Trial Outcomes & Findings for Spinal Cord Stimulation for Restless Legs Syndrome (NCT NCT03539081)
NCT ID: NCT03539081
Last Updated: 2023-09-21
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Baseline to 60 minutes
Results posted on
2023-09-21
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
10
|
0
|
|
Overall Study
COMPLETED
|
2
|
7
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
0
|
|
Overall Study
MSNA testing not done due to nerve recording not being able to be done due to restless legs
|
1
|
0
|
0
|
Baseline Characteristics
Spinal Cord Stimulation for Restless Legs Syndrome
Baseline characteristics by cohort
| Measure |
Subjects With RLS
n=5 Participants
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.
|
Subjects Without RLS
n=10 Participants
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
|
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.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
—
|
14 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
—
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
—
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
—
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
10 participants
n=7 Participants
|
—
|
15 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to 60 minutesPopulation: 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.
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
Outcome measures
| Measure |
Subjects With RLS
n=1 Participants
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.
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.
|
Subjects Without RLS
n=4 Participants
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.
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.
|
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.
|
|---|---|---|---|
|
Percent Change MSNA Burst Frequency From Baseline to 60 Minutes
|
-29 Percent change MSNA burst frequency
Standard Deviation 1
|
-24 Percent change MSNA burst frequency
Standard Deviation 10
|
—
|
PRIMARY outcome
Timeframe: Baseline and 1.5 HoursPopulation: Not all subjects that were enrolled completed this test. Optional Continuous BP Monitoring sub-study did not have any participants enrolled.
The response will be measured by Doppler ultrasound of the femoral artery during epidural spinal cord stimulation in patients with chronic back pain.
Outcome measures
| Measure |
Subjects With RLS
n=4 Participants
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.
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.
|
Subjects Without RLS
n=8 Participants
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.
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.
|
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.
|
|---|---|---|---|
|
Response Measurement of Thoracolumbar Epidural SCS in the Femoral Artery Blood Flow
|
24 percentage of change
Standard Deviation 30
|
22 percentage of change
Standard Deviation 14
|
—
|
Adverse Events
Subjects With RLS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Subjects Without RLS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Continous BP Monitoring
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place