NCT06813391

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Mar 2025Oct 2026

First Submitted

Initial submission to the registry

January 30, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 7, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

1 year

First QC Date

January 30, 2025

Last Update Submit

February 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Central Pain

    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

Interventions

after enrollment, patient will answer to several PRO to assess their pain and overall well-being after their stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Post Stroke Patient

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Paris Saint Joseph

Paris, France, 75014, France

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Care SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Services ResearchHealth PlanningHealth Care Economics and OrganizationsPatient Outcome AssessmentOutcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationHealth Care Evaluation MechanismsPublic HealthEnvironment and Public Health

Central Study Contacts

Marguerite D'USSEL, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2025

First Posted

February 7, 2025

Study Start

March 1, 2025

Primary Completion

March 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

February 7, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations