Spinal Cord Stimulation for Restless Legs Syndrome

NACompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

July 5, 2016

Primary Completion Date

April 23, 2020

Study Completion Date

April 23, 2020

Conditions
Restless Legs SyndromeNeuropathic Pain
Interventions
DIAGNOSTIC_TEST

Dual-energy X-ray absorptiometry Scan

Body composition analysis will be obtained by DEXA scan.

OTHER

Laboratory Measurements

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

OTHER

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.

OTHER

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.

OTHER

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.

OTHER

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.

OTHER

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.

Trial Locations (1)

52242

University of Iowa Hospitals and Clinics, Iowa City

All Listed Sponsors
lead

Marshall Holland

OTHER

NCT03539081 - Spinal Cord Stimulation for Restless Legs Syndrome | Biotech Hunter | Biotech Hunter