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BSP

The Brain State Profile: a neuroimaging framework to elucidate the foundations of brain plasticity - BSP

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57977
Enrollment
24
Registered
2025-02-11
Start date
2025-10-10
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

brain plasticity functional magnetic resonance imaging cerebrovascular reactivity stroke recovery Stroke

Interventions

MRI scan en Respiract systeem (medical device used to precisely control and monitor the levels of carbon dioxide (CO2) and oxygen (O2) that a person inhales).

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Sufficient knowledge of the Dutch language to allow reliable use of standardized test  Age, 18 years or older First-ever unilateral stroke within the cerebrum or brainstem.Cognitive impairment based on assessment by the treating rehabilitation physician (at least <26 on the MoCA).Signed informed consent.

Exclusion criteria

Exclusion criteria: Unwilling or unable to cooperate with the breathing manoeuvres or keeping still Unable to provide consent by themselves due to severe cognitive impairment or (global/receptive) aphasiaStandard contraindications for 7T MRI scanning; Contraindications for using the RespirAct (see D2 IMDD 2.5 contraindications) including:Subjects refusing to undergo testingSubjects with obstructive or resistive lung disease whose PaCO2 at rest is greater than 50mmHg or whose venous serum bicarbonate is greater than 26 mEq/LSubjects with pre-existing respiratory acidosis. This will be determined during the test outside of the scanner. Respiratory acidosis will be inferred if they have a resting PaCO2 greater than 50 mmHg as measured by the RespirAct.Subjects who require portable oxygen at rest or with exerciseSubjects with chronic heart failure or severe pulmonary diseaseIncreased intracranial pressure or obstruction of outflow of CSFSymptoms of possible elevated intracranial pressure such as headache and nauseaFindings of significant edema (>10% brain volume, see section 11.4) or hydrocephalus in the last week.Metabolic acidosisPulmonary disease as diagnosed by a pulmonologist: oxygen dependency at rest or with exercise, restrictive lung disease with resting respiratory rate over 15 breaths/min; Concurrent severe or uncontrolled medical disease (e.g., active systemic infection); Body weight <30 kg, >120 kg; Pregnant during the studyUpper limb paresis prior to stroke onset Severe impairments that can impede study participation as determined by the treating rehabilitation physician (i.e. extreme fatigue, severe communication deficits). 

Design outcomes

Primary

MeasureTime frame
To identify what amount of changes in FC over time are explained by CVR. For this we use the marginal and partial R² from mixed-effects modelling.

Secondary

MeasureTime frame
A) To determine whether baseline CVR predict later FC normalization. For this we will compute changes to the laterality index (LI) for our parameters. B) To apply primary analysis methods to include possible changes in OEF.

Countries

Netherlands

Contacts

Public ContactA.A. Bhogal

Universitair Medisch Centrum Utrecht

a.bhogal@umcutrecht.nl0887551234

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)