Neuromodulation for Central Post-stroke Pain: Mechanism, Safety and Outcome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
Aphasia
Pregnancy or intention to become pregnant in the following year
Medical inoperability
Impossibility to temporarily withhold anticoagulation or anti-platelet medication
Trial design
Treatments tested in this trial
- MCS surgery for CPSP
- Vc-DBS surgery for CPSP
Treatment groups
32 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov