Restless Leg Syndrome (RLS)NCT07179406

The Effect of Spinal Cord Stimulators on Restless Leg Syndrome

A study testing H-Reflex, Somatosensory evoked potential (SSEP) and Vibratory Electrophysiological Response Potential (ERP) in people with Restless Leg Syndrome (RLS) and Spinal Cord Stimulation (SCS), run by University of Alabama at Birmingham at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Restless Leg Syndrome (RLS), Spinal Cord Stimulation (SCS)
What is being tested?: H-Reflex, Somatosensory evoked potential (SSEP) and Vibratory Electrophysiological Response Potential (ERP)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 4 Aug 2025to 31 Dec 2028
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marshall Holland, MD contact

2059343411

mtholland@uabmc.edu

United States1 site, 1 recruiting

University of Alabama at Birmingham
Birmingham, Alabama, 35233
Marshall Holland, MD, 2059343411, mtholland@uabmc.edu
Recruiting

Other trials in United States

About this study

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)
Being tested: H-Reflex, Somatosensory evoked potential (SSEP), Vibratory Electrophysiological Response Potential (ERP), Transcranial Magnetic Stimulation (TMS), Spinal Cord Stimulator (SCS) manipulation
Keywords: SCS, Spinal Cord Stimulation, RLS, Restless Leg Syndrome
Medical subject headings: Restless Legs Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

H-ReflexOther
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) manipulationOther
Spinal cord stimulator will be turned on/off

Study groups in NCT07179406
Study group	Role	What they receive
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. Receives: Other: H-Reflex; Other: Somatosensory evoked potential (SSEP); Other: Vibratory Electrophysiological Response Potential (ERP); Other: Transcranial Magnetic Stimulation (TMS)
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. Receives: 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
Arm 3: Off-on-off post-op	Active comparator	Participants will perform the same procedures as those in Arm 2, but only after 2-3 weeks from receiving a permanent SCS. Receives: 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
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. Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in H-reflex neurophysiological activity in response to Spinal Cord Stimulation (SCS)
Measured: Up to 3 Weeks after consent to the study
Changes in Somatosensory Evoked Potential (SSEP) activity in response to Spinal Cord Stimulation (SCS)
Measured: Up to 3 Weeks after consent to the study
Changes in Vibratory Electrophysiological Response Potential (ERP) activity in response to Spinal Cord Stimulation (SCS)
Measured: Up to 3 Weeks after consent to the study
Changes in Transcranial Magnetic Stimulation (TMS) activity in response to Spinal Cord Stimulation (SCS)
Measured: Up to 3 Weeks after consent to the study

Secondary outcomes (3)

Changes in self-reported RLS symptoms via International Restless Legs Syndrome (IRLSS) Questionnaire
Measured: Up to 3 Weeks after consent to the study
Changes in self-reported pain symptoms via Promis Questionnaire
Measured: Up to 3 Weeks after consent to the study
Changes in self-reported pain symptoms via PainDetect Questionnaire
Measured: Up to 3 Weeks after consent to the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Aug 202531 Dec 2028

First posted17 Sep 2025
Study start4 Aug 2025
Primary completion31 Jan 2028 (estimated)
Study completion31 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Restless Leg Syndrome (RLS)Studies of the same condition, open and under way.
More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07179406
Sponsor's protocol ID: IRB-300014915
Other IDs: UAB
Status last verified: Jun 2026
First submitted: 28 Aug 2025
Last updated: 26 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Marshall Holland, MD

2059343411

mtholland@uabmc.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Spinal Cord Stimulators on Restless Leg Syndrome
ClinicalTrials.gov ID: NCT07179406
Acronym / sponsor ID: IRB-300014915
Conditions: Restless Leg Syndrome (RLS), Spinal Cord Stimulation (SCS)
Keywords: SCS, Spinal Cord Stimulation, RLS, Restless Leg Syndrome
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 50 participants (estimated)
Lead sponsor: University of Alabama at BirminghamUniversity, hospital or other
Study start: 4 Aug 2025 (actual)
Primary completion: 31 Jan 2028 (estimated)
Study completion: 31 Dec 2028 (estimated)
First posted: 17 Sep 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Arm 1: Assessments and questionnaires only	Active comparator	Other: H-Reflex, Other: Somatosensory evoked potential (SSEP), Other: Vibratory Electrophysiological Response Potential (ERP), Other: Transcranial Magnetic Stimulation (TMS)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.
Arm 2: Off-on-off	Active comparator	Other: H-Reflex, Other: Somatosensory evoked potential (SSEP), Other: Vibratory Electrophysiological Response Potential (ERP), Other: Transcranial Magnetic Stimulation (TMS), Other: Spinal Cord Stimulator (SCS) manipulationParticipants 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.
Arm 3: Off-on-off post-op	Active comparator	Other: H-Reflex, Other: Somatosensory evoked potential (SSEP), Other: Vibratory Electrophysiological Response Potential (ERP), Other: Transcranial Magnetic Stimulation (TMS), Other: Spinal Cord Stimulator (SCS) manipulationParticipants will perform the same procedures as those in Arm 2, but only after 2-3 weeks from receiving a permanent SCS.
Arm 4: On-off-on	Active comparator	Other: H-Reflex, Other: Somatosensory evoked potential (SSEP), Other: Vibratory Electrophysiological Response Potential (ERP), Other: Transcranial Magnetic Stimulation (TMS), Other: Spinal Cord Stimulator (SCS) manipulationParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
H-ReflexH-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.	Other	Arm 1: Assessments and questionnaires only, Arm 2: Off-on-off, Arm 3: Off-on-off post-op, Arm 4: On-off-on
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.	Other	Arm 1: Assessments and questionnaires only, Arm 2: Off-on-off, Arm 3: Off-on-off post-op, Arm 4: On-off-on
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.	Other	Arm 1: Assessments and questionnaires only, Arm 2: Off-on-off, Arm 3: Off-on-off post-op, Arm 4: On-off-on
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.	Other	Arm 1: Assessments and questionnaires only, Arm 2: Off-on-off, Arm 3: Off-on-off post-op, Arm 4: On-off-on
Spinal Cord Stimulator (SCS) manipulationSpinal cord stimulator will be turned on/off	Other	Arm 2: Off-on-off, Arm 3: Off-on-off post-op, Arm 4: On-off-on

Primary outcome

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

3 secondary outcomes

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Marshall Holland, MD contact

2059343411

mtholland@uabmc.edu

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marshall Holland, MD (2059343411, mtholland@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07179406.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.