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

Last updated: June 28, 2024
Sponsor: Universitaire Ziekenhuizen KU Leuven
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

Vc-DBS surgery for CPSP

MCS surgery for CPSP

Clinical Study ID

NCT05708729
S66772
CIV-22-09-040829
  • Ages 18-70
  • All Genders

Study 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

Inclusion Criteria:

  1. Able to provide voluntary written informed consent of the participant prior to anyscreening procedures

  2. Male or female patients

  3. Aged 18-70 years

  4. Diagnosed with definite CPSP (Treede-Klit criteria) (1, 9), which ispharmacorefractory (i.e. amitriptyline 75mg/d 4w, lamotrigine 200mg/d 8w andpregabalin 600mg/d resulting in <50% VAS reduction and/or intolerable side-effects)

Exclusion

Exclusion Criteria:

  1. Aphasia

  2. Pregnancy or intention to become pregnant in the following year

  3. Medical inoperability

  4. Impossibility to temporarily withhold anticoagulation or anti-platelet medication

  5. Impossibility to undergo MRI, fMRI and/or PET imaging

  6. Complete destruction of the stimulation target region (M1 or Vc)

  7. Uncontrolled seizures

  8. Expected relocation in the following year.

Study Design

Total Participants: 32
Treatment Group(s): 2
Primary Treatment: Vc-DBS surgery for CPSP
Phase:
Study Start date:
January 24, 2023
Estimated Completion Date:
April 30, 2026

Study 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.

Connect with a study center

  • UZ Leuven

    Leuven, 3000
    Belgium

    Active - Recruiting

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