Pediatric StrokePhase 4FOCASNCT06040255

Focal Cerebral Arteriopathy Steroid Trial

A Phase 4 study testing methylprednisolone, prednisolone, prednisone in people with Pediatric Stroke and Arteriopathy, run by University of California, San Francisco at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 1 year to 18 years
Conditions the study is for: Pediatric Stroke, Arteriopathy, Arterial Ischemic Stroke
What is being tested?: methylprednisolone, prednisolone, prednisone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2023to 31 Jan 2030
Phase: Phase 4
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 1 year to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Age 1 year through 18 years at stroke/TIA ictus (ineligible as of 19th birthday).
Acute arterial ischemic stroke (AIS) or transient ischemic attack (TIA) in prior 4 days (96 hours).
AIS definition: neurological deficit with acute onset (including seizures) and acute infarct(s) corresponding to arterial territory(ies) on brain imaging.
TIA definition: neurological deficit with acute onset (not including seizures) consistent with ischemia of an arterial territory(ies) but without acute infarction on brain imaging.
Imaging inclusion criteria:
Baseline imaging findings consistent with FCA: i. unilateral focal irregularity, banding, stenosis, wall thickening/enhancement, or occlusion of the distal internal carotid artery (ICA) and/or its proximal branches (A1, M1, posterior communicating artery, proximal PCA), OR ii. unilateral infarction in the territory of the lenticulostriate arteries with normal MRA.

Show all 9Show fewer

Ability to return at 1-month (±7 days) post-stroke for an MRI/MRA (non-contrast) on a scanner of the same magnet strength as baseline MRI/MRA.*
Consent to study procedures.
A repeat baseline MRI/MRA can be performed as a research scan within 24 hours of enrollment if needed to meet this requirement.

Who cannot join

Prior stroke.
Another identified cause of stroke/TIA, other than FCA. (Intracranial dissection is considered a subtype of FCA and will be included if the patient is not predisposed to dissection for the reasons listed below.)
Presence of childhood stroke risk factors (known to be present at the time of enrollment):
Risk factors for arterial dissection: connective tissue disorder (e.g., Ehlers-Danlos type IV, Marfan syndrome, osteogenesis imperfect); severe head or neck trauma in the two weeks preceding AIS/TIA (defined as skull or cervical fracture, or an ICU admission for trauma).
Risk factors for moyamoya: genetic disorder or syndrome that predisposes to moyamoya (e.g., trisomy 21, neurofibromatosis type 1, tuberous sclerosis, sickle cell anemia, MOPD type II, PHACE syndrome); prior cranial radiation therapy.
Risk factors for secondary vasculitis or vasospasm: acute meningitis, systemic lupus erythematosus or other autoimmune disorder that can cause vasculitis, recent cocaine/amphetamine use (prior 7 days), recent subarachnoid hemorrhage (prior 14 days).

Show all 13Show fewer

Risk factors for cardioembolism: complex congenital heart disease; recent cardiac surgery or catheterization (prior week); endocarditis or other cardiac valve disease with vegetations; right-to-left cardiac shunting lesion with deep vein thrombosis (DVT) or a known thrombophilia.
Imaging exclusion criteria:
Baseline parenchymal imaging demonstrating remote or bilateral infarcts
Vascular imaging demonstrating bilateral arteriopathy or moyamoya collaterals
Contraindication to corticosteroid therapy (e.g., baseline immunosuppression, significant infection, etc.) as determined by the treating physicians.
Current or recent (within prior week) treatment with corticosteroids.
Pregnant, post-partum (within 6 months of childbirth), or nursing.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

University of California San Francisco
San Francisco, California, 94158

Other trials in United States

About this study

This comparative effectiveness trial (CET) in children with suspected focal cerebral arteriopathy (FCA) presenting with arterial ischemic stroke (AIS) or transient ischemic attack (TIA) will compare the use of early corticosteroid treatment (Arm A) versus delayed/no corticosteroid treatment (Arm B). Delayed corticosteroid treatment is given only for those demonstrating disease progression and is initiated as soon as the progression is detected (at any time after randomization). All participants will also receive standard of care therapy (aspirin and supportive care). Sites will randomize participants 1:1 to Arm A or B. Participants will be enrolled and randomized as soon as possible after their stroke/TIA up until 96 hours following the initial stroke/TIA event.

Read the detailed description

FCA is an acute, monophasic, presumed inflammatory disease that causes unilateral stenosis of the intracranial anterior circulation. In the medical literature, it has also been called transient cerebral arteriopathy (TCA) and post-varicella arteriopathy when it occurs after chicken pox. Although rare (1 to 3 cases seen per year at a typical academic children's hospital in the US), it is one of the most common causes of arterial ischemic stroke in a previously healthy child. Pediatric stroke investigators identified an FCA treatment trial as the #1 priority of the field (Steinlin M, Dev Med Child Neurol 2017) because of its aggressive natural history: it often progresses dramatically over days to weeks with recurrent or expanding infarcts. A 2017 European retrospective cohort study suggested that corticosteroid treatment may improve outcomes for FCA (Steinlin M, Stroke 2017).

Europeans have begun the PASTA (Paediatric Arteriopathy STeroid Aspirin) trial (PI Steinlin): a "gold-standard" RCT to test the efficacy of corticosteroids for FCA. A 2018 survey of pediatric stroke investigators (participating in the NIH-funded Vascular effects of Infection in Pediatric Stroke, VIPS II, cohort study) revealed discomfort with randomization to "no steroids" as the majority now treat FCA with corticosteroids. However, despite attitudes favoring their use, corticosteroids were given to only 36% of 55 children with suspected FCA in the VIPS II cohort and (when given) were started a median of 3 days post-stroke (IQR 1.5, 6) (unpublished preliminary data). This incongruity reflects diagnostic uncertainty at stroke baseline: the characteristic arteriopathy evolution is needed for definitive diagnosis of FCA, and ≈1 in 5 children with suspected FCA at baseline have an alternate diagnosis. Hence, the pressing clinical question is: Should we treat all children with suspected FCA immediately or wait and treat only the subset that demonstrate disease progression?

Early treatment has the potential advantage of preventing FCA progression, but the disadvantage of over treatment of those with alternate diagnoses. With a comparative effectiveness approach, the FOCAS trial will compare these two treatment approaches. FOCAS will also collect the steroid treatment safety data needed to guide clinical decisions.

Conditions: Pediatric Stroke, Arteriopathy, Arterial Ischemic Stroke
Being tested: methylprednisolone, prednisolone, prednisone
Keywords: FCA, Focal cerebral arteriopathy, Pediatric stroke, Arterial ischemic stroke
Medical subject headings: Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

methylprednisolone, prednisolone, prednisoneDrug
Any generic or brand-name methylprednisolone at the appropriate dose may be used. Likewise, any generic or brand-name prednisolone, or prednisone, at the appropriate dose may be used.

Study groups in NCT06040255
Study group	Role	What they receive
Arm A	Active comparator	Treat all children with suspected FCA with corticosteroids as soon as the diagnosis is made. Receives: Drug: methylprednisolone, prednisolone, prednisone
Arm B	Active comparator	Treat only the subset of children that develop evidence of FCA disease progression. Receives: Drug: methylprednisolone, prednisolone, prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Focal Cerebral Arteriopathy Severity Score (FCASS)
Change in FCASS from baseline to 1 month (1-month delta FCASS) measured centrally on MRA studies (performed on scanners with the same magnet strength).
The FCASS is a novel ordinal scale designed and validated for the FOCAS and PASTA trials (Fullerton HJ, Stroke, 2018; Slalova, Eur J Paediatr Neurol, 2020) . The FCASS sums the severity of involvement of each of 5 different arterial segments that can be involved in FCA: (1) supraclinoid ICA (very common), (2) M1 segment of the MCA (very common), (3) M2 branches, (4) A1 segment of the ACA, (5) A2 branches of the ACA. The involvement of the ICA, M1, and A1 are scored on a scale of 0 to 4: 0=no involvement, 1=irregularity or banding without stenosis, 2=less than 50% stenosis, 3= 50% stenosis or greater), 4=complete occlusion. The M2 and A2 are scored: 0=no involvement, 1=irregularity, 3=stenosis, 4=complete occlusion (no option for 2).
Measured: Baseline to one month

Secondary outcomes (6)

Focal Cerebral Arteriopathy Severity Score (FCASS) at 1 month (required)
In addition to analyzing the change in FCASS from baseline to 1 month, we will analyze the absolute FCASS at 1 month. VIPS data suggest that the 1-month measurement should best approximate the maximum FCASS.
FCASS sums the severity of involvement of each of 5 different arterial segments that can be involved in Focal Cerebral Arteriopathy: (1) supraclinoid ICA, (2) M1 segment of the MCA, (3) M2 branches, (4) A1 segment of the ACA, (5) A2 branches. Each segment is scored: 0 (normal), 1 (irregularity without stenosis), 2 (<50% stenosis), 3 (>50% stenosis), or 4 (complete occlusion). The total score can range from 0 to 20. Arteriopathy progression has an increase in the FCASS, while arteriopathy improvement has a decrease in the FCASS.
Measured: Baseline to 1 month
Focal Cerebral Arteriopathy Severity Score (FCASS) at 1 month at 12 months (when imaging is available)
We will also analyze the FCASS at 12 months, which should approximate the final FCASS value (after recovery).
FCASS sums the severity of involvement of each of 5 different arterial segments that can be involved in Focal Cerebral Arteriopathy: (1) supraclinoid ICA, (2) M1 segment of the MCA, (3) M2 branches, (4) A1 segment of the ACA, (5) A2 branches. Each segment is scored: 0 (normal), 1 (irregularity without stenosis), 2 (<50% stenosis), 3 (>50% stenosis), or 4 (complete occlusion). The total score can range from 0 to 20. Arteriopathy progression has an increase in the FCASS, while arteriopathy improvement has a decrease in the FCASS.
Measured: Baseline to 12 months
Relative infarct volume at 1 month (required)
Study neuroradiologists, blinded to the treatment arm and imaging date, will estimate relative infarct volume at 1 month. They will first estimate the absolute infarct volume using ABC/2.39 They will delineate the infarct contour and the brain contour on FLAIR images and, taking into account FLAIR slice thickness, calculate the absolute infarct volume and total brain volume. To account for smaller head sizes in young children, they will then calculate the relative infarct volume as a percent of total brain volume.
Measured: 1 month after baseline
Relative infarct volume at 12 months (when imaging is available)
Study neuroradiologists, blinded to the treatment arm and imaging date, will estimate relative infarct volume at 1 month. They will first estimate the absolute infarct volume using ABC/2.39 They will delineate the infarct contour and the brain contour on FLAIR images and, taking into account FLAIR slice thickness, calculate the absolute infarct volume and total brain volume. To account for smaller head sizes in young children, they will then calculate the relative infarct volume as a percent of total brain volume. They will use similar methodology to also estimate the final infarct volume at 12 months.
Measured: 12 months after baseline
Pediatric Stroke Outcome Measure (PSOM) at 6 months
The PSOM can be measured via the Pediatric Stroke Recurrence and Recovery Questionnaire (RRQ) if only telephone follow-up is feasible. The PSOM scale ranges from 0 to 10, but 6- and 12-month measurements typically cluster between 0 and 3, with any value ≥1 considered a "poor outcome." The median 1-year PSOM in our FCA cohort (N=39 with 1-year outcomes) was 1 (IQR 0, 1.5; range 0, 4.5). 2 In VIPS, higher maximum FCASS correlated with higher PSOM scores, indicating poorer outcomes (p=0.037).
Measured: 6 months after baseline
Pediatric Stroke Outcome Measure (PSOM) at 12 months (when feasible)
The PSOM can be measured via the Pediatric Stroke Recurrence and Recovery Questionnaire (RRQ) if only telephone follow-up is feasible. The PSOM scale ranges from 0 to 10, but 6- and 12-month measurements typically cluster between 0 and 3, with any value ≥1 considered a "poor outcome." The median 1-year PSOM in our FCA cohort (N=39 with 1-year outcomes) was 1 (IQR 0, 1.5; range 0, 4.5). 2 In VIPS, higher maximum FCASS correlated with higher PSOM scores, indicating poorer outcomes (p=0.037).
Measured: 12 months after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 202331 Jan 2030

