Neurophysiological Effects of Medication Tapering During Treatment With Spinal Cord Stimulation
Assessment of Neurophysiological Effects of Medication Tapering During Treatment With ECAP Controlled Closed-loop Spinal Cord Stimulation Trial Periods
Brai²n
50 participants
Feb 3, 2025
OBSERVATIONAL
Conditions
Summary
This study is being conducted in patients who will receive a spinal cord stimulator. This device helps manage chronic neuropathic pain in the trunk and/or limbs. The patients will receive a spinal cord stimulator that is available, notified, and reimbursed in Belgium, which uses a special technology automatically adjusting the intensity of the stimulation. This is called a closed-loop system. The closed-loop system stimulates the Beta fibers in the spinal cord and simultaneously measures their response. Based on the measured response, the stimulation strength is automatically adjusted. In Belgium, after implant of the leads the effect must first be evalauted for 3 weeks before implanting the Internal Pulse Generator; this is called the trial period. Only if the trial is successful, the patients will receive a permanent implant. The primary goal of the study is to evaluate how different types of pain medication influence the neurophysiological response of the Beta fibers during spinal cord stimulation. Patients will be divided into three groups, based on the medication they are taking before receiving a spinal cord stimulator: * patients not taking any pain medication, * patients taking strong opioids, * patients taking anticonvulsant medication. As part of the study, patients will follow the normal clinical schedule. During visits, they will be asked questions about their pain, sleep, medication use, and activity. The study will end one month after the patient receives the permanent spinal cord stimulator implant.
Eligibility
Inclusion Criteria9
- Patient deemed a suitable candidate for SCS and routinely scheduled to undergo a trial phase with the Evoke SCS system.
- Diagnosis of Persistent Spinal Pain Syndrome Type 2 (lower spine).
- Current medication use:
- No strong opioids or anticonvulsants, or other analgesics
- Monotherapy with a strong opioid, or
- Monotherapy with an anticonvulsant.
- Willing and able to provide written informed consent to participate, based on a voluntary agreement after a full explanation of the study.
- Age ≥ 18 years at the time of enrollment.
- Willing and able to comply with study requirements, procedures, and follow-up visits.
Exclusion Criteria6
- Evidence of an active disruptive psychological or psychiatric disorder, or other condition significant enough to impact pain perception, compliance with intervention, or ability to evaluate outcomes (as determined by the investigator in consultation with a clinical psychologist).
- Current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumor, or severe/critical spinal stenosis.
- Current diagnosis or condition such as coagulation disorder, bleeding diathesis, platelet dysfunction, progressive peripheral vascular disease, or uncontrolled diabetes mellitus that presents excess risk for the procedure (as determined by the investigator).
- Active systemic or local infection.
- Pregnancy.
- Within 6 months prior to enrollment: significant untreated addiction to dependency-producing medications or a history of substance abuse (including alcohol or illicit drugs).
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Interventions
All participants will undergo trial stimulation with the Evoke ECAP-controlled closed-loop spinal cord stimulation system, followed by permanent implantation if the trial phase is successful. Neurophysiological parameters (activation plots, conduction velocity, chronaxie, rheobase) will be assessed alongside patient-reported outcomes (pain intensity, sleep, activity, medication use).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07413731