Central Post-stroke PainNCT05708729
Neuromodulation for Central Post-stroke Pain: Mechanism, Safety and Outcome
A study testing MCS surgery for CPSP and Vc-DBS surgery for CPSP in people with Central Post-stroke Pain and CPSP, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Central post-stroke pain (CPSP) is an often pharmacorefractory type of neuropathic pain that develops in 8% of stroke patients. CPSP has been treated with three distinct types of neuromodulation (deep brain stimulation of the sensory thalamus (Vc-DBS), motor cortex repetitive transcranial magnetic stimulation… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Central Post-stroke Pain, CPSP
- What is being tested?
- MCS surgery for CPSP and Vc-DBS surgery for CPSP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Jan 2023to Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide voluntary written informed consent of the participant prior to any screening procedures
- Male or female patients
- Aged 18-70 years
- Diagnosed with definite CPSP (Treede-Klit criteria) (1, 9), which is pharmacorefractory (i.e. amitriptyline 75mg/d 4w, lamotrigine 200mg/d 8w and pregabalin 600mg/d resulting in <50% VAS reduction and/or intolerable side-effects)
Who cannot join
- Aphasia
- Pregnancy or intention to become pregnant in the following year
- Medical inoperability
- Impossibility to temporarily withhold anticoagulation or anti-platelet medication
- Impossibility to undergo MRI, fMRI and/or PET imaging
- Complete destruction of the stimulation target region (M1 or Vc)
- Uncontrolled seizures
- Expected relocation in the following year.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Philippe De Vloo, prof.dr., 016 344290, neurochirurgie@uzleuven.be
About this study
Central post-stroke pain (CPSP) is an often pharmacorefractory type of neuropathic pain that develops in 8% of stroke patients. CPSP has been treated with three distinct types of neuromodulation (deep brain stimulation of the sensory thalamus (Vc-DBS), motor cortex repetitive transcranial magnetic stimulation (M1-rTMS), and motor cortex stimulation (MCS)), but the level of evidence for these procedures is very low. Moreover, data on the changes in pain brain circuitry in CPSP, and the effect of neuromodulation on this circuitry is very limited.
Read the detailed description
In this project, we propose a prospective double-blind randomized crossover on/off study in 32 CPSP patients. These patients will undergo M1-rTMS and either MCS or Vc-DBS. Before and after active and inactive stimulation they will be assessed with clinical scales for pain, function, quality of life and depression. Adverse events will be monitored. This allows to measure the outcome and safety of neuromodulation in CPSP.
In addition, we will have functional magnetic resonance imaging (fMRI) and positron emission tomography (PET) use. This will provide insight into the pathological changes in the pain circuitry, and the influence of neuromodulation.
- Conditions
- Central Post-stroke Pain, CPSP
- Being tested
- MCS surgery for CPSP, Vc-DBS surgery for CPSP
- Keywords
- neuromodulation, DBS, rTMS, MCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCS surgery for CPSPDevice
The investigational devices that will be used for the MCS surgeries are the following: the Vanta with AdaptiveStim Technology Primary cell neurostimulator or the Intellis Implantable Neurostimulator with AdaptiveStim Technology from Medtronic, Inc. (MN, USA). These implantable neurostimulators are intended to generate electrical pulses and to deliver stimulation trough one or more leads as part of a neurostimulation system for pain therapy in adults.
Vc-DBS surgery for CPSPDevice
For the deep brain stimulation procedure, we will use Vercise stimulators from Boston Scientific together with the Cartesia Directional Leads or the Percept PC stimulator from Medtronic.
| Study group | Role | What they receive |
|---|---|---|
| Patients with CPSP which is pharmacorefractory and have a good analgesic response to M1-rTMS | Experimental | Diagnosed with definite CPSP (Treede-Klit criteria), which is pharmacorefractory (i.e. amitriptyline 75mg/d 4w, lamotrigine 200mg/d 8w and pregabalin 600mg/d resulting in <50% VAS reduction and/or intolerable side-effects).
