Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT05708729

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

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-01

32

Participants Needed

1

Research Sites

166 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide voluntary written informed consent prior to any screening procedures
  • Male or female patients
  • Aged 18 to 70 years
  • Diagnosed with definite central post-stroke pain (CPSP) that is resistant to medications such as amitriptyline, lamotrigine, and pregabalin
Not Eligible

You will not qualify if you...

  • Aphasia
  • Pregnancy or intention to become pregnant within the next year
  • Medically unfit for surgery
  • Unable to temporarily stop anticoagulation or anti-platelet medications
  • Unable to undergo MRI, fMRI, or PET imaging
  • Complete destruction of the stimulation target area (motor cortex or sensory thalamus)
  • Uncontrolled seizures
  • Expected to relocate within the next year

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UZ Leuven

Leuven, Belgium, 3000

Actively Recruiting

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Research Team

P

Philippe De Vloo, prof. dr.

CONTACT

D

Daan Remans

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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