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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.
Patients age 18-85 years with (n=25) and without RLS (n=25) that have recently having undergone Spinal Cord Stimulation (SCS) implantation (thoracolumbar) for chronic pain will be recruited from the Departments of Anesthesia and Neurosurgery, University of Iowa Hospitals and Clinics. The rationale for studying both RLS patients and non-RLS patients with chronic back pain is to initially test the effectiveness of Spinal Cord Stimulation (SCS) on lower limb blood flow in the absence of symptoms of RLS. In the non-RLS patients, we could determine if SCS does in fact alter limb blood flow. We hypothesize that RLS patients have altered muscle sympathetic nerve activity (MSNA) and blood flow correlating to severity of RLS symptoms, which will then be modulated by Spinal Cord Stimulation (SCS), allowing for resolution of symptoms in RLS with MSNA-mediated improvements in leg blood flow. We also hypothesize that SCS in RLS patients will reduce 24-hour ambulatory blood pressure in parallel with reductions in MSNA.
Those deemed eligible to participate will be invited for 2 visits to the Translational Vascular Physiology Laboratory in the Clinical Research Unit (CRU) of the University of Iowa Hospitals and Clinics. Each of the 2 study visits are identical except for experimental measurements that are made at each of the five measurement time points when the Spinal Cord Stimulation (SCS) unit is either on or off as described below.
Visit 1: Experimental measurements include non-invasive "gold standard" measures of limb blood flow and arterial stiffness including femoral artery blood flow via Doppler ultrasound, calf blood flow from strain gauge venous occlusion plethysmography, and arterial stiffness via pulse wave velocity using applanation tonometry. Additionally, participants will be asked to assess the current level of leg discomfort every 10 minutes while measurements are taken by the SIT test, a validated technique for assessing restless legs symptoms where patients are asked to set and rest quietly during measurement talking, moving as little as possible (3).
Visit 2: Experimental measurements include direct measures of sympathetic nerve activity using microneurography before, during and again after administration of SCS to the patient. Additionally, participants will be asked to assess the current level of leg discomfort every 10 minutes while measurements are taken by the SIT test, a validated technique for assessing restless legs symptoms where patients are asked to set and rest quietly during measurement taking, moving as little as possible (3).
Some participates may visit the laboratory for placement of a 24-hour ambulatory blood pressure cuff.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with RLS | Experimental | Subjects with Restless Leg Syndrome that have recently undergone Spinal Cord Stimulation (SCS) Implantation for chronic pain. Subject will have received the standard of care intervention of epidural spinal cord stimulation for pain. |
|
| Subjects without RLS | Other | Subjects without Restless Leg Syndrome that have recently undergone Spinal Cord Stimulation (SCS) Implantation for chronic pain. Subject will have received the standard of care intervention of epidural spinal cord stimulation for pain. |
|
| Continous BP Monitoring | Other | This arm consists of subjects from arm "Subjects with RLS", "Subjects without RLS", and the rest of the qualifying subjects undergoing continuous blood pressure portion of the study only. Subject will have received the standard of care intervention of epidural spinal cord stimulation for pain. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual-energy X-ray absorptiometry Scan | Diagnostic Test | Body composition analysis will be obtained by DEXA scan. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change MSNA Burst Frequency From Baseline to 60 Minutes | Response will measured by peroneal nerve microneurography to the lower limb during epidural spinal cord stimulation in patients with chronic back pain. Percent change MSNA burst frequency from baseline to 60 minutes | Baseline to 60 minutes |
| Response Measurement of Thoracolumbar Epidural SCS in the Femoral Artery Blood Flow | The response will be measured by Doppler ultrasound of the femoral artery during epidural spinal cord stimulation in patients with chronic back pain. | Baseline and 1.5 Hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marshall Holland, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21795081 | Background | Ohayon MM, O'Hara R, Vitiello MV. Epidemiology of restless legs syndrome: a synthesis of the literature. Sleep Med Rev. 2012 Aug;16(4):283-95. doi: 10.1016/j.smrv.2011.05.002. Epub 2011 Jul 26. | |
