Status:

RECRUITING

Brain Circuitry Changes in Central Poststroke Pain: a Clinical and Neuroimaging Study

Lead Sponsor:

Insel Gruppe AG, University Hospital Bern

Conditions:

CPP

Pain

Eligibility:

All Genders

18-75 years

Phase:

NA

Brief Summary

Central poststroke pain (CPP) is estimated to affect up to 10% of stroke patients and is one of the most difficult-to-treat conditions with a detrimental effect on patient's quality of life. So far, n...

Detailed Description

Central poststroke pain (CPP) is estimated to affect up to 10% of stroke patients and is one of the most difficult-to-treat conditions with a detrimental effect on patient's quality of life. So far, n...

Eligibility Criteria

Inclusion

  • Inclusion Criteria patients:
  • Patients with a haemorrhagic or ischemic stroke affecting the somatosensory system as defined by both CT or MRI and clinical criteria
  • Patient age between 18-75 years
  • Signed written informed consent
  • Exclusion Criteria patients:
  • Secondary stroke due to a cerebral vascular malformation or tumor
  • Patients with aphasic syndromes and impaired verbal communication, complete sensory-motor hemi-neglect and restrictions of the ability to report on their pain and cooperate during sensory testing
  • Patients with severe stroke NIHSS \> 14 and or Modified Rankin Scale (MRS) \> 3
  • History of severe myelopathy or polyneuropathy with clinical sensory deficits and history of neuropathic pain
  • Widespread stroke size due to internal carotid artery-occlusion or more than one main territory (anterior, middle or posterior cerebral artery)
  • Contraindication for 7T MRI (metallic implant, tattoo, claustrophobia, etc.)
  • In case of women \< 45 years of age: pregnancy
  • Inclusion Criteria for healthy volunteers
  • Informed consent as documented by signature
  • Age: ≥18 years and ≤ 75 years
  • Exclusion criteria for healthy volunteers
  • Pregnancy and breastfeeding
  • Contraindication for 7T MRI (metallic implant, tattoo, claustrophobia, etc.)

Exclusion

    Key Trial Info

    Start Date :

    July 18 2022

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    September 1 2025

    Estimated Enrollment :

    88 Patients enrolled

    Trial Details

    Trial ID

    NCT05335668

    Start Date

    July 18 2022

    End Date

    September 1 2025

    Last Update

    October 17 2024

    Active Locations (1)

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    1

    Dep. of Neurosurgery, Bern University Hospital

    Bern, Switzerland, 3000