RecruitingNCT07413731

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


Sponsor

Brai²n

Enrollment

50 participants

Start Date

Feb 3, 2025

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Spinal Cord Stimulation with Evoke Closed-Loop System for people with neurophysiological sensitivity to spinal cord stimulation, persistent spinal pain syndrome type 2 (psps-t2), lower spine, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERSpinal Cord Stimulation with Evoke Closed-Loop System

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)

Brai²n - ZAS Augustinus

Wilrijk, Belgium

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NCT07413731


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