Persistent Spinal Pain Syndrome Type 2 (PSPS-T2), Lower SpineNCT07413731
Neurophysiological Effects of Medication Tapering During Treatment With Spinal Cord Stimulation
An observational study of Persistent Spinal Pain Syndrome Type 2 (PSPS-T2), Lower Spine and Spinal Cord Sensitivity to Neurostimulation, run by Brai²n at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Spinal Pain Syndrome Type 2 (PSPS-T2), Lower Spine, Spinal Cord Sensitivity to Neurostimulation, Neurophysiological Sensitivity to Spinal Cord Stimulation
- What is being tested?
- Spinal Cord Stimulation with Evoke Closed-Loop System
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Feb 2025to 3 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Belgian patients selected for spinal cord stimulation (SCS) with Persistent Spinal Pain Syndrome Type 2 (lower spine).
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Brai²n - ZAS Augustinus
Wilrijk, 2610
Pieter Van Looy, +32 3 443 48 72, pieter.vanlooy@zas.be
Tony Van Havenbergh, MD
About this study
Official title: Assessment of Neurophysiological Effects of Medication Tapering During Treatment With ECAP Controlled Closed-loop Spinal Cord Stimulation Trial Periods
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.
Read more
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.
Read the detailed description
Chronic neuropathic pain, particularly in patients with Persistent Spinal Pain Syndrome Type 2 (PSPS-T2, formerly FBSS), remains a major therapeutic challenge. Spinal cord stimulation (SCS) is an established therapy for patients with refractory pain. In Belgium, a 21-day trial period with an externalized epidural lead is mandatory before permanent implantation. During this trial, pain relief, improved sleep, increased activity, and reduction in pain medication intake must be documented in order to qualify for a permanent implant.
The Evoke™ Closed-Loop SCS system (Saluda Medical) is a CE-marked device used within its licensed indication in this study. This system uniquely records Evoked Compound Action Potentials (ECAPs) from the spinal cord, allowing continuous monitoring of neural activation. Closed-loop algorithms adjust stimulation output in real time based on measured ECAPs, thereby aiming to deliver consistent therapy within each patient's therapeutic window.
Recent pilot data and case reports have suggested that reductions in pain medication, particularly strong opioids and anticonvulsants, may alter spinal cord sensitivity to stimulation and ECAP parameters. A prospective pilot study performed at ZAS St. Augustinus Hospital (Belgium) demonstrated measurable changes in spinal cord sensitivity after medication reduction in patients implanted with the Evoke system. These findings suggest that medication tapering may influence neurophysiological responsiveness to SCS and highlight the importance of documenting this relationship systematically.
Study Design
This is a multicenter, open-label, prospective observational study enrolling 50 patients scheduled for SCS with the Evoke closed-loop system. Patients will be stratified into three groups according to baseline pain medication use:
- Patients with no strong opioids or anticonvulsants (control group, n≈10).
- Patients with monotherapy of strong opioids (n≈20).
- Patients with monotherapy of anticonvulsants (n≈20).
All participants will undergo a 3-week trial with one or two epidural leads (T7 level). If the trial is successful, patients will proceed to permanent implantation of the closed-loop stimulator. Assessments will occur at baseline, each week during the trial, at permanent implantation, and one month post-implantation.
Assessments
- Documentation of medication use (daily/weekly via Belgian Pain Platform [BPP] and clinical verification).
- Pain intensity (VAS), sleep, and activity (BPP).
- Activation plots (relationship between current output and ECAP amplitude anchored by patient-reported thresholds and maximum tolerable perception).
- Neurophysiological parameters: conduction velocity, chronaxie, rheobase.
Endpoints
- Primary endpoint: Effect of pain medication group on changes in spinal cord sensitivity to stimulation during the SCS trial, assessed through activation plots and medication intake.
- Secondary endpoints:
- Change in pain intensity (VAS) from baseline to post-trial.
- Reduction in pain medication intake during the trial and one month after implantation.
- Changes in sleep and activity.
- Additional neurophysiological outcomes (conduction velocity, chronaxie, rheobase).
Duration of Participation Each patient will participate from baseline assessment through 1 month after permanent implantation. Study exit occurs either at completion or upon withdrawal (e.g., unsuccessful trial phase or medical reasons).
