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Assessment of Neurophysiological Effects of Medication Tapering During Treatment With ECAP Controlled Closed-loop Spinal Cord Stimulation Trial Periods

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
Brai²n - ZAS Augustinus
RECRUITING
Wilrijk
Contact Information
Primary
Pieter Van Looy
pieter.vanlooy@zas.be
+32 3 443 48 72
Time Frame
Start Date: 2025-02-03
Estimated Completion Date: 2027-04-03
Participants
Target number of participants: 50
Treatments
Without strong opioids or anticonvulsants or other analgesic drugs
Patients with Persistent Spinal Pain Syndrome Type 2 (PSPS-T2) (lower spine) who are not taking any analgesic medication.
Monotherapy with strong opioids
Patients with Persistent Spinal Pain Syndrome Type 2 (PSPS-T2) (lower spine) treated with analgesic monotherapy consisting of strong opioids (e.g., morphine, oxycodone, hydromorphone, fentanyl, methadone, oxymorphone).
Monotherapy with anticonvulsants
Patients with Persistent Spinal Pain Syndrome Type 2 (PSPS-T2) (lower spine) treated with analgesic monotherapy consisting of anticonvulsants (e.g., gabapentin, pregabalin, carbamazepine, lamotrigine, topiramate).
Related Therapeutic Areas
Sponsors
Leads: Brai²n

This content was sourced from clinicaltrials.gov