Post Stroke EpilepsyIPSERRNCT06108102
International Post-Stroke Epilepsy Research Repository
An observational study of Post Stroke Epilepsy and Post Stroke Seizure, run by Yale University at 1 site in United States.
Trial summary
The International Post-Stroke Epilepsy Research Repository (IPSERR): The study aims to collate and categorize data reported by post-stroke epilepsy (PSE) researchers and lodge it within the IPSERR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Stroke Epilepsy, Post Stroke Seizure, Stroke
- What is being tested?
- Presence of stroke, either ischemic or hemorrhagic (intracerebral and subarachnoid)
- How many people
- 8,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to Dec 2029
- How long will I take part?
- 5 Years
- 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: Patients with stroke aged ≥18 years, with ischemic or hemorrhagic stroke, presenting with early or late post-stroke seizures. Patients presenting ≤1 week will be classified as early seizures and >1 week will be classified as late seizures.
Who may be able to join
- Studies with minimum dataset of 100 patients
- Studies comprising stroke patients aged ≥18 years, with ischemic or hemorrhagic stroke, presenting early or late PSS with data on patient outcome measures.
- Documented consent or waiver of consent following local Institutional Review Board-approved procedure.
- Studies published on human subjects.
- No restriction based on the date or language of publication, gender, or ethnicity.
Who cannot join
- Studies of patients with a prior history of seizures before the index stroke,
- Studies that did not report outcome data, or are not able to share IPD.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: International Post Stroke Epilepsy Research Repository to Characterize Post-stroke Epilepsy Population and Their Outcomes
The International Post-Stroke Epilepsy Research Repository (IPSERR): The study aims to collate and categorize data reported by post-stroke epilepsy (PSE) researchers and lodge it within the IPSERR. Using the IPSERR database, we will conduct two individual patient data (IPD) analyses: (1) determine epilepsy, functional, and cognitive outcomes in stroke patients who develop post-stroke seizure and (2) build and validate post-stroke epilepsy prediction model and compare performance against existing models.
Read the detailed description
The cerebrovascular disease is the most common cause of late-onset epilepsy. PSE is associated with increased morbidity, including cognitive decline, dependence, and poor quality of life, and is a critical determinant factor of stroke prognosis. We recently reported a systematic review and meta-analysis of 71 papers that suggested that post-stroke seizures are associated with more significant mortality and poor functional and cognitive outcomes (PMID:37721736). In this study, we observed disparate methods used by the individual investigators. We also noted variations in study reporting. PI aims to analyze existing individual patient data, including those analyzed in the systematic review, by collaborating with colleagues in the field and developing IPSERR into a resource for future collaborative studies that will tackle anti-epileptogenesis drug trial design.
Design and Rationale:
- International Post-Stroke Epilepsy Research Repository (IPSERR): The PI convened the International Post-Stroke Epilepsy Research Consortium (IPSERC) with co-convenor Dr. Patrick Kwan, Monash University, Australia. IPSERR was subsequently founded to collect retrospective and prospective PSE data to promote all aspects of PSE research. Participating centers will obtain legal approvals for human subject research as per the requirements of their jurisdiction. The PI (NKM) has IRB approval for IPSERR. A data use agreement (DUA) will be executed to receive data. The PI will invite the authors of all 71 papers in the systematic review to join IPSERC and request them to contribute data to IPSERR. A protocol (including the charter) for the proposed IPD analyses has been accepted for publication and will be available to the collaborators for review.
- The PI will use the Yale Center for Research Computing (YCRC) resources to manage IPSERR's clinical, radiological, and electrophysiological data.
- The PI will use Redcap for clinical data management. The Redcap server is housed within the Yale-New Haven Hospital secured data center behind their firewall. The databases are encrypted at rest for HIPAA compliance. Full database backups are made twice daily, seven days a week.
- Study duration: 2023-2029
- Rationale: Collaboration is vital for PSE research. This is because approximately 10% of stroke patients develop PSE. Together, investigators can collect a large sample of the PSE patient population and conduct robust analyses to draw meaningful conclusions. The collation of IPD from many different sources involving different interventions and stroke subpopulations will strengthen our ability to provide data for future research on many topics relating to PSE. The availability of high-speed internet has made it easier than ever to work closely with colleagues worldwide and share data. There are many examples of such successful efforts. For example, PI Dr. Mishra closely worked with the SITS-ISTR registry at Karolinska University, Stockholm, and the Virtual Stroke Trials Archive (VISTA) at the University of Glasgow, UK. These two international efforts recorded tPA and stroke trial data, respectively, and provided them for testing several hypotheses. Dr. Mishra subsequently worked at the US FDA, where he was exposed to other large collaborative scientific efforts like MDEpiNET. The PI seeks to capitalize on his experiences, network of colleagues worldwide, and recent technological advancement in data science to build the IPSERR. We anticipate that the IPSERR will bring together large datasets from previously conducted PSE research that would otherwise ordinarily remain dormant. The PI will request data from the authors of papers included in the systematic review (N=71 papers reporting approximately 20000 PSE patient data) and from the IPSERC members. The PI will report IPSERR in the first year and the results of the two research projects anchored on it in the second year. The PI will recognize that not all authors of the previously published literature in our systematic review will have data to share. However, even if 20% of the patient data is obtained from those studies, the PI expects an extensive database of approximately 8000 patients. With this success, the PI expects the IPSERR to continue growing. IPSERR will catalytically advance PSE research because it will provide the PSE research community with an extensive database for hypotheses testing and a framework to anchor future prospective studies.
- Conditions
- Post Stroke Epilepsy, Post Stroke Seizure, Stroke, Epilepsy
- Being tested
- Presence of stroke, either ischemic or hemorrhagic (intracerebral and subarachnoid)
- Keywords
- Post-stroke epilepsy, Clinical outcomes, Prognosis, Individual patient data
- Medical subject headings
- Stroke, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Presence of stroke, either ischemic or hemorrhagic (intracerebral and subarachnoid)Other
Presence of ischemic or hemorrhagic stroke confirmed by neuroimaging and clinical diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Post-stroke epilepsy | Stroke patients aged ≥18 years, with ischemic or hemorrhagic stroke, presenting with early or late onset post-stroke seizures. Receives: Other: Presence of stroke, either ischemic or hemorrhagic (intracerebral and subarachnoid) | |
| No post-stroke epilepsy | Stroke patients aged ≥18 years, with ischemic or hemorrhagic stroke, presenting with no post-stroke seizures. Receives: Other: Presence of stroke, either ischemic or hemorrhagic (intracerebral and subarachnoid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality (modified Rankin Scale = 6)
The modified Rankin Scale (mRS) is a clinician-reported measure of global disability for evaluating recovery from stroke. It ranges from 0 (no symptoms) to 6 (death).
Measured: At 1 year, 2 year, and 5 year follow-up
Poor functional outcome (modified Rankin Scale 3-6)
The modified Rankin Scale (mRS) is a clinician-reported measure of global disability for evaluating recovery from stroke. It ranges from 0 (no symptoms) to 6 (death), with 0-2 indicating a good functional outcome and 3-6 indicating a poor functional outcome.
Measured: At 1 year, 2 year, and 5 year follow-up
Seizure frequency
Number of seizures post-stroke identified clinically or based on an electroencephalogram (EEG).
Measured: At 1 year, 2 year, and 5 year follow-up
Seizure severity
Defined by impaired awareness and the presence of bilateral tonic or clonic seizures.
Measured: At 1 year, 2 year, and 5 year follow-up
Occurrence or frequency of status epilepticus
Status epilepticus is defined as a seizure or series of seizures lasting more than 30 minutes without recovery of consciousness based on electroencephalogram (EEG) findings.
Measured: At 1 year, 2 year, and 5 year follow-up
Length of hospital stay
The duration of hospital admission for a stroke is measured in days.
Measured: At 1 year, 2 year, and 5 year follow-up
Cognitive decline assessed on an 11-question Mini-Mental State Examination (MMSE) tool or a 30-point Montreal Cognitive Assessment (MoCA) scale
MMSE is tests cognitive function. It is scored out of 30, with a score of ≤26 indicating cognitive impairment. MoCA assesses mild cognitive dysfunction. It is scored out of 30, with a score of ≤24 indicating cognitive impairment.
Measured: At 1 year, 2 year, and 5 year follow-up
Secondary outcomes (5)
Recurrent stroke
A diagnosis of a subsequent stroke will be made based on neuroimaging.
Measured: At 1 year, 2 year, and 5 year follow-up
Antiseizure medication discontinuation
Switching of antiseizure medication (ASM) defined as discontinuation of one ASM and starting of another due to adverse events or treatment ineffectiveness.
