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Not Yet Recruiting NCT05708729

Neuromodulation for Central Post-stroke Pain: Mechanism, Safety and Outcome

Conditions: Central Post-stroke Pain, CPSP

Sex: All
Ages: 18 Years – 70 Years
Phase: NA
Enrollment: 32
Sponsor: Universitaire Ziekenhuizen KU Leuven

Location: Belgium

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 Criteria

Inclusion Criteria:Able to provide voluntary written informed consent of the participant prior to any screening proceduresMale or female patientsAged 18-70 yearsDiagnosed 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 Criteria:AphasiaPregnancy or intention to become pregnant in the following yearMedical inoperabilityImpossibility to temporarily withhold anticoagulation or anti-platelet medicationImpossibility to undergo MRI, fMRI and/or PET imagingComplete destruction of the stimulation target region (M1 or Vc)Uncontrolled seizuresExpected relocation in the following year.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05708729). StuddyBuddy aggregates publicly available trial information.