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| ID | Type | Description | Link |
|---|---|---|---|
| UAB | Other Identifier | UAB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Assessments and questionnaires only | Active Comparator | 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. |
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| Arm 2: Off-on-off | Active Comparator | 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. |
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| Arm 3: Off-on-off post-op |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H-Reflex | Other | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in H-reflex neurophysiological activity in response to Spinal Cord Stimulation (SCS) | Up to 3 Weeks after consent to the study | |
| Changes in Somatosensory Evoked Potential (SSEP) activity in response to Spinal Cord Stimulation (SCS) | Up to 3 Weeks after consent to the study | |
| Changes in Vibratory Electrophysiological Response Potential (ERP) activity in response to Spinal Cord Stimulation (SCS) | Up to 3 Weeks after consent to the study | |
| Changes in Transcranial Magnetic Stimulation (TMS) activity in response to Spinal Cord Stimulation (SCS) | Up to 3 Weeks after consent to the study |
| Measure | Description | Time Frame |
|---|---|---|
| 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 pain symptoms via Promis Questionnaire | Up to 3 Weeks after consent to the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marshall Holland, MD | Contact | 2059343411 | mtholland@uabmc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35233 | United States |
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Participants will perform the same procedures as those in Arm 2, but only after 2-3 weeks from receiving a permanent SCS. |
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| Arm 4: On-off-on | Active Comparator | 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. |
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| Somatosensory evoked potential (SSEP) | Other | 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. |
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| Vibratory Electrophysiological Response Potential (ERP) | Other | stimulation is provided to the ankle with vibration sensations using a device like a buzzer and the recording of the body's responses using the EEG and/or EMG electrodes. |
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| Transcranial Magnetic Stimulation (TMS) | Other | A small magnetic pulse is used to provide a small amount of electrical stimulation to the nervous system. The EEG and/or EMG electrodes will be used to measure the body's reaction. |
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| Spinal Cord Stimulator (SCS) manipulation | Other | Spinal cord stimulator will be turned on/off |
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| Changes in self-reported pain symptoms via PainDetect Questionnaire | Up to 3 Weeks after consent to the study |
| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D020447 | Parasomnias |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D006181 | H-Reflex |
| D005073 | Evoked Potentials, Somatosensory |
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D012023 | Reflex, Monosynaptic |
| D012018 | Reflex |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D005071 | Evoked Potentials |
| D000071080 | Cortical Excitability |
| D055724 | Electrophysiological Phenomena |
| D010829 | Physiological Phenomena |
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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