Measured: At 1 year, 2 year, and 5 year follow-up
Treatment adverse events
Adverse events are defined as any side effects occurring due to antiseizure medication administration during the course of the study.
Measured: At 1 year, 2 year, and 5 year follow-up
Depression assessed on 21-item Hamilton Depression Rating Scale (HAM-D)
HAM-D is a tool used to assess depression symptoms. Depression post-ASM administration is defined as HAM-D score of 0-13 mild; 14-17 mild to moderate; >17 moderate to severe depression.
Measured: At 1 year, 2 year, and 5 year follow-up
Anxiety assessed on 14-item Hamilton Anxiety Rating Scale (HAM-A)
HAM-A is a psychological questionnaire that measures the severity of a patient's anxiety. Anxiety post-ASM administration is defined as HAM-A score of <17 mild; 18-24 moderate; 25-30 moderate to severe anxiety.
Measured: At 1 year, 2 year, and 5 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Mar 2024
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Stroke EpilepsyStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University
- Responsible party
- Sponsor
- Investigators
- Nishant K Mishra, MD PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108102
- Sponsor's protocol ID
- 2000032731
- Other IDs
- No NIH funding
- Acronym
- IPSERR
- Status last verified
- Oct 2025
- First submitted
- 24 Oct 2023
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The PI (NKM) will create a centralized database, collect, and analyze PSE patient data, and establish common data protocols. IPSERR welcomes all PSE researchers as impartial members, granting membership to institutions. Each organization will have a role in the IPSERR steering committee. One named individual, usually the principal investigator of the contributing study, will represent the institution in the IPSERR. Steering committee members will review and approve research proposals. To address data concerns like confidentiality, reliability, and authorship, strict guidelines will be set for handling patient data, promoting ethical data sharing and collaborators' involvement in publications. Data will be securely stored, and access will be restricted to authorized individuals. The IPSERR constitution will define eligibility, data protection, storage, compatibility, and documentation.
Publications
Mishra NK, Kwan P, Tanaka T, Sunnerhagen KS, Dawson J, Zhao Y, Misra S, Wang S, Sharma VK, Mazumder R, Funaro MC, Ihara M, Nicolo JP, Liebeskind DS, Yasuda CL, Cendes F, Quinn TJ, Ge Z, Scalzo F, Zelano J, Kasner SE; International Post-Stroke Epilepsy Research Consortium (IPSERC); International Post Stroke Epilepsy Research Consortium (IPSERC). Clinical characteristics and outcomes of patients with post-stroke epilepsy: protocol for an individual patient data meta-analysis from the International Post-stroke Epilepsy Research Repository (IPSERR). BMJ Open. 2023 Nov 15;13(11):e078684. doi: 10.1136/bmjopen-2023-078684.
PubMed 37968000
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Post Stroke Epilepsy Research Repository to Characterize Post-stroke Epilepsy Population and Their Outcomes
- ClinicalTrials.gov ID
- NCT06108102
- Acronym / sponsor ID
- IPSERR / 2000032731
- Conditions
- Post Stroke Epilepsy, Post Stroke Seizure, Stroke, Epilepsy
- Keywords
- Post-stroke epilepsy, Clinical outcomes, Prognosis, Individual patient data
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Monash University
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 30 Oct 2023 (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.
The International Post-Stroke Epilepsy Research Repository (IPSERR): The study aims to collate and categorize data reported by post-stroke epilepsy (PSE) researchers and lodge it within the IPSERR. Using the IPSERR database, we will conduct two individual patient data (IPD) analyses: (1) determine epilepsy, functional, and cognitive outcomes in stroke patients who develop post-stroke seizure and (2) build and validate post-stroke epilepsy prediction model and compare performance against existing models.
Detailed description
The cerebrovascular disease is the most common cause of late-onset epilepsy. PSE is associated with increased morbidity, including cognitive decline, dependence, and poor quality of life, and is a critical determinant factor of stroke prognosis. We recently reported a systematic review and meta-analysis of 71 papers that suggested that post-stroke seizures are associated with more significant mortality and poor functional and cognitive outcomes (PMID:37721736). In this study, we observed disparate methods used by the individual investigators. We also noted variations in study reporting. PI aims to analyze existing individual patient data, including those analyzed in the systematic review, by collaborating with colleagues in the field and developing IPSERR into a resource for future collaborative studies that will tackle anti-epileptogenesis drug trial design.
Design and Rationale:
- International Post-Stroke Epilepsy Research Repository (IPSERR): The PI convened the International Post-Stroke Epilepsy Research Consortium (IPSERC) with co-convenor Dr. Patrick Kwan, Monash University, Australia. IPSERR was subsequently founded to collect retrospective and prospective PSE data to promote all aspects of PSE research. Participating centers will obtain legal approvals for human subject research as per the requirements of their jurisdiction. The PI (NKM) has IRB approval for IPSERR. A data use agreement (DUA) will be executed to receive data. The PI will invite the authors of all 71 papers in the systematic review to join IPSERC and request them to contribute data to IPSERR. A protocol (including the charter) for the proposed IPD analyses has been accepted for publication and will be available to the collaborators for review.
- The PI will use the Yale Center for Research Computing (YCRC) resources to manage IPSERR's clinical, radiological, and electrophysiological data.
- The PI will use Redcap for clinical data management. The Redcap server is housed within the Yale-New Haven Hospital secured data center behind their firewall. The databases are encrypted at rest for HIPAA compliance. Full database backups are made twice daily, seven days a week.
- Study duration: 2023-2029
- Rationale: Collaboration is vital for PSE research. This is because approximately 10% of stroke patients develop PSE. Together, investigators can collect a large sample of the PSE patient population and conduct robust analyses to draw meaningful conclusions. The collation of IPD from many different sources involving different interventions and stroke subpopulations will strengthen our ability to provide data for future research on many topics relating to PSE. The availability of high-speed internet has made it easier than ever to work closely with colleagues worldwide and share data. There are many examples of such successful efforts. For example, PI Dr. Mishra closely worked with the SITS-ISTR registry at Karolinska University, Stockholm, and the Virtual Stroke Trials Archive (VISTA) at the University of Glasgow, UK. These two international efforts recorded tPA and stroke trial data, respectively, and provided them for testing several hypotheses. Dr. Mishra subsequently worked at the US FDA, where he was exposed to other large collaborative scientific efforts like MDEpiNET. The PI seeks to capitalize on his experiences, network of colleagues worldwide, and recent technological advancement in data science to build the IPSERR. We anticipate that the IPSERR will bring together large datasets from previously conducted PSE research that would otherwise ordinarily remain dormant. The PI will request data from the authors of papers included in the systematic review (N=71 papers reporting approximately 20000 PSE patient data) and from the IPSERC members. The PI will report IPSERR in the first year and the results of the two research projects anchored on it in the second year. The PI will recognize that not all authors of the previously published literature in our systematic review will have data to share. However, even if 20% of the patient data is obtained from those studies, the PI expects an extensive database of approximately 8000 patients. With this success, the PI expects the IPSERR to continue growing. IPSERR will catalytically advance PSE research because it will provide the PSE research community with an extensive database for hypotheses testing and a framework to anchor future prospective studies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-stroke epilepsy | – | Other: Presence of stroke, either ischemic or hemorrhagic (intracerebral and subarachnoid)Stroke patients aged ≥18 years, with ischemic or hemorrhagic stroke, presenting with early or late onset post-stroke seizures. |
| No post-stroke epilepsy | – | Other: Presence of stroke, either ischemic or hemorrhagic (intracerebral and subarachnoid)Stroke patients aged ≥18 years, with ischemic or hemorrhagic stroke, presenting with no post-stroke seizures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stroke aged ≥18 years, with ischemic or hemorrhagic stroke, presenting with early or late post-stroke seizures. Patients presenting ≤1 week will be classified as early seizures and >1 week will be classified as late seizures.
Key inclusion criteria (5 listed)
- Studies with minimum dataset of 100 patients
- Studies comprising stroke patients aged ≥18 years, with ischemic or hemorrhagic stroke, presenting early or late PSS with data on patient outcome measures.
- Documented consent or waiver of consent following local Institutional Review Board-approved procedure.
- Studies published on human subjects.
- No restriction based on the date or language of publication, gender, or ethnicity.
Key exclusion criteria (2 listed)
- Studies of patients with a prior history of seizures before the index stroke,
- Studies that did not report outcome data, or are not able to share IPD.
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 |
|---|---|---|
| Presence of stroke, either ischemic or hemorrhagic (intracerebral and subarachnoid)Presence of ischemic or hemorrhagic stroke confirmed by neuroimaging and clinical diagnosis | Other | No post-stroke epilepsy, Post-stroke epilepsy |
Primary outcome
Mortality (modified Rankin Scale = 6)
Time frame: At 1 year, 2 year, and 5 year follow-up
The modified Rankin Scale (mRS) is a clinician-reported measure of global disability for evaluating recovery from stroke. It ranges from 0 (no symptoms) to 6 (death).