A good analgesic response to M1-rTMS is defined as: ≥50% mean 10-d VAS reduction immediately following vs. before active M1-rTMS minus mean 10-d VAS reduction immediately following vs. pre sham M1-rTMS. A good analgesic response gives a high positive predictive value for pain reduction by MCS. Receives: Device: MCS surgery for CPSP |
| Patients with CPSP which is pharmacorefractory with less analgesic M1-rTMS response | Experimental | Diagnosed with definite CPSP (Treede-Klit criteria), which is pharmacorefractory (i.e. amitriptyline 75mg/d 4w, lamotrigine 200mg/d 8w and pregabalin 600mg/d resulting in <50% VAS reduction and/or intolerable side-effects).
Patients with less analgesic M1-rTMS response (n≈20) will be 1:1 randomized to either MCS (≈10) or Vc-DBS (n≈10). Receives: Device: MCS surgery for CPSP; Device: Vc-DBS surgery for CPSP |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relative difference in pain intensity (Visual Analogue Scale; VAS) immediately following 10 sessions of active vs. inactive rTMS;
The patients will receive 10 sessions (1/d) of active and 10 sessions (1/d) of sham M1-rTMS with a 8-week wash-out period in between.
Measured: After completion of all rTMS sessions (approximately one month before surgery)
The relative difference in pain intensity (Visual Analogue Scale; VAS) immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS.
Stimulation will be optimised for all patients up to 5 months post-surgery (Vc-DBS or MCS). After 2 weeks of wash-out, active and inactive stimulation will be offered in a double-blinded fashion for 4 weeks, with 2 weeks of wash-out in between.
Measured: After completion of the 4 weeks of active vs. inactive MCS or Vc-DBS (approximately at 9 months after surgery)
Secondary outcomes (24)
The relative difference in pain symptoms* immediately following 10 sessions of active vs. inactive rTMS;
- as measured through the Neuropathic Pain Symptom Inventory (NPSI) and Patient Global Impression of Change (PGIC)
Measured: Immediately after completion of the 10 sessions of active (1 per day, on 10 consecutive days) and 10 sessions of sham (1 per day, on 10 consecutive days) M1-rTMS with a 8 weeks washout period inbetween
The relative difference in use of analgesics* immediately following 10 sessions of active vs. inactive rTMS;
- as measured through the Medication Quantification Scale
Measured: Immediately after completion of the 10 sessions of active (1 per day, on 10 consecutive days) and 10 sessions of sham (1 per day, on 10 consecutive days) M1-rTMS with a 8 weeks washout period inbetween
The relative difference in functionality* immediately following 10 sessions of active vs. inactive rTMS;
- as measured through the Functional Independence Measure (FIM)
Measured: Immediately after completion of the 10 sessions of active (1 per day, on 10 consecutive days) and 10 sessions of sham (1 per day, on 10 consecutive days) M1-rTMS with a 8 weeks washout period inbetween
The relative difference in quality of life* immediately following 10 sessions of active vs. inactive rTMS;
- as measured through the 36-Item Short-Form Health Survey (SF-36 QoLS)
Measured: Immediately after completion of the 10 sessions of active (1 per day, on 10 consecutive days) and 10 sessions of sham (1 per day, on 10 consecutive days) M1-rTMS with a 8 weeks washout period inbetween
The relative difference in mood* immediately following 10 sessions of active vs. inactive rTMS;
- as measured through the Beck Depression Inventory (BDI)
Measured: Immediately after completion of the 10 sessions of active (1 per day, on 10 consecutive days) and 10 sessions of sham (1 per day, on 10 consecutive days) M1-rTMS with a 8 weeks washout period inbetween
The relative difference in pain symptoms* immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
- as measured through the Neuropathic Pain Symptom Inventory (NPSI) and Patient Global Impression of Change (PGIC)
Measured: immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
The relative difference in use of analgesics* immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
- as measured through the Medication Quantification Scale
Measured: immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
The relative difference in functionality* immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
- as measured through the Functional Independence Measure (FIM)
Measured: immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
The relative difference in quality of life* immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
- as measured through the 36-Item Short-Form Health Survey (SF-36 QoLS)
Measured: immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
The relative difference in mood* immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
- as measured through the Beck Depression Inventory (BDI)
Measured: immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
