Spinal Cord Stimulation for Restless Legs Syndrome

Summary

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.

Conditions

• Restless Legs Syndrome
• Neuropathic 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.

Sponsors & Collaborators

• Marshall Holland

  lead OTHER

Principal Investigators

• Marshall Holland, MD · University of Iowa

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-07-05

Primary Completion

2020-04-23

Completion

2020-04-23

FDA Device

Yes

Countries

• United States

Study Locations