RecruitingNot ApplicableNCT05335668

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

Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

88 participants

Start Date

Jul 18, 2022

Study Type

INTERVENTIONAL

Conditions

Pain CPP

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, no drug has proven efficient to alleviate CPP and neuromodulation approaches including Deep Brain Stimulation (DBS) and motor-cortex stimulation have yielded mixed results with only a few patients experiencing long-term pain relief. To date, little is known about the pathophysiology of CPP. There is at present little evidence for a clear association between the specific location of lesions, clinical manifestation and phenomenology of pain as well as treatment response of CPP patients. Furthermore, the time delay between stroke occurrence and CPP occurrence is highly variable and the fact, that it is not immediate in the great majority of patients suggests that other factors contribute to the development of CPP. These factors have not been identified yet.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

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
Informed consent as documented by signature
Age: ≥18 years and ≤ 75 years

Exclusion Criteria9

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
Pregnancy and breastfeeding
Contraindication for 7T MRI (metallic implant, tattoo, claustrophobia, etc.)

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Interventions

PROCEDUREClinical Testing

Clinical testing for neurological deficits based on National Institute of Health Stroke Scale (NIHSS), objective sensory testing and pain assessment by quantitative sensory testing (QST) and quantitative pain drawings, 7T magnetic resonance imaging (MRI)