The relative difference in metabolic activity (as measured through FDG-PET) in pain matrix areas immediately following 10 sessions of active vs. inactive rTMS;
Measured: Immediately after completion of the 10 sessions of active (1 per day, on 10 consecutive days) and 10 sessions of sham (1 per day, on 10 consecutive days) M1-rTMS with a 8 weeks washout period inbetween
The relative difference in metabolic activity (as measured through rsMRI) in pain matrix areas immediately following 10 sessions of active vs. inactive rTMS;
Measured: Immediately after completion of the 10 sessions of active (1 per day, on 10 consecutive days) and 10 sessions of sham (1 per day, on 10 consecutive days) M1-rTMS with a 8 weeks washout period inbetween
The relative difference in metabolic activity (as measured through FDG-PET) in pain matrix areas immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
Measured: immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
The relative difference in metabolic activity (as measured through rsMRI) in pain matrix areas immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
Measured: immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
The spike rate in the presence or absence of noxious/innocuous sensory stimuli (selected through baseline QSM);
*as measured through the microelectrodes (Vc-DBS) and paddle electrodes (MCS)
Measured: Intraoperative
The spectral power* in the presence or absence of noxious/innocuous sensory stimuli (selected through baseline QSM);
*as measured through the microelectrodes (Vc-DBS) and paddle electrodes (MCS)
Measured: Intraoperative
Other neurophysiological parameters* in the presence or absence of noxious/innocuous sensory stimuli (selected through baseline QSM);
*as measured through the microelectrodes (Vc-DBS) and paddle electrodes (MCS)
Measured: Intraoperative
The spike rate* in the presence and absence of noxious and innocuous sensory stimuli (selected through baseline QSM)
*as measured postoperatively through the implanted electrodes
Measured: following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
The spectral power* in the presence and absence of noxious and innocuous sensory stimuli (selected through baseline QSM)
*as measured postoperatively through the implanted electrodes
Measured: following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
Other neurophysiological parameters* in the presence and absence of noxious and innocuous sensory stimuli (selected through baseline QSM)
*as measured postoperatively through the implanted electrodes
Measured: following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
The safety for every procedure and during active and inactive rTMS, MCS and/or Vc-DBS.
*as measured by the AEs and SAEs
Measured: during procedure and during active and inactive rTMS, MCS and/or Vc-DBS.
The safety for every procedure
*as measured by the AEs and SAEs
Measured: during procedure
The safety during active and inactive rTMS
*as measured by the AEs and SAEs
Measured: during active and inactive rTMS
The safety during active and inactive MCS or Vc-DBS.
*as measured by the AEs and SAEs
Measured: during active and inactive MCS or Vc-DBS.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start24 Jan 2023
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Post-stroke PainStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708729
- Sponsor's protocol ID
- S66772
- Other IDs
- CIV-22-09-040829
- Status last verified
- Jun 2024
- First submitted
- 9 Jan 2023
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation for Central Post-stroke Pain: Mechanism, Safety and Outcome
- ClinicalTrials.gov ID
- NCT05708729
- Acronym / sponsor ID
- S66772
- Conditions
- Central Post-stroke Pain, CPSP
- Keywords
- neuromodulation, DBS, rTMS, MCS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 1 Feb 2023 (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.
Central post-stroke pain (CPSP) is an often pharmacorefractory type of neuropathic pain that develops in 8% of stroke patients. CPSP has been treated with three distinct types of neuromodulation (deep brain stimulation of the sensory thalamus (Vc-DBS), motor cortex repetitive transcranial magnetic stimulation (M1-rTMS), and motor cortex stimulation (MCS)), but the level of evidence for these procedures is very low. Moreover, data on the changes in pain brain circuitry in CPSP, and the effect of neuromodulation on this circuitry is very limited.
Detailed description
In this project, we propose a prospective double-blind randomized crossover on/off study in 32 CPSP patients. These patients will undergo M1-rTMS and either MCS or Vc-DBS. Before and after active and inactive stimulation they will be assessed with clinical scales for pain, function, quality of life and depression. Adverse events will be monitored. This allows to measure the outcome and safety of neuromodulation in CPSP.
In addition, we will have functional magnetic resonance imaging (fMRI) and positron emission tomography (PET) use. This will provide insight into the pathological changes in the pain circuitry, and the influence of neuromodulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with CPSP which is pharmacorefractory and have a good analgesic response to M1-rTMS | Experimental | Device: MCS surgery for CPSPDiagnosed with definite CPSP (Treede-Klit criteria), which is pharmacorefractory (i.e. amitriptyline 75mg/d 4w, lamotrigine 200mg/d 8w and pregabalin 600mg/d resulting in <50% VAS reduction and/or intolerable side-effects). A good analgesic response to M1-rTMS is defined as: ≥50% mean 10-d VAS reduction immediately following vs. before active M1-rTMS minus mean 10-d VAS reduction immediately following vs. pre sham M1-rTMS. A good analgesic response gives a high positive predictive value for pain reduction by MCS. |
| Patients with CPSP which is pharmacorefractory with less analgesic M1-rTMS response | Experimental | Device: MCS surgery for CPSP, Device: Vc-DBS surgery for CPSPDiagnosed with definite CPSP (Treede-Klit criteria), which is pharmacorefractory (i.e. amitriptyline 75mg/d 4w, lamotrigine 200mg/d 8w and pregabalin 600mg/d resulting in <50% VAS reduction and/or intolerable side-effects). Patients with less analgesic M1-rTMS response (n≈20) will be 1:1 randomized to either MCS (≈10) or Vc-DBS (n≈10). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to provide voluntary written informed consent of the participant prior to any screening procedures
- Male or female patients
- Aged 18-70 years
- Diagnosed with definite CPSP (Treede-Klit criteria) (1, 9), which is pharmacorefractory (i.e. amitriptyline 75mg/d 4w, lamotrigine 200mg/d 8w and pregabalin 600mg/d resulting in <50% VAS reduction and/or intolerable side-effects)
Key exclusion criteria (8 listed)
- Aphasia
- Pregnancy or intention to become pregnant in the following year
- Medical inoperability
- Impossibility to temporarily withhold anticoagulation or anti-platelet medication
- Impossibility to undergo MRI, fMRI and/or PET imaging
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 |
|---|---|---|
| MCS surgery for CPSPThe investigational devices that will be used for the MCS surgeries are the following: the Vanta with AdaptiveStim Technology Primary cell neurostimulator or the Intellis Implantable Neurostimulator with AdaptiveStim Technology from Medtronic, Inc. (MN, USA). These implantable neurostimulators are intended to generate electrical pulses and to deliver stimulation trough one or more leads as part of a neurostimulation system for pain therapy in adults. | Device | Patients with CPSP which is pharmacorefractory and have a good analgesic response to M1-rTMS, Patients with CPSP which is pharmacorefractory with less analgesic M1-rTMS response |
| Vc-DBS surgery for CPSPFor the deep brain stimulation procedure, we will use Vercise stimulators from Boston Scientific together with the Cartesia Directional Leads or the Percept PC stimulator from Medtronic. | Device | Patients with CPSP which is pharmacorefractory with less analgesic M1-rTMS response |
Primary outcome
The relative difference in pain intensity (Visual Analogue Scale; VAS) immediately following 10 sessions of active vs. inactive rTMS;
Time frame: After completion of all rTMS sessions (approximately one month before surgery)
The patients will receive 10 sessions (1/d) of active and 10 sessions (1/d) of sham M1-rTMS with a 8-week wash-out period in between.
The relative difference in pain intensity (Visual Analogue Scale; VAS) immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS.
Time frame: After completion of the 4 weeks of active vs. inactive MCS or Vc-DBS (approximately at 9 months after surgery)
Stimulation will be optimised for all patients up to 5 months post-surgery (Vc-DBS or MCS). After 2 weeks of wash-out, active and inactive stimulation will be offered in a double-blinded fashion for 4 weeks, with 2 weeks of wash-out in between.
