The Effect of Spinal Cord Stimulators on Restless Leg Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes in H-reflex neurophysiological activity in response to Spinal Cord Stimulation (SCS)
研究概览
简要总结
This study aims to evaluate neurophysiological responses and symptom changes in individuals with Restless Legs Syndrome (RLS) and/or chronic pain. Participants will undergo standard clinical assessments including EEG, EMG, h-reflex, SSEP, ERP, and TMS under varying SCS conditions.The study involves 4 arms. Arm 1 are individuals diagnosed with RLS and Healthy Controls. Arm 2 are individuals diagnosed with RLS and have an existing SCS. Arm 3 are individuals diagnosed with RLS and scheduled to receive a SCS. Arm 4 are individuals with chronic pain and have a SCS, but no diagnosis of RLS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has Restless Leg Syndrome
- •No major changes in RLS medications in past 4 weeks
- •Willing and able to comply with study protocol
- •Healthy Controls - No RLS diagnosis
- •Ability to provide informed consent
排除标准
- •Any mental or physical limitation that would prevent completing any of the studies
- •Currently using another device to treat RLS
- •Unable or unwilling to comply with study protocols
- •Other medical condition that would put the subject at risk as determined by the investigator
- •Pregnant, breastfeeding, or trying to become pregnant
- •Currently participating or planning to participate in any other investigational clinical evaluation during the study period that may, in the opinion of the investigator, affect RLS
- •One or more of the following diseases: spinal cord injury, severe peripheral neuropathy or radiculopathy, severe psychiatric or cognitive disorder that may interfere with participation of the study, history of drug or alcohol abuse within the past year, epilepsy or seizure disorder, current active or chronic infection other than the common cold, malignancy within the past 5 years (not including basal cell or squamous cell skin cancer), severe movement disorder (i.e. Parkinson's disease), deep vein thrombosis, or multiple sclerosis.
研究组 & 干预措施
Arm 1: Assessments and questionnaires only
Complete questionnaires on RLS and pain
Stimulation:
H-reflex - A small electrical stimulus is provided to the leg and foot area and a measurement of the stimulus is taken by the EEG electrodes.
Somatosensory evoked potential (SSEP) - A small electrical stimulus is provided to a nerve on the body and measured at several places along the nervous system (spinal cord, brain, etc.) with the EMG and EEG electrodes.
Vibratory Electrophysiological Response Potential (ERP) - stimulation of the ankle with vibration sensations using a device like a buzzer and recording of body's responses using the EEG and/or EMG electrodes.
Transcranial Magnetic Stimulation (TMS) - A small magnetic pulse is used to provide a small amount of electrical stimulation to nervous system. The EEG and/or EMG electrodes will be used to measure body's reaction.
干预措施: H-Reflex (Other)
Arm 3: Off-on-off post-op
Participants will perform the same procedures as those in Arm 2, but only after 2-3 weeks from receiving a permanent SCS.
干预措施: Transcranial Magnetic Stimulation (TMS) (Other)
Arm 3: Off-on-off post-op
Participants will perform the same procedures as those in Arm 2, but only after 2-3 weeks from receiving a permanent SCS.
干预措施: Spinal Cord Stimulator (SCS) manipulation (Other)
Arm 1: Assessments and questionnaires only
Complete questionnaires on RLS and pain
Stimulation:
H-reflex - A small electrical stimulus is provided to the leg and foot area and a measurement of the stimulus is taken by the EEG electrodes.
Somatosensory evoked potential (SSEP) - A small electrical stimulus is provided to a nerve on the body and measured at several places along the nervous system (spinal cord, brain, etc.) with the EMG and EEG electrodes.
Vibratory Electrophysiological Response Potential (ERP) - stimulation of the ankle with vibration sensations using a device like a buzzer and recording of body's responses using the EEG and/or EMG electrodes.
Transcranial Magnetic Stimulation (TMS) - A small magnetic pulse is used to provide a small amount of electrical stimulation to nervous system. The EEG and/or EMG electrodes will be used to measure body's reaction.
干预措施: Somatosensory evoked potential (SSEP) (Other)
Arm 1: Assessments and questionnaires only
Complete questionnaires on RLS and pain
Stimulation:
H-reflex - A small electrical stimulus is provided to the leg and foot area and a measurement of the stimulus is taken by the EEG electrodes.
