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NCT Number: NCT07179406

The Effect of Spinal Cord Stimulators on Restless Leg Syndrome

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location status: Recruiting

Location contact

Marshall Holland, MD

CONTACT

[email protected]

2059343411

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Changes in H-reflex neurophysiological activity in response to Spinal Cord Stimulation (SCS)

    Time frame: Up to 3 Weeks after consent to the study

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Changes in self-reported RLS symptoms via International Restless Legs Syndrome (IRLSS) Questionnaire

    Time frame: Up to 3 Weeks after consent to the study

  2. Changes in self-reported pain symptoms via Promis Questionnaire

    Time frame: Up to 3 Weeks after consent to the study

  3. Changes in self-reported pain symptoms via PainDetect Questionnaire

    Time frame: Up to 3 Weeks after consent to the study

Study contacts

Contact information is provided by the study sponsor or research team.

Marshall Holland, MD

CONTACT

[email protected]

2059343411

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 17, 2025
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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