The Effect of Spinal Cord Stimulators on Restless Leg Syndrome

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07179406
Status
Recruiting
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Conditions

  • Restless Leg Syndrome (RLS)
  • Spinal Cord Stimulation (SCS)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.
  • 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.
  • 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.
  • 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.
  • Spinal Cord Stimulator (SCS) manipulation — OTHER
    Spinal cord stimulator will be turned on/off

Study Details

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.

Key Dates

Start date
Aug 4, 2025
Status verified
Jan 2026
Primary completion
Jan 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: 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.
  • Active Comparator: 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.
  • Active Comparator: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Changes in H-reflex neurophysiological activity in response to Spinal Cord Stimulation (SCS) [ Time Frame: Up to 3 Weeks after consent to the study ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Marshall Holland, MD
[email protected]
2059343411

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By research site
University of Alabama at Birmingham· Birmingham, AL

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