Recruiting

SCS & TMS

Sponsor:

University of Alabama at Birmingham

Code:

NCT07179406

Conditions

Restless Leg Syndrome (RLS)

Spinal Cord Stimulation (SCS)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

H-Reflex

Somatosensory evoked potential (SSEP)

Vibratory Electrophysiological Response Potential (ERP)

Transcranial Magnetic Stimulation (TMS)

Spinal Cord Stimulator (SCS) manipulation

Study Details

Brief summary:

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.

Conditions

Restless Leg Syndrome (RLS)

Spinal Cord Stimulation (SCS)

Study ID

NCT07179406

Start date

Aug 4, 2025

Status verified date

Jun, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

H-Reflex

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 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)

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

Spinal cord stimulator will be turned on/off

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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Marshall Holland, MD

2059343411mtholland@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Marshall Holland, MD

2059343411mtholland@uabmc.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-06-26.