First posted15 Sep 2023
Study start1 Oct 2023
Primary completion31 Jul 2029 (estimated)
Study completion31 Jan 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Pediatric StrokeStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe 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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06040255
Sponsor's protocol ID: UH3NS119702
Other IDs: 4UH3NS119702-02
Acronym: FOCAS
Status last verified: Jan 2026
First submitted: 8 Sep 2023
Last updated: 26 Jan 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Wintermark M, Hills NK, DeVeber GA, Barkovich AJ, Bernard TJ, Friedman NR, Mackay MT, Kirton A, Zhu G, Leiva-Salinas C, Hou Q, Fullerton HJ; VIPS Investigators. Clinical and Imaging Characteristics of Arteriopathy Subtypes in Children with Arterial Ischemic Stroke: Results of the VIPS Study. AJNR Am J Neuroradiol. 2017 Nov;38(11):2172-2179. doi: 10.3174/ajnr.A5376. Epub 2017 Oct 5.
PubMed 28982784
Fullerton HJ, Stence N, Hills NK, Jiang B, Amlie-Lefond C, Bernard TJ, Friedman NR, Ichord R, Mackay MT, Rafay MF, Chabrier S, Steinlin M, Elkind MSV, deVeber GA, Wintermark M; VIPS Investigators. Focal Cerebral Arteriopathy of Childhood: Novel Severity Score and Natural History. Stroke. 2018 Nov;49(11):2590-2596. doi: 10.1161/STROKEAHA.118.021556.
PubMed 30355212
Elkind MS, Hills NK, Glaser CA, Lo WD, Amlie-Lefond C, Dlamini N, Kneen R, Hod EA, Wintermark M, deVeber GA, Fullerton HJ; VIPS Investigators*. Herpesvirus Infections and Childhood Arterial Ischemic Stroke: Results of the VIPS Study. Circulation. 2016 Feb 23;133(8):732-41. doi: 10.1161/CIRCULATIONAHA.115.018595. Epub 2016 Jan 26.
PubMed 26813104
Steinlin M, Bigi S, Stojanovski B, Gajera J, Regenyi M, El-Koussy M, Mackay MT; Swiss NeuroPediatric Stroke Registry. Focal Cerebral Arteriopathy: Do Steroids Improve Outcome? Stroke. 2017 Sep;48(9):2375-2382. doi: 10.1161/STROKEAHA.117.016818. Epub 2017 Jul 21.
PubMed 28733481
Steinlin M, O'callaghan F, Mackay MT. Planning interventional trials in childhood arterial ischaemic stroke using a Delphi consensus process. Dev Med Child Neurol. 2017 Jul;59(7):713-718. doi: 10.1111/dmcn.13393. Epub 2017 Jan 25.
PubMed 28121022
Fullerton HJ, Hills NK, Elkind MS, Dowling MM, Wintermark M, Glaser CA, Tan M, Rivkin MJ, Titomanlio L, Barkovich AJ, deVeber GA; VIPS Investigators. Infection, vaccination, and childhood arterial ischemic stroke: Results of the VIPS study. Neurology. 2015 Oct 27;85(17):1459-66. doi: 10.1212/WNL.0000000000002065. Epub 2015 Sep 30.
PubMed 26423434
Lanthier S, Armstrong D, Domi T, deVeber G. Post-varicella arteriopathy of childhood: natural history of vascular stenosis. Neurology. 2005 Feb 22;64(4):660-3. doi: 10.1212/01.WNL.0000151851.66154.27.
PubMed 15728288
Chabrier S, Rodesch G, Lasjaunias P, Tardieu M, Landrieu P, Sebire G. Transient cerebral arteriopathy: a disorder recognized by serial angiograms in children with stroke. J Child Neurol. 1998 Jan;13(1):27-32. doi: 10.1177/088307389801300105.
PubMed 9477245
Braun KP, Bulder MM, Chabrier S, Kirkham FJ, Uiterwaal CS, Tardieu M, Sebire G. The course and outcome of unilateral intracranial arteriopathy in 79 children with ischaemic stroke. Brain. 2009 Feb;132(Pt 2):544-57. doi: 10.1093/brain/awn313. Epub 2008 Nov 27.
PubMed 19039009
Slavova N, Fullerton HJ, Hills NK, Breiding PS, Mackay MT, Steinlin M. Validation of the focal cerebral arteriopathy severity score (FCASS) in a Swiss cohort: Correlation with infarct volume and outcome. Eur J Paediatr Neurol. 2020 Sep;28:58-63. doi: 10.1016/j.ejpn.2020.07.015. Epub 2020 Aug 4.
PubMed 32826156
Lo WD, Ichord RN, Dowling MM, Rafay M, Templeton J, Halperin A, Smith SE, Licht DJ, Moharir M, Askalan R, Deveber G; International Pediatric Stroke Study (IPSS) Investigators. The Pediatric Stroke Recurrence and Recovery Questionnaire: validation in a prospective cohort. Neurology. 2012 Aug 28;79(9):864-70. doi: 10.1212/WNL.0b013e318266fc9a. Epub 2012 Aug 15.
PubMed 22895580
Schechter T, Kirton A, Laughlin S, Pontigon AM, Finkelstein Y, MacGregor D, Chan A, deVeber G, Brandao LR. Safety of anticoagulants in children with arterial ischemic stroke. Blood. 2012 Jan 26;119(4):949-56. doi: 10.1182/blood-2011-06-361535. Epub 2011 Dec 7.
PubMed 22160380
Fullerton HJ, Hills NK, Chen H, Dlamini N, Stence NV, Wintermark M; VIPS II Investigators. Changing Management of Focal Cerebral Arteriopathy of Childhood From 2010 to 2022. Stroke. 2025 Jun;56(6):1460-1468. doi: 10.1161/STROKEAHA.124.050550. Epub 2025 May 12.
PubMed 40351190

