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Study of a non-invasive brain health assessment device

Validation study of the version 2.0 of a non-invasive device for assessing Intracranial Pressure and Compliance

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-4srptw4
Enrollment
Unknown
Registered
2023-03-10
Start date
2023-06-20
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Intracranial pressure

Interventions

Will be recruited for the study, 67 people of both sexes, over 18 years and all participants must meet the eligibility criteria. Participants will be recruited from community, such as universities, gy

Sponsors

Braincