Stroke SequelaeAVCDNCT06813391
Prevalence of Central Neuropathic Pain After a Stroke in Patients Attending Post-stroke Consultations in the Île-de-France Region
An observational study of Stroke Sequelae and Neuropathic Pain, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Sequelae, Neuropathic Pain
- What is being tested?
- Patient Reported Outcome (PRO)
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2025to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Post Stroke Patient
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Paris Saint Joseph
Paris, France, 75014
Juliette COURTIADE MAHLER, PhD, +33144127963, jcourtiade@ghpsj.fr
About this study
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.
- Conditions
- Stroke Sequelae, Neuropathic Pain
- Being tested
- Patient Reported Outcome (PRO)
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Reported Outcome (PRO)Other
after enrollment, patient will answer to several PRO to assess their pain and overall well-being after their stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke SequelaeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813391
- Sponsor's protocol ID
- AVCD
- Acronym
- AVCD
- Status last verified
- Feb 2025
- First submitted
- 30 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Central Neuropathic Pain After a Stroke in Patients Attending Post-stroke Consultations in the Île-de-France Region
- ClinicalTrials.gov ID
- NCT06813391
- Acronym / sponsor ID
- AVCD / AVCD
- Conditions
- Stroke Sequelae, Neuropathic Pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post Stroke Patient
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Reported Outcome (PRO)after enrollment, patient will answer to several PRO to assess their pain and overall well-being after their stroke | Other | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke Sequelae and Neuropathic Pain, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marguerite D'USSEL, MD (+33144126180, mdussel@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Pain (time frame: enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.