Somatosensory evoked potential (SSEP) - A small electrical stimulus is provided to a nerve on the body and measured at several places along the nervous system (spinal cord, brain, etc.) with the EMG and EEG electrodes.
Vibratory Electrophysiological Response Potential (ERP) - stimulation of the ankle with vibration sensations using a device like a buzzer and recording of body's responses using the EEG and/or EMG electrodes.
Transcranial Magnetic Stimulation (TMS) - A small magnetic pulse is used to provide a small amount of electrical stimulation to nervous system. The EEG and/or EMG electrodes will be used to measure body's reaction.
干预措施: Vibratory Electrophysiological Response Potential (ERP) (Other)
Arm 1: Assessments and questionnaires only
Complete questionnaires on RLS and pain
Stimulation:
H-reflex - A small electrical stimulus is provided to the leg and foot area and a measurement of the stimulus is taken by the EEG electrodes.
Somatosensory evoked potential (SSEP) - A small electrical stimulus is provided to a nerve on the body and measured at several places along the nervous system (spinal cord, brain, etc.) with the EMG and EEG electrodes.
Vibratory Electrophysiological Response Potential (ERP) - stimulation of the ankle with vibration sensations using a device like a buzzer and recording of body's responses using the EEG and/or EMG electrodes.
Transcranial Magnetic Stimulation (TMS) - A small magnetic pulse is used to provide a small amount of electrical stimulation to nervous system. The EEG and/or EMG electrodes will be used to measure body's reaction.
干预措施: Transcranial Magnetic Stimulation (TMS) (Other)
Arm 2: Off-on-off
Participants will turn OFF their SCS at least 48 hours prior to the visit. The assessments listed in Arm 1 will be performed and the SCS will be turned ON for at least 60 minutes before repeating the assessments. Participants may repeat the questionnaires during this waiting period.
Finally, the SCS is turned OFF again, this time for at least 30 minutes before repeating the assessments, except for the h-reflex, which will not be needed again. As with before, participants can complete the questionnaires during this waiting period.
干预措施: H-Reflex (Other)
Arm 2: Off-on-off
Participants will turn OFF their SCS at least 48 hours prior to the visit. The assessments listed in Arm 1 will be performed and the SCS will be turned ON for at least 60 minutes before repeating the assessments. Participants may repeat the questionnaires during this waiting period.
Finally, the SCS is turned OFF again, this time for at least 30 minutes before repeating the assessments, except for the h-reflex, which will not be needed again. As with before, participants can complete the questionnaires during this waiting period.
干预措施: Somatosensory evoked potential (SSEP) (Other)
Arm 2: Off-on-off
Participants will turn OFF their SCS at least 48 hours prior to the visit. The assessments listed in Arm 1 will be performed and the SCS will be turned ON for at least 60 minutes before repeating the assessments. Participants may repeat the questionnaires during this waiting period.
Finally, the SCS is turned OFF again, this time for at least 30 minutes before repeating the assessments, except for the h-reflex, which will not be needed again. As with before, participants can complete the questionnaires during this waiting period.
干预措施: Vibratory Electrophysiological Response Potential (ERP) (Other)
Arm 2: Off-on-off
Participants will turn OFF their SCS at least 48 hours prior to the visit. The assessments listed in Arm 1 will be performed and the SCS will be turned ON for at least 60 minutes before repeating the assessments. Participants may repeat the questionnaires during this waiting period.
Finally, the SCS is turned OFF again, this time for at least 30 minutes before repeating the assessments, except for the h-reflex, which will not be needed again. As with before, participants can complete the questionnaires during this waiting period.
干预措施: Transcranial Magnetic Stimulation (TMS) (Other)
Arm 2: Off-on-off
Participants will turn OFF their SCS at least 48 hours prior to the visit. The assessments listed in Arm 1 will be performed and the SCS will be turned ON for at least 60 minutes before repeating the assessments. Participants may repeat the questionnaires during this waiting period.
Finally, the SCS is turned OFF again, this time for at least 30 minutes before repeating the assessments, except for the h-reflex, which will not be needed again. As with before, participants can complete the questionnaires during this waiting period.
干预措施: Spinal Cord Stimulator (SCS) manipulation (Other)
Arm 3: Off-on-off post-op
Participants will perform the same procedures as those in Arm 2, but only after 2-3 weeks from receiving a permanent SCS.
干预措施: H-Reflex (Other)
Arm 3: Off-on-off post-op
Participants will perform the same procedures as those in Arm 2, but only after 2-3 weeks from receiving a permanent SCS.
干预措施: Somatosensory evoked potential (SSEP) (Other)
Arm 3: Off-on-off post-op
Participants will perform the same procedures as those in Arm 2, but only after 2-3 weeks from receiving a permanent SCS.
干预措施: Vibratory Electrophysiological Response Potential (ERP) (Other)
Arm 4: On-off-on
Participants will have their SCS on for at least 48 hours prior to the visit. The assessments listed in Arm 1 will be performed and the SCS will be turned Off for at least 60 minutes before repeating the assessments. Participants may repeat the questionnaires during this waiting period.
Finally, the SCS is turned On again, this time for at least 30 minutes before repeating the assessments, except for the h-reflex, which will not be needed again. As with before, participants can complete the questionnaires during this waiting period.
干预措施: H-Reflex (Other)
Arm 4: On-off-on
Participants will have their SCS on for at least 48 hours prior to the visit. The assessments listed in Arm 1 will be performed and the SCS will be turned Off for at least 60 minutes before repeating the assessments. Participants may repeat the questionnaires during this waiting period.
Finally, the SCS is turned On again, this time for at least 30 minutes before repeating the assessments, except for the h-reflex, which will not be needed again. As with before, participants can complete the questionnaires during this waiting period.
干预措施: Somatosensory evoked potential (SSEP) (Other)
Arm 4: On-off-on
Participants will have their SCS on for at least 48 hours prior to the visit. The assessments listed in Arm 1 will be performed and the SCS will be turned Off for at least 60 minutes before repeating the assessments. Participants may repeat the questionnaires during this waiting period.
Finally, the SCS is turned On again, this time for at least 30 minutes before repeating the assessments, except for the h-reflex, which will not be needed again. As with before, participants can complete the questionnaires during this waiting period.
干预措施: Vibratory Electrophysiological Response Potential (ERP) (Other)
Arm 4: On-off-on
Participants will have their SCS on for at least 48 hours prior to the visit. The assessments listed in Arm 1 will be performed and the SCS will be turned Off for at least 60 minutes before repeating the assessments. Participants may repeat the questionnaires during this waiting period.
Finally, the SCS is turned On again, this time for at least 30 minutes before repeating the assessments, except for the h-reflex, which will not be needed again. As with before, participants can complete the questionnaires during this waiting period.
干预措施: Transcranial Magnetic Stimulation (TMS) (Other)
Arm 4: On-off-on
Participants will have their SCS on for at least 48 hours prior to the visit. The assessments listed in Arm 1 will be performed and the SCS will be turned Off for at least 60 minutes before repeating the assessments. Participants may repeat the questionnaires during this waiting period.
Finally, the SCS is turned On again, this time for at least 30 minutes before repeating the assessments, except for the h-reflex, which will not be needed again. As with before, participants can complete the questionnaires during this waiting period.
干预措施: Spinal Cord Stimulator (SCS) manipulation (Other)
结局指标
主要结局
Changes in H-reflex neurophysiological activity in response to Spinal Cord Stimulation (SCS)
时间窗: Up to 3 Weeks after consent to the study
Changes in Somatosensory Evoked Potential (SSEP) activity in response to Spinal Cord Stimulation (SCS)
时间窗: Up to 3 Weeks after consent to the study
Changes in Vibratory Electrophysiological Response Potential (ERP) activity in response to Spinal Cord Stimulation (SCS)
时间窗: Up to 3 Weeks after consent to the study
Changes in Transcranial Magnetic Stimulation (TMS) activity in response to Spinal Cord Stimulation (SCS)
时间窗: Up to 3 Weeks after consent to the study
次要结局
- Changes in self-reported RLS symptoms via International Restless Legs Syndrome (IRLSS) Questionnaire(Up to 3 Weeks after consent to the study)
- Changes in self-reported RLS symptoms via RLS-6 Questionnaire(Up to 3 Weeks after consent to the study)
- Changes in self-reported pain symptoms via Promis Questionnaire(Up to 3 Weeks after consent to the study)
- Changes in self-reported pain symptoms via PainDetect Questionnaire(Up to 3 Weeks after consent to the study)
研究者
Marshall Holland
Assistant Professor
University of Alabama at Birmingham