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Pediatric Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Focal Cerebral Arteriopathy Steroid Trial
ClinicalTrials.gov ID: NCT06040255
Acronym / sponsor ID: FOCAS / UH3NS119702
Conditions: Pediatric Stroke, Arteriopathy, Arterial Ischemic Stroke
Keywords: FCA, Focal cerebral arteriopathy, Pediatric stroke, Arterial ischemic stroke
Phase: Phase 4
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 80 participants (estimated)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Collaborators: University of Cincinnati, Medical University of South Carolina, M.D. Anderson Cancer Center, University of Colorado, Denver, University of Iowa, National Institute of Neurological Disorders and Stroke (NINDS), American Heart Association
Study start: 1 Oct 2023 (actual)
Primary completion: 31 Jul 2029 (estimated)
Study completion: 31 Jan 2030 (estimated)
First posted: 15 Sep 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Arm A	Active comparator	Drug: methylprednisolone, prednisolone, prednisoneTreat all children with suspected FCA with corticosteroids as soon as the diagnosis is made.
Arm B	Active comparator	Drug: methylprednisolone, prednisolone, prednisoneTreat only the subset of children that develop evidence of FCA disease progression.

Who may qualify

Ages: 1 year to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (9 listed)

Age 1 year through 18 years at stroke/TIA ictus (ineligible as of 19th birthday).
Acute arterial ischemic stroke (AIS) or transient ischemic attack (TIA) in prior 4 days (96 hours).
Imaging inclusion criteria:
Consent to study procedures.

Key exclusion criteria (13 listed)

Prior stroke.
Another identified cause of stroke/TIA, other than FCA. (Intracranial dissection is considered a subtype of FCA and will be included if the patient is not predisposed to dissection for the reasons listed below.)
Presence of childhood stroke risk factors (known to be present at the time of enrollment):
Imaging exclusion criteria:
Contraindication to corticosteroid therapy (e.g., baseline immunosuppression, significant infection, etc.) as determined by the treating physicians.