| 12761367 | Background | Earley CJ. Clinical practice. Restless legs syndrome. N Engl J Med. 2003 May 22;348(21):2103-9. doi: 10.1056/NEJMcp021288. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects With RLS | Subjects with Restless Leg Syndrome that have recently undergone Spinal Cord Stimulation (SCS) Implantation for chronic pain. Subject will have received the standard of care intervention of epidural spinal cord stimulation for pain. First Visit (Day 1): Dual-energy X-ray absorptiometry Scan Laboratory Measurements: Pregnancy test (urine), glucose, insulin, catecholamine, and cholesterol (serum). Blood Flow Measurement: The blood flow to the arm or leg measured by ultrasonic probe on the skin over the femoral artery of leg and brachial artery of the arm. 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. Anthropometric Measurements: Height and weight will be obtained. Visit 2 (Day 2): Laboratory Measurements repeated as done in Visit 1. Blood Flow Measurement repeated as done in Visit 1. Partial pressure of oxygen repeated as done in Visit 1. Microneurography: Sympathetic nervous system activity to subject's leg muscles measured by a tiny microelectrode placed in peroneal nerve in the leg located just below the outer knee. When the nerve is located 2 sterile microelectrodes will be inserted through the skin. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 5, 2016 | Feb 28, 2023 |
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Subjects are assigned to one of two groups based on whether they have Restless Leg Syndrome to undergo experimental measurements that are made at each of the five measurement time points.
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|
| Laboratory Measurements | Other | The following labs will be obtained during the course of the study: pregnancy test (urine), glucose, insulin, catecholamine, and cholesterol (serum). |
|
| Blood Flow Measurement | Other | 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 | Other | 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 | Other | Transcutaneous recordings will be captured to measure the partial pressure of oxygen by placing monitors on the subject's chest and foot. |
|
| Microneurography | Other | 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 | Other | Height and weight will be obtained. |
|
| John Hopkins Restless Legs Severity Scale | Behavioral | Subjects will be administered questionnaires to evaluate RLS symptoms using John Hopkins Restless Legs Severity Scale. |
|
| Continuous Blood Pressure Diary | Behavioral | Subjects participating in Continuous Blood Pressure monitoring will be administered continuous blood pressure monitoring compliance diary. |
|
| 23814348 | Background | Garcia-Borreguero D, Kohnen R, Boothby L, Tzonova D, Larrosa O, Dunkl E. Validation of the Multiple Suggested Immobilization Test: A Test for the Assessment of Severity of Restless Legs Syndrome (Willis-Ekbom Disease). Sleep. 2013 Jul 1;36(7):1101-1109. doi: 10.5665/sleep.2820. |
| 15029914 | Background | Cameron T. Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 20-year literature review. J Neurosurg. 2004 Mar;100(3 Suppl Spine):254-67. doi: 10.3171/spi.2004.100.3.0254. |
| 23206679 | Background | Foreman RD, Linderoth B. Neural mechanisms of spinal cord stimulation. Int Rev Neurobiol. 2012;107:87-119. doi: 10.1016/B978-0-12-404706-8.00006-1. |
| 22038683 | Background | Yeh P, Walters AS, Tsuang JW. Restless legs syndrome: a comprehensive overview on its epidemiology, risk factors, and treatment. Sleep Breath. 2012 Dec;16(4):987-1007. doi: 10.1007/s11325-011-0606-x. Epub 2011 Oct 26. |
| 24048084 | Background | Dauvilliers Y, Winkelmann J. Restless legs syndrome: update on pathogenesis. Curr Opin Pulm Med. 2013 Nov;19(6):594-600. doi: 10.1097/MCP.0b013e328365ab07. |
| 23859128 | Background | Garcia-Borreguero D, Kohnen R, Silber MH, Winkelman JW, Earley CJ, Hogl B, Manconi M, Montplaisir J, Inoue Y, Allen RP. The long-term treatment of restless legs syndrome/Willis-Ekbom disease: evidence-based guidelines and clinical consensus best practice guidance: a report from the International Restless Legs Syndrome Study Group. Sleep Med. 2013 Jul;14(7):675-84. doi: 10.1016/j.sleep.2013.05.016. |
| 23746768 | Background | Hornyak M, Scholz H, Kohnen R, Bengel J, Kassubek J, Trenkwalder C. What treatment works best for restless legs syndrome? Meta-analyses of dopaminergic and non-dopaminergic medications. Sleep Med Rev. 2014 Apr;18(2):153-64. doi: 10.1016/j.smrv.2013.03.004. Epub 2013 Jun 6. |
