- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06813391
Prevalence of Central Neuropathic Pain After a Stroke in Patients Attending Post-stroke Consultations in the Île-de-France Region (AVCD)
Post-stroke pain is common, affecting 15-50% of patients and significantly impacting their quality of life, rehabilitation, and functional recovery. There are different types of post-stroke pain, including peripheral pain related to spasticity, shoulder pain, complex regional pain syndrome, and headaches, as well as central pain linked to brain lesions. Central Post-Stroke Pain (CPSP) is diagnosed when the pain has neuropathic characteristics (burning, cold, tightness, compression), possibly accompanied by allodynia, hyperesthesia, and sensory-motor disorders localized to the area affected by the stroke. CPSP disrupts sleep, impairs functional rehabilitation, and can lead to depression, anxiety, substance abuse, and cognitive disorders. The prevalence of CPSP varies, ranging from 1% to 35%, but it is likely underreported due to difficulties in detection caused by cognitive or communication issues, the clinical variability of CPSP, and its coexistence with other types of post-stroke pain.
CPSP often remains resistant to standard neuropathic pain treatments, such as anticonvulsants and antidepressants, which may cause side effects that reduce patients' autonomy and quality of life. Non-pharmacological therapies used in other chronic pain conditions may offer promising alternatives, but have not been widely studied in CPSP. Improved clinical characterization of CPSP patients is essential. Following a 2015 decree by the French Ministry of Health, post-stroke consultations are standardized, providing a good opportunity for systematic pain screening. The study proposes a systematic screening of different types of pain during post-stroke consultations, categorizing patients into three groups: those with CPSP, those with pain from another mechanism, and those without pain.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Marguerite D'USSEL, MD
- Phone Number: +33144126180
- Email: mdussel@ghpsj.fr
Study Locations
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Paris, France, 75014
- Hopital Paris Saint Joseph
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Contact:
- Juliette Courtiade Mahler, PhD
- Phone Number: +33144127963
- Email: jcourtiade@ghpsj.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient aged ≥18 years
- Patient attending a post-stroke consultation (3 to 6 months after the stroke)
- Stroke confirmed by imaging (MRI or CT scan)
- Francophone patient
- Patient not opposing participation in the study
Exclusion Criteria:
- Patient with cognitive or communication disorders preventing them from completing the questionnaires (as assessed by the investigator)
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under judicial protection
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Central Pain
Time Frame: enrollment
|
determine the prevalence of post-stroke central pain in patients recruited during post-stroke consultations conducted between 3 and 6 months after their stroke.
|
enrollment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AVCD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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