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
methylprednisolone, prednisolone, prednisoneAny generic or brand-name methylprednisolone at the appropriate dose may be used. Likewise, any generic or brand-name prednisolone, or prednisone, at the appropriate dose may be used.	Drug	Arm A, Arm B

Primary outcome

Change in Focal Cerebral Arteriopathy Severity Score (FCASS)
Time frame: Baseline to one month
Change in FCASS from baseline to 1 month (1-month delta FCASS) measured centrally on MRA studies (performed on scanners with the same magnet strength). The FCASS is a novel ordinal scale designed and validated for the FOCAS and PASTA trials (Fullerton HJ, Stroke, 2018; Slalova, Eur J Paediatr Neurol, 2020) . The FCASS sums the severity of involvement of each of 5 different arterial segments that can be involved in FCA: (1) supraclinoid ICA (very common), (2) M1 segment of the MCA (very common), (3) M2 branches, (4) A1 segment of the ACA, (5) A2 branches of the ACA. The involvement of the ICA, M1, and A1 are scored on a scale of 0 to 4: 0=no involvement, 1=irregularity or banding without stenosis, 2=less than 50% stenosis, 3= 50% stenosis or greater), 4=complete occlusion. The M2 and A2 are scored: 0=no involvement, 1=irregularity, 3=stenosis, 4=complete occlusion (no option for 2).

6 secondary outcomes

Focal Cerebral Arteriopathy Severity Score (FCASS) at 1 month (required)
Time frame: Baseline to 1 month
Focal Cerebral Arteriopathy Severity Score (FCASS) at 1 month at 12 months (when imaging is available)
Time frame: Baseline to 12 months
Relative infarct volume at 1 month (required)
Time frame: 1 month after baseline
Relative infarct volume at 12 months (when imaging is available)
Time frame: 12 months after baseline
Pediatric Stroke Outcome Measure (PSOM) at 6 months
Time frame: 6 months after baseline
Pediatric Stroke Outcome Measure (PSOM) at 12 months (when feasible)
Time frame: 12 months after baseline

