Neuromodulation for Central Post-stroke Pain: Mechanism, Safety and Outcome
Universitaire Ziekenhuizen KU Leuven
32 participants
Jan 24, 2023
INTERVENTIONAL
Conditions
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 (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.
Eligibility
Inclusion Criteria4
- 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)
Exclusion Criteria8
- 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.
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Interventions
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05708729