndrome

common.study.values.description

Spinal Cord Stimulation for Restless Legs Syndrome

The overall goal of this proposed study is to evaluate the underlying mechanisms of neural control of blood flow in the lower extremities in humans with restless leg syndrome (RLS). At least 15% of the general public suffers from RLS and many more may go undiagnosed. This unfortunate disorder leads primarily to a disturbing sensation within the patient's lower extremities that requires movement for relief (1, 2). The central hypothesis of our study is that physiological changes in lower limb blood flow as a result of thoracolumbar epidural Spinal Cord Stimulation (SCS) lead to the relief of RLS.

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participant.ui.study.affiliations-map.online-study.header-virtual

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common.study.values.methods

No pharmaceutical medication involved common.study.methods.has-drugs-no
Patients and healthy individuals accepted common.study.methods.is-healthy-no

Diagnostic Test - Dual-energy X-ray absorptiometry Scan

Body composition analysis will be obtained by DEXA scan.

Laboratory Measurements

The following labs will be obtained during the course of the study: pregnancy test (urine), glucose, insulin, catecholamine, and cholesterol (serum).

Blood Flow Measurement

The blood flow to the arm or leg may also be measured by placing an ultrasonic probe on the skin over the femoral artery of the leg and the brachial artery of the arm.

Continuous Blood Pressure

Continuous Blood pressure cuff will worn for 2 days with spinal cord stimulator on and off (24 hour on and 24 hour off). Optional procedure.

Partial pressure of oxygen

Transcutaneous recordings will be captured to measure the partial pressure of oxygen by placing monitors on the subject's chest and foot.

Microneurography

The sympathetic nervous system activity to the subject's leg muscles will be measured by a tiny microelectrode placed in the peroneal nerve in the leg located just below the knee on the outer part of the leg. When the nerve is located 2 tiny sterile microelectrodes will be inserted through the skin.

Anthropometric Measurements

Height and weight will be obtained.

Behavioral - John Hopkins Restless Legs Severity Scale

Subjects will be administered questionnaires to evaluate RLS symptoms using John Hopkins Restless Legs Severity Scale.

Behavioral - Continuous Blood Pressure Diary

Subjects participating in Continuous Blood Pressure monitoring will be administered continuous blood pressure monitoring compliance diary.

participant.views.study.view.additional

participant.views.study.view.scientific-title

Investigating Mechanisms of Human Spinal Cord Stimulation for Purpose of Treating Restless Leg Syndrome

common.study.values.clinical-trial-id

NCT03539081

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