Burden and Risks The primary and secondary endpoints involve assessments routinely performed in SCS trials. Additional neurophysiological measurements (conduction velocity, chronaxie, rheobase) may add 5-10 minutes to a follow-up visit. Risks are limited to those normally associated with SCS implantation. There is no direct benefit to participants, but data may inform future research and optimization of medication management during SCS therapy.
- Conditions
- Persistent Spinal Pain Syndrome Type 2 (PSPS-T2), Lower Spine, Spinal Cord Sensitivity to Neurostimulation, Neurophysiological Sensitivity to Spinal Cord Stimulation
- Being tested
- Spinal Cord Stimulation with Evoke Closed-Loop System
- Keywords
- Spinal cord stimulation, Closed-loop stimulation, Evoked Compound Action Potentials (ECAPs), Neurophysiology, Pain medication tapering, Opioids, Anticonvulsants, Neuromodulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord Stimulation with Evoke Closed-Loop SystemOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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). Receives: Other: Spinal Cord Stimulation with Evoke Closed-Loop System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Participants will be required report their pain intensity using a 10 cm visual analog scale (VAS) where 0 refers to no pain at all and 10 refers to worst possible pain. The resultant VAS score, expressed in cm, will be compared across study visits.
Measured: 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
Reduction in analgesic medication dose (standardized daily dose or milligram equivalents, if applicable) will be documented using daily/weekly BPP entries and verified by clinical staff. Data will be compared between baseline, end of SCS trial, and 1 month after permanent implantation.
Measured: 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.
The following neurophysiological parameters will be measured using the Evoke system's neurophysiological assessment tools.
- Conduction velocity (meter/sec): Changes in SCS neural conduction velocity (m/sec) will be compared across baseline, during the SCS trial phase, and 1 month after permanent implantation.
- Rheobase (mA): This is the lowest electrical current amplitude (mA) that can stimulate a nerve or muscle. Changes in rheobase will be compared across baseline, during the SCS trial phase, and 1 month after permanent implantation.
- Chronaxie (µs): The minimum pulse duration (µs) needed to excite a nerve or muscle when the current strength is set to double the rheobase. Changes in chronaxie will be compared across baseline, during the SCS trial phase, and 1 month after permanent implantation.
Measured: From start of SCS trial (baseline) to 1 month after permanent implantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start3 Feb 2025
- Primary completion3 Feb 2027 (estimated)
- Study completion3 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Persistent Spinal Pain Syndrome Type 2 (PSPS-T2), Lower SpineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brai²n
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Tony Van Havenbergh, Brai²n
- Investigators
- Tony Van Havenbergh, MD, Principal investigator, Brai²n / Department of Neurosurgery, ZAS Augustinus, Antwerp, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413731
- Sponsor's protocol ID
- Multicentric-ZAS-ECAP-01
- Status last verified
- Feb 2026
- First submitted
- 1 Sep 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The international committee of medical journal editors believes there is an ethical obligtion to share data generated by interventional clinical trials. This is not considered an interventional clinical trial
Publications
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.
PubMed 39133680Nissen 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.
PubMed 33073907
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Neurophysiological Effects of Medication Tapering During Treatment With ECAP Controlled Closed-loop Spinal Cord Stimulation Trial Periods
- ClinicalTrials.gov ID
- NCT07413731
- Acronym / sponsor ID
- Multicentric-ZAS-ECAP-01
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Brai²nUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 3 Feb 2027 (estimated)
- Study completion
- 3 Apr 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic neuropathic pain, particularly in patients with Persistent Spinal Pain Syndrome Type 2 (PSPS-T2, formerly FBSS), remains a major therapeutic challenge. Spinal cord stimulation (SCS) is an established therapy for patients with refractory pain. In Belgium, a 21-day trial period with an externalized epidural lead is mandatory before permanent implantation. During this trial, pain relief, improved sleep, increased activity, and reduction in pain medication intake must be documented in order to qualify for a permanent implant.
The Evoke™ Closed-Loop SCS system (Saluda Medical) is a CE-marked device used within its licensed indication in this study. This system uniquely records Evoked Compound Action Potentials (ECAPs) from the spinal cord, allowing continuous monitoring of neural activation. Closed-loop algorithms adjust stimulation output in real time based on measured ECAPs, thereby aiming to deliver consistent therapy within each patient's therapeutic window.
