Investigating brain changes in patients with central poststroke pain
Brain Circuitry Changes in Central Poststroke Pain: a Clinical and Neuroimaging Study
This study is trying to see how brain changes relate to pain in people aged 18-75 who have had a stroke, to help improve diagnosis and treatment for central poststroke pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT05335668 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the relationship between clinical aspects of central poststroke pain (CPP) and neuroimaging findings using MRI techniques. It focuses on understanding the pathophysiology of CPP by examining metabolic changes and functional reorganization in the brain. By correlating pain phenomenology with MRI data, the research seeks to identify potential biomarkers that could aid in early diagnosis and treatment strategies for CPP. The study includes patients aged 18-75 who have experienced a stroke affecting the somatosensory system.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18-75 who have had a hemorrhagic or ischemic stroke affecting the somatosensory system.
Not a fit: Patients with severe strokes, significant communication impairments, or contraindications for MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved understanding and treatment options for patients suffering from central poststroke pain.
How similar studies have performed: While there have been mixed results in previous studies on neuromodulation for CPP, this approach focusing on neuroimaging and pathophysiology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.)
Where this trial is running
Bern
- Dep. of Neurosurgery, Bern University Hospital — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Claudio Pollo, MD — Inselspital Bern, Department of Neurosurgery
- Study coordinator: Andreas Nowacki, MD
- Email: andreas.nowacki@insel.ch
- Phone: +41316322409
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.