24 secondary outcomes
The relative difference in pain symptoms* immediately following 10 sessions of active vs. inactive rTMS;
Time frame: Immediately after completion of the 10 sessions of active (1 per day, on 10 consecutive days) and 10 sessions of sham (1 per day, on 10 consecutive days) M1-rTMS with a 8 weeks washout period inbetween
The relative difference in use of analgesics* immediately following 10 sessions of active vs. inactive rTMS;
Time frame: Immediately after completion of the 10 sessions of active (1 per day, on 10 consecutive days) and 10 sessions of sham (1 per day, on 10 consecutive days) M1-rTMS with a 8 weeks washout period inbetween
The relative difference in functionality* immediately following 10 sessions of active vs. inactive rTMS;
Time frame: Immediately after completion of the 10 sessions of active (1 per day, on 10 consecutive days) and 10 sessions of sham (1 per day, on 10 consecutive days) M1-rTMS with a 8 weeks washout period inbetween
The relative difference in quality of life* immediately following 10 sessions of active vs. inactive rTMS;
Time frame: Immediately after completion of the 10 sessions of active (1 per day, on 10 consecutive days) and 10 sessions of sham (1 per day, on 10 consecutive days) M1-rTMS with a 8 weeks washout period inbetween
The relative difference in mood* immediately following 10 sessions of active vs. inactive rTMS;
Time frame: Immediately after completion of the 10 sessions of active (1 per day, on 10 consecutive days) and 10 sessions of sham (1 per day, on 10 consecutive days) M1-rTMS with a 8 weeks washout period inbetween
The relative difference in pain symptoms* immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
Time frame: immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
The relative difference in use of analgesics* immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
Time frame: immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
The relative difference in functionality* immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
Time frame: immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
The relative difference in quality of life* immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
Time frame: immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
The relative difference in mood* immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
Time frame: immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
The relative difference in metabolic activity (as measured through FDG-PET) in pain matrix areas immediately following 10 sessions of active vs. inactive rTMS;
Time frame: Immediately after completion of the 10 sessions of active (1 per day, on 10 consecutive days) and 10 sessions of sham (1 per day, on 10 consecutive days) M1-rTMS with a 8 weeks washout period inbetween
The relative difference in metabolic activity (as measured through rsMRI) in pain matrix areas immediately following 10 sessions of active vs. inactive rTMS;
Time frame: Immediately after completion of the 10 sessions of active (1 per day, on 10 consecutive days) and 10 sessions of sham (1 per day, on 10 consecutive days) M1-rTMS with a 8 weeks washout period inbetween
The relative difference in metabolic activity (as measured through FDG-PET) in pain matrix areas immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
Time frame: immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
The relative difference in metabolic activity (as measured through rsMRI) in pain matrix areas immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
Time frame: immediately following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
The spike rate in the presence or absence of noxious/innocuous sensory stimuli (selected through baseline QSM);
Time frame: Intraoperative
The spectral power* in the presence or absence of noxious/innocuous sensory stimuli (selected through baseline QSM);
Time frame: Intraoperative
Other neurophysiological parameters* in the presence or absence of noxious/innocuous sensory stimuli (selected through baseline QSM);
Time frame: Intraoperative
The spike rate* in the presence and absence of noxious and innocuous sensory stimuli (selected through baseline QSM)
Time frame: following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
The spectral power* in the presence and absence of noxious and innocuous sensory stimuli (selected through baseline QSM)
Time frame: following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
Other neurophysiological parameters* in the presence and absence of noxious and innocuous sensory stimuli (selected through baseline QSM)
Time frame: following 4 weeks of active (with optimized stimulation parameters) vs. inactive MCS or Vc-DBS;
The safety for every procedure and during active and inactive rTMS, MCS and/or Vc-DBS.
Time frame: during procedure and during active and inactive rTMS, MCS and/or Vc-DBS.
The safety for every procedure
Time frame: during procedure
The safety during active and inactive rTMS
Time frame: during active and inactive rTMS
The safety during active and inactive MCS or Vc-DBS.
Time frame: during active and inactive MCS or Vc-DBS.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MCS surgery for CPSP and Vc-DBS surgery for CPSP in people with Central Post-stroke Pain and CPSP, run by Universitaire Ziekenhuizen KU Leuven 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 1 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe De Vloo, prof. dr. (016 344290, neurochirurgie@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relative difference in pain intensity (Visual Analogue Scale; VAS) immediately following 10 sessions of active vs. inactive rTMS; (time frame: After completion of all rTMS sessions (approximately one month before surgery)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2024.