Neurophysiological Effects of Medication Tapering During Treatment With Spinal Cord Stimulation

NCT07413731 | Recruiting

• 1 other identifier: Multicentric-ZAS-ECAP-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Persistent Spinal Pain Syndrome Type 2 (PSPS-T2), Lower Spine; Spinal Cord Sensitivity to Neurostimulation; Neurophysiological Sensitivity to Spinal Cord Stimulation

Keywords

Spinal cord stimulation; Closed-loop stimulation; Evoked Compound Action Potentials (ECAPs); Neurophysiology; Pain medication tapering; Opioids; Anticonvulsants; Neuromodulation

Outcome Measures

Primary Outcomes (1)

• Spinal cord sensitivity expressed in ECAP amplitude (µV) as a function of the SCS stimulation amplitude (mA).

  Spinal cord sensitivity to spinal cord stimulation (SCS), will be assessed using activation plots describing the relationship between SCS stimulation current (mA) and the resultant Evoked Compound Action Potential (ECAP) amplitude (µV). Change is spinal cord sensitivity (µV/mA) will be compared between the SCS trial phase and at 1 month after permanent implantation across the different medication groups.

  From start of SCS trial (baseline) to 1 month after permanent implantation.

Secondary Outcomes (3)

• Change in pain intensity measured using a 10 cm Visual Analog Scale (VAS)

  From start of SCS trial (baseline) to 1 month after permanent implantation.

• Change in pain medication intake measured via Belgian Pain Platform (BPP) and clinical verification

  From start of SCS trial (baseline) to 1 month after permanent implantation.

• Change in neurophysiological parameters such as conduction velocity (m/sec), rheobase (mA) and chronaxie (µs), measured using the Evoke system's neurophysiological assessment tools.

  From start of SCS trial (baseline) to 1 month after permanent implantation.

Study Arms (3)

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.

Other: Spinal Cord Stimulation with Evoke Closed-Loop System

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).

Other: Spinal Cord Stimulation with Evoke Closed-Loop System

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).

Other: Spinal Cord Stimulation with Evoke Closed-Loop System

Interventions

Spinal Cord Stimulation with Evoke Closed-Loop System OTHER

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).

Monotherapy with anticonvulsants; Monotherapy with strong opioids; Without strong opioids or anticonvulsants or other analgesic drugs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Belgian patients selected for spinal cord stimulation (SCS) with Persistent Spinal Pain Syndrome Type 2 (lower spine).

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Brai²n: lead

Study Sites (1)

Brai²n - ZAS Augustinus

Wilrijk, 2610, Belgium

RECRUITING

Related Publications (2)

• Moens M, Crunelle CL, Putman K, Wuyts E, Bultinck F, Van Puyenbroeck H; PIANISSIMO consortium; Goudman L. Pain medication tapering for patients with Persistent Spinal Pain Syndrome Type II, treated with Spinal Cord Stimulation: A RCT-study protocol of the PIANISSIMO study. PLoS One. 2024 Aug 12;19(8):e0302842. doi: 10.1371/journal.pone.0302842. eCollection 2024.

  PMID: 39133680 BACKGROUND

• Nissen M, Ikaheimo TM, Huttunen J, Leinonen V, Jyrkkanen HK, von Und Zu Fraunberg M. Higher Preimplantation Opioid Doses Associated With Long-Term Spinal Cord Stimulation Failure in 211 Patients With Failed Back Surgery Syndrome. Neuromodulation. 2021 Jan;24(1):102-111. doi: 10.1111/ner.13297. Epub 2020 Oct 19.

  PMID: 33073907 BACKGROUND

MeSH Terms

Interventions

Spinal Cord Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Tony Van Havenbergh, MD

  Brai²n / Department of Neurosurgery, ZAS Augustinus, Antwerp, Belgium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pieter Van Looy

CONTACT

+32 3 443 48 72; pieter.vanlooy@zas.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of Neurosurgery (NeurochirurgieGroep); Director, Antwerp Skull Base Team; Director, Brai²n

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: February 17, 2026
• Study Start: February 3, 2025
• Primary Completion (Estimated): February 3, 2027
• Study Completion (Estimated): April 3, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)