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临床试验/NCT05335668
NCT05335668招募中不适用

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

Insel Gruppe AG, University Hospital Bern2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2022年7月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
88
试验地点
2
主要终点
Correlation between cerebral connectivity patterns

研究概览

简要总结

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.

详细描述

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 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.

The objective of this research project is to correlate clinical aspects of CPP (pain phenomenology) with magnetic resonance image (MRI)-based findings, especially metabolic changes and functional reorganization processes captured by functional MRI and MR spectroscopy. A better understanding of the underlying pathophysiological mechanism of CPP and its involved neuronal networks are mandatory for any future therapeutic approach to treat this difficult condition. The discovery of a potential image-based biomarker could serve to help identify patients early who are at risk of developing CPP. Furthermore, the findings may help identify prognosticators of different forms of CPP treatments (e.g. biofeed-back, neuromodulation approaches, medication) in the future.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.)

研究组 & 干预措施

Patients with central poststroke pain

Experimental

Patients with central poststroke pain

干预措施: Clinical Testing (Procedure)

Patients without central poststroke pain

Experimental

Patients without central poststroke pain

干预措施: Clinical Testing (Procedure)

healthy controls

Active Comparator

healthy volunteers

干预措施: Clinical Testing (Procedure)

结局指标

主要结局

Correlation between cerebral connectivity patterns

时间窗: Day 30 after inclusion

Correlation between cerebral connectivity patterns at rest during pain-processing tasks based on functional MRI

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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