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 26 Jan 2026.
Background: PubMed 28982784Wintermark M, Hills NK, DeVeber GA, Barkovich AJ, Bernard TJ, Friedman NR, Mackay MT, Kirton A, Zhu G, Leiva-Salinas C, Hou Q, Fullerton HJ; VIPS Investigators. Clinical and Imaging Characteristics of Arteriopathy Subtypes in Children with Arterial Ischemic Stroke: Results of the VIPS Study. AJNR Am J Neuroradiol. 2017 Nov;38(11):2172-2179. doi: 10.3174/ajnr.A5376. Epub 2017 Oct 5.
Background: PubMed 30355212Fullerton HJ, Stence N, Hills NK, Jiang B, Amlie-Lefond C, Bernard TJ, Friedman NR, Ichord R, Mackay MT, Rafay MF, Chabrier S, Steinlin M, Elkind MSV, deVeber GA, Wintermark M; VIPS Investigators. Focal Cerebral Arteriopathy of Childhood: Novel Severity Score and Natural History. Stroke. 2018 Nov;49(11):2590-2596. doi: 10.1161/STROKEAHA.118.021556.
Background: PubMed 26813104Elkind MS, Hills NK, Glaser CA, Lo WD, Amlie-Lefond C, Dlamini N, Kneen R, Hod EA, Wintermark M, deVeber GA, Fullerton HJ; VIPS Investigators*. Herpesvirus Infections and Childhood Arterial Ischemic Stroke: Results of the VIPS Study. Circulation. 2016 Feb 23;133(8):732-41. doi: 10.1161/CIRCULATIONAHA.115.018595. Epub 2016 Jan 26.
Background: PubMed 28733481Steinlin M, Bigi S, Stojanovski B, Gajera J, Regenyi M, El-Koussy M, Mackay MT; Swiss NeuroPediatric Stroke Registry. Focal Cerebral Arteriopathy: Do Steroids Improve Outcome? Stroke. 2017 Sep;48(9):2375-2382. doi: 10.1161/STROKEAHA.117.016818. Epub 2017 Jul 21.
Background: PubMed 28121022Steinlin M, O'callaghan F, Mackay MT. Planning interventional trials in childhood arterial ischaemic stroke using a Delphi consensus process. Dev Med Child Neurol. 2017 Jul;59(7):713-718. doi: 10.1111/dmcn.13393. Epub 2017 Jan 25.
Background: PubMed 26423434Fullerton HJ, Hills NK, Elkind MS, Dowling MM, Wintermark M, Glaser CA, Tan M, Rivkin MJ, Titomanlio L, Barkovich AJ, deVeber GA; VIPS Investigators. Infection, vaccination, and childhood arterial ischemic stroke: Results of the VIPS study. Neurology. 2015 Oct 27;85(17):1459-66. doi: 10.1212/WNL.0000000000002065. Epub 2015 Sep 30.
Background: PubMed 15728288Lanthier S, Armstrong D, Domi T, deVeber G. Post-varicella arteriopathy of childhood: natural history of vascular stenosis. Neurology. 2005 Feb 22;64(4):660-3. doi: 10.1212/01.WNL.0000151851.66154.27.
Background: PubMed 9477245Chabrier S, Rodesch G, Lasjaunias P, Tardieu M, Landrieu P, Sebire G. Transient cerebral arteriopathy: a disorder recognized by serial angiograms in children with stroke. J Child Neurol. 1998 Jan;13(1):27-32. doi: 10.1177/088307389801300105.
Background: PubMed 19039009Braun KP, Bulder MM, Chabrier S, Kirkham FJ, Uiterwaal CS, Tardieu M, Sebire G. The course and outcome of unilateral intracranial arteriopathy in 79 children with ischaemic stroke. Brain. 2009 Feb;132(Pt 2):544-57. doi: 10.1093/brain/awn313. Epub 2008 Nov 27.
Background: PubMed 32826156Slavova N, Fullerton HJ, Hills NK, Breiding PS, Mackay MT, Steinlin M. Validation of the focal cerebral arteriopathy severity score (FCASS) in a Swiss cohort: Correlation with infarct volume and outcome. Eur J Paediatr Neurol. 2020 Sep;28:58-63. doi: 10.1016/j.ejpn.2020.07.015. Epub 2020 Aug 4.
Background: PubMed 22895580Lo WD, Ichord RN, Dowling MM, Rafay M, Templeton J, Halperin A, Smith SE, Licht DJ, Moharir M, Askalan R, Deveber G; International Pediatric Stroke Study (IPSS) Investigators. The Pediatric Stroke Recurrence and Recovery Questionnaire: validation in a prospective cohort. Neurology. 2012 Aug 28;79(9):864-70. doi: 10.1212/WNL.0b013e318266fc9a. Epub 2012 Aug 15.
Background: PubMed 22160380Schechter T, Kirton A, Laughlin S, Pontigon AM, Finkelstein Y, MacGregor D, Chan A, deVeber G, Brandao LR. Safety of anticoagulants in children with arterial ischemic stroke. Blood. 2012 Jan 26;119(4):949-56. doi: 10.1182/blood-2011-06-361535. Epub 2011 Dec 7.
Individual participant dataSharing planned: No

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Acute Ischemic Stroke (AIS), Pediatric Stroke
RecruitingObservational study
The FBRI VTC Neuromotor Research Clinic
Neuromotor Impairments, Cerebral Palsy
Recruiting
Effects of Modified CIMT With and Without PNF
Pediatric Stroke

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.

Heather J Fullerton, MD, MAS principal investigator

University of California, San Francisco

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing methylprednisolone, prednisolone, prednisone in people with Pediatric Stroke and Arteriopathy, run by University of California, San Francisco 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 9 inclusion and 13 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 26 Jan 2026. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Change in Focal Cerebral Arteriopathy Severity Score (FCASS) (time frame: Baseline to one month). 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 NCT06040255, which also lists 13 linked publications.

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 26 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.