| 8341893 | Background | Walters AS, Wagner ML, Hening WA, Grasing K, Mills R, Chokroverty S, Kavey N. Successful treatment of the idiopathic restless legs syndrome in a randomized double-blind trial of oxycodone versus placebo. Sleep. 1993 Jun;16(4):327-32. doi: 10.1093/sleep/16.4.327. |
| 6148892 | Background | Goldberg LI. Dopamine receptors and hypertension. Physiologic and pharmacologic implications. Am J Med. 1984 Oct 5;77(4A):37-44. doi: 10.1016/s0002-9343(84)80036-4. |
| 18083639 | Background | Wu M, Linderoth B, Foreman RD. Putative mechanisms behind effects of spinal cord stimulation on vascular diseases: a review of experimental studies. Auton Neurosci. 2008 Feb 29;138(1-2):9-23. doi: 10.1016/j.autneu.2007.11.001. |
| FG001 | Subjects Without RLS | Subjects without Restless Leg Syndrome that have recently undergone Spinal Cord Stimulation (SCS) Implantation for chronic pain. Subject will have received the standard of care intervention of epidural spinal cord stimulation for pain. First Visit (Day 1): Dual-energy X-ray absorptiometry Scan Laboratory Measurements: Pregnancy test (urine), glucose, insulin, catecholamine, and cholesterol (serum). Blood Flow Measurement: The blood flow to the arm or leg measured by ultrasonic probe on the skin over the femoral artery of leg and brachial artery of the arm. 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. Anthropometric Measurements: Height and weight will be obtained. Visit 2 (Day 2): Laboratory Measurements repeated as done in Visit 1. Blood Flow Measurement repeated as done in Visit 1. Partial pressure of oxygen repeated as done in Visit 1. Microneurography: Sympathetic nervous system activity to subject's leg muscles measured by a tiny microelectrode placed in peroneal nerve in the leg located just below the outer knee. When the nerve is located 2 sterile microelectrodes will be inserted through the skin. |
| FG002 | Continous BP Monitoring | This arm consists of subjects from arm "Subjects with RLS", "Subjects without RLS", and the rest of the qualifying subjects undergoing continuous blood pressure portion of the study only. Subject will have received the standard of care intervention of epidural spinal cord stimulation for pain. 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. Continuous Blood Pressure Diary: Subjects participating in Continuous Blood Pressure monitoring will be administered continuous blood pressure monitoring compliance diary. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
There were no subjects enrolled in the Continuous BP Monitoring Arm
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects With RLS | Subjects with Restless Leg Syndrome that have recently undergone Spinal Cord Stimulation (SCS) Implantation for chronic pain. Intervention: Use of epidural spinal cord stimulation. Dual-energy X-ray absorptiometry Scan: Body composition analysis will be obtained by DEXA scan. Laboratory Measurements: The following labs will be obtained: 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. 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. Continuous Blood Pressure Diary: Subjects participating in Continuous Blood Pressure monitoring will be administered continuous blood pressure monitoring compliance diary. |
| BG001 | Subjects Without RLS | Subjects without Restless Leg Syndrome that have recently undergone Spinal Cord Stimulation (SCS) Implantation for chronic pain. Intervention: Use of epidural spinal cord stimulation. 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 John Hopkins Restless Legs Severity Scale |
| BG002 | Continous BP Monitoring | This arm consists of subjects from arm "Subjects with RLS", "Subjects without RLS", and the rest of the qualifying subjects undergoing continuous blood pressure portion of the study only. Intervention: Use of epidural spinal cord stimulation. 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. Continuous Blood Pressure Diary: Subjects participating in Continuous Blood Pressure monitoring will be administered continuous blood pressure monitoring compliance diary. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change MSNA Burst Frequency From Baseline to 60 Minutes | Response will measured by peroneal nerve microneurography to the lower limb during epidural spinal cord stimulation in patients with chronic back pain. Percent change MSNA burst frequency from baseline to 60 minutes | All subjects enrolled did not complete this test or the test was terminated prior to a result being collected. The peroneal nerve signal is difficult to acquire and maintain with a small electrode through the skin, sometimes it can be lost half way if the patient moves their leg. Optional Continuous BP Monitoring did not have any subjects enrolled. | Posted | Mean | Standard Deviation | Percent change MSNA burst frequency | Baseline to 60 minutes |
