Neurophysiological Effects of Medication Tapering During Treatment With Spinal Cord Stimulation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBrai²n

About this trial

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 criteria

Qualifiers

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).

No strong opioids or anticonvulsants, or other analgesics

Monotherapy with a strong opioid, or

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Spinal Cord Stimulation with Evoke Closed-Loop System

Treatment groups

50 Participants
are divided into 3 treatment groups

Sponsors and collaborators