Poor functional outcome (modified Rankin Scale 3-6)
Time frame: At 1 year, 2 year, and 5 year follow-up
The modified Rankin Scale (mRS) is a clinician-reported measure of global disability for evaluating recovery from stroke. It ranges from 0 (no symptoms) to 6 (death), with 0-2 indicating a good functional outcome and 3-6 indicating a poor functional outcome.
Seizure frequency
Time frame: At 1 year, 2 year, and 5 year follow-up
Number of seizures post-stroke identified clinically or based on an electroencephalogram (EEG).
Seizure severity
Time frame: At 1 year, 2 year, and 5 year follow-up
Defined by impaired awareness and the presence of bilateral tonic or clonic seizures.
Occurrence or frequency of status epilepticus
Time frame: At 1 year, 2 year, and 5 year follow-up
Status epilepticus is defined as a seizure or series of seizures lasting more than 30 minutes without recovery of consciousness based on electroencephalogram (EEG) findings.
Length of hospital stay
Time frame: At 1 year, 2 year, and 5 year follow-up
The duration of hospital admission for a stroke is measured in days.
Cognitive decline assessed on an 11-question Mini-Mental State Examination (MMSE) tool or a 30-point Montreal Cognitive Assessment (MoCA) scale
Time frame: At 1 year, 2 year, and 5 year follow-up
MMSE is tests cognitive function. It is scored out of 30, with a score of ≤26 indicating cognitive impairment. MoCA assesses mild cognitive dysfunction. It is scored out of 30, with a score of ≤24 indicating cognitive impairment.
5 secondary outcomes
Recurrent stroke
Time frame: At 1 year, 2 year, and 5 year follow-up
Antiseizure medication discontinuation
Time frame: At 1 year, 2 year, and 5 year follow-up
Treatment adverse events
Time frame: At 1 year, 2 year, and 5 year follow-up
Depression assessed on 21-item Hamilton Depression Rating Scale (HAM-D)
Time frame: At 1 year, 2 year, and 5 year follow-up
Anxiety assessed on 14-item Hamilton Anxiety Rating Scale (HAM-A)
Time frame: At 1 year, 2 year, and 5 year follow-up
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 29 Oct 2025.
- Background: PubMed 37968000Mishra NK, Kwan P, Tanaka T, Sunnerhagen KS, Dawson J, Zhao Y, Misra S, Wang S, Sharma VK, Mazumder R, Funaro MC, Ihara M, Nicolo JP, Liebeskind DS, Yasuda CL, Cendes F, Quinn TJ, Ge Z, Scalzo F, Zelano J, Kasner SE; International Post-Stroke Epilepsy Research Consortium (IPSERC); International Post Stroke Epilepsy Research Consortium (IPSERC). Clinical characteristics and outcomes of patients with post-stroke epilepsy: protocol for an individual patient data meta-analysis from the International Post-stroke Epilepsy Research Repository (IPSERR). BMJ Open. 2023 Nov 15;13(11):e078684. doi: 10.1136/bmjopen-2023-078684.
- Individual participant dataSharing planned: Undecided. The PI (NKM) will create a centralized database, collect, and analyze PSE patient data, and establish common data protocols. IPSERR welcomes all PSE researchers as impartial members, granting membership to institutions. Each organization will have a role in the IPSERR steering committee. One named individual, usually the principal investigator of the contributing study, will represent the institution in the IPSERR. Steering committee members will review and approve research proposals. To address data concerns like confidentiality, reliability, and authorship, strict guidelines will be set for handling patient data, promoting ethical data sharing and collaborators' involvement in publications. Data will be securely stored, and access will be restricted to authorized individuals. The IPSERR constitution will define eligibility, data protection, storage, compatibility, and documentation.
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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.
Nishant K Mishra, MD PhD principal investigator
Yale University
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 Post Stroke Epilepsy and Post Stroke Seizure, run by Yale University at 1 site in United States.
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 2 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: enrolling by invitation, as of the sponsor's last update on 29 Oct 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 United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (modified Rankin Scale = 6) (time frame: At 1 year, 2 year, and 5 year follow-up). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06108102, which also lists 1 linked publication.
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 29 Oct 2025.