Recent pilot data and case reports have suggested that reductions in pain medication, particularly strong opioids and anticonvulsants, may alter spinal cord sensitivity to stimulation and ECAP parameters. A prospective pilot study performed at ZAS St. Augustinus Hospital (Belgium) demonstrated measurable changes in spinal cord sensitivity after medication reduction in patients implanted with the Evoke system. These findings suggest that medication tapering may influence neurophysiological responsiveness to SCS and highlight the importance of documenting this relationship systematically.
Study Design
This is a multicenter, open-label, prospective observational study enrolling 50 patients scheduled for SCS with the Evoke closed-loop system. Patients will be stratified into three groups according to baseline pain medication use:
- Patients with no strong opioids or anticonvulsants (control group, n≈10).
- Patients with monotherapy of strong opioids (n≈20).
- Patients with monotherapy of anticonvulsants (n≈20).
All participants will undergo a 3-week trial with one or two epidural leads (T7 level). If the trial is successful, patients will proceed to permanent implantation of the closed-loop stimulator. Assessments will occur at baseline, each week during the trial, at permanent implantation, and one month post-implantation.
Assessments
- Documentation of medication use (daily/weekly via Belgian Pain Platform [BPP] and clinical verification).
- Pain intensity (VAS), sleep, and activity (BPP).
- Activation plots (relationship between current output and ECAP amplitude anchored by patient-reported thresholds and maximum tolerable perception).
- Neurophysiological parameters: conduction velocity, chronaxie, rheobase.
Endpoints
- Primary endpoint: Effect of pain medication group on changes in spinal cord sensitivity to stimulation during the SCS trial, assessed through activation plots and medication intake.
- Secondary endpoints:
- Change in pain intensity (VAS) from baseline to post-trial.
- Reduction in pain medication intake during the trial and one month after implantation.
- Changes in sleep and activity.
- Additional neurophysiological outcomes (conduction velocity, chronaxie, rheobase).
Duration of Participation Each patient will participate from baseline assessment through 1 month after permanent implantation. Study exit occurs either at completion or upon withdrawal (e.g., unsuccessful trial phase or medical reasons).
Burden and Risks The primary and secondary endpoints involve assessments routinely performed in SCS trials. Additional neurophysiological measurements (conduction velocity, chronaxie, rheobase) may add 5-10 minutes to a follow-up visit. Risks are limited to those normally associated with SCS implantation. There is no direct benefit to participants, but data may inform future research and optimization of medication management during SCS therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Without strong opioids or anticonvulsants or other analgesic drugs | – | Other: Spinal Cord Stimulation with Evoke Closed-Loop SystemPatients with Persistent Spinal Pain Syndrome Type 2 (PSPS-T2) (lower spine) who are not taking any analgesic medication. |
| Monotherapy with strong opioids | – | Other: Spinal Cord Stimulation with Evoke Closed-Loop SystemPatients 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 | – | Other: Spinal Cord Stimulation with Evoke Closed-Loop SystemPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Belgian patients selected for spinal cord stimulation (SCS) with Persistent Spinal Pain Syndrome Type 2 (lower spine).
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Cord Stimulation with Evoke Closed-Loop SystemAll 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). | Other | Monotherapy with anticonvulsants, Monotherapy with strong opioids, Without strong opioids or anticonvulsants or other analgesic drugs |
Primary outcome
Spinal cord sensitivity expressed in ECAP amplitude (µV) as a function of the SCS stimulation amplitude (mA).
Time frame: From start of SCS trial (baseline) to 1 month after permanent implantation.
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.
3 secondary outcomes
Change in pain intensity measured using a 10 cm Visual Analog Scale (VAS)
Time frame: 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
Time frame: 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.
Time frame: From start of SCS trial (baseline) to 1 month after permanent implantation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Background: PubMed 39133680Moens 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.
- Background: PubMed 33073907Nissen 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.
- Individual participant dataSharing planned: No. The international committee of medical journal editors believes there is an ethical obligtion to share data generated by interventional clinical trials. This is not considered an interventional clinical trial
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tony Van Havenbergh, MD principal investigator
Brai²n / Department of Neurosurgery, ZAS Augustinus, Antwerp, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent Spinal Pain Syndrome Type 2 (PSPS-T2), Lower Spine and Spinal Cord Sensitivity to Neurostimulation, run by Brai²n at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pieter Van Looy (+32 3 443 48 72, pieter.vanlooy@zas.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal cord sensitivity expressed in ECAP amplitude (µV) as a function of the SCS stimulation amplitude (mA). (time frame: From start of SCS trial (baseline) to 1 month after permanent implantation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07413731, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.