An interventional study of H-Reflex and Somatosensory evoked potential (SSEP) in Restless Leg Syndrome (RLS) and Spinal Cord Stimulation (SCS), sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Basic science
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.
248 studies on the registry are indexed under Restless Legs Syndrome; 39 are open to participants now.
This study's planned enrollment of 50 is close to the median of 53 across 196 interventional studies indexed under Restless Legs Syndrome.
Browse Restless Legs Syndrome studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
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Exclusion Criteria:
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.
Other: H-Reflex · Other: Somatosensory evoked potential (SSEP) · Other: Vibratory Electrophysiological Response Potential (ERP) · Other: Transcranial Magnetic Stimulation (TMS)
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.
Other: H-Reflex · Other: Somatosensory evoked potential (SSEP) · Other: Vibratory Electrophysiological Response Potential (ERP) · Other: Transcranial Magnetic Stimulation (TMS) · Other: Spinal Cord Stimulator (SCS) manipulation
Participants will perform the same procedures as those in Arm 2, but only after 2-3 weeks from receiving a permanent SCS.
Other: H-Reflex · Other: Somatosensory evoked potential (SSEP) · Other: Vibratory Electrophysiological Response Potential (ERP) · Other: Transcranial Magnetic Stimulation (TMS) · Other: Spinal Cord Stimulator (SCS) manipulation
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.
Other: H-Reflex · Other: Somatosensory evoked potential (SSEP) · Other: Vibratory Electrophysiological Response Potential (ERP) · Other: Transcranial Magnetic Stimulation (TMS) · Other: Spinal Cord Stimulator (SCS) manipulation
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.
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.
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.
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.
Spinal cord stimulator will be turned on/off
Changes in H-reflex neurophysiological activity in response to Spinal Cord Stimulation (SCS)
Time frame: Up to 3 Weeks after consent to the study
Changes in Somatosensory Evoked Potential (SSEP) activity in response to Spinal Cord Stimulation (SCS)
Time frame: Up to 3 Weeks after consent to the study
Changes in Vibratory Electrophysiological Response Potential (ERP) activity in response to Spinal Cord Stimulation (SCS)
Time frame: Up to 3 Weeks after consent to the study
Changes in Transcranial Magnetic Stimulation (TMS) activity in response to Spinal Cord Stimulation (SCS)
Time frame: Up to 3 Weeks after consent to the study
Changes in self-reported RLS symptoms via International Restless Legs Syndrome (IRLSS) Questionnaire
Time frame: Up to 3 Weeks after consent to the study
Changes in self-reported pain symptoms via Promis Questionnaire
Time frame: Up to 3 Weeks after consent to the study
Changes in self-reported pain symptoms via PainDetect Questionnaire
Time frame: Up to 3 Weeks after consent to the study
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University of Alabama at Birmingham