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| Primary | Response Measurement of Thoracolumbar Epidural SCS in the Femoral Artery Blood Flow | The response will be measured by Doppler ultrasound of the femoral artery during epidural spinal cord stimulation in patients with chronic back pain. | Not all subjects that were enrolled completed this test. Optional Continuous BP Monitoring sub-study did not have any participants enrolled. | Posted | Mean | Standard Deviation | percentage of change | Baseline and 1.5 Hours |
|
Adverse Events and Serious Adverse Events were collected during enrollment period, up to 2 months.
Medical record review and directly from participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects With RLS | Subjects with Restless Leg Syndrome that have recently undergone Spinal Cord Stimulation (SCS) Implantation for chronic pain. Intervention: Use of epidural spinal cord stimulation. 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. 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. Continuous Blood Pressure Diary: Subjects participating in Continuous Blood Pressure monitoring will be administered continuous blood pressure monitoring compliance diary. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG001 | Subjects Without RLS | Subjects without Restless Leg Syndrome that have recently undergone Spinal Cord Stimulation (SCS) Implantation for chronic pain. Intervention: Use of epidural spinal cord stimulation. Dual-energy X-ray absorptiometry Scan: Body composition analysis will be obtained by DEXA scan. Laboratory Measurements: 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. 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. John Hopkins Restless Legs Severity Scale: Subjects will be administered questionnaires to evaluate RLS symptoms using John Hopkins Restless Legs Severity Scale. Continuous Blood Pressure Diary: Subjects participating in Continuous Blood Pressure monitoring will be administered continuous blood pressure monitoring compliance diary. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Continous BP Monitoring | This arm consists of subjects from arm "Subjects with RLS", "Subjects without RLS", and the rest of the qualifying subjects undergoing continuous blood pressure portion of the study only. Intervention: Use of epidural spinal cord stimulation. 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. Continuous Blood Pressure Diary: Subjects participating in Continuous Blood Pressure monitoring will be administered continuous blood pressure monitoring compliance diary. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marshall Holland, MD | University of Iowa | 205-934-2654 | mtholland@uabmc.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 10, 2023 | Jul 7, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 2, 2020 | Feb 28, 2023 | ICF_002.pdf |
| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D020447 | Parasomnias |
| D001523 | Mental Disorders |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015502 | Absorptiometry, Photon |
| D015924 | Blood Pressure Monitors |
| C093415 | PO-2 |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003720 | Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D019722 | Sphygmomanometers |
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
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| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Subjects Without RLS | Subjects without Restless Leg Syndrome that have recently undergone Spinal Cord Stimulation (SCS) Implantation for chronic pain. Intervention: Use of epidural spinal cord stimulation. 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. 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. John Hopkins Restless Legs Severity Scale: Subjects will be administered questionnaires to evaluate RLS symptoms using John Hopkins Restless Legs Severity Scale. |
| OG002 | Continous BP Monitoring | This arm consists of subjects from arm "Subjects with RLS", "Subjects without RLS", and the rest of the qualifying subjects undergoing continuous blood pressure portion of the study only. Intervention: Use of epidural spinal cord stimulation. 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. Continuous Blood Pressure Diary: Subjects participating in Continuous Blood Pressure monitoring will be administered continuous blood pressure monitoring compliance diary. |
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