Restless Leg Syndrome (RLS), Spinal Cord Stimulation (SCS)
Conditions
Keywords
SCS, Spinal Cord Stimulation, RLS, Restless Leg Syndrome
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.
Interventions
OTHERH-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.
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.
OTHERVibratory 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.
OTHERTranscranial 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.
OTHERSpinal Cord Stimulator (SCS) manipulation
Spinal cord stimulator will be turned on/off
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in H-reflex neurophysiological activity in response to Spinal Cord Stimulation (SCS) | Up to 3 Weeks after consent to the study |
| Changes in Somatosensory Evoked Potential (SSEP) activity in response to Spinal Cord Stimulation (SCS) | Up to 3 Weeks after consent to the study |
| Changes in Vibratory Electrophysiological Response Potential (ERP) activity in response to Spinal Cord Stimulation (SCS) | Up to 3 Weeks after consent to the study |
| Changes in Transcranial Magnetic Stimulation (TMS) activity in response to Spinal Cord Stimulation (SCS) | Up to 3 Weeks after consent to the study |
Secondary
| Measure | Time frame |
|---|---|
| Changes in self-reported RLS symptoms via International Restless Legs Syndrome (IRLSS) Questionnaire | Up to 3 Weeks after consent to the study |
| Changes in self-reported pain symptoms via Promis Questionnaire | Up to 3 Weeks after consent to the study |
| Changes in self-reported pain symptoms via PainDetect Questionnaire | Up to 3 Weeks after consent to the study |
Countries
United States
Contacts
CONTACTMarshall Holland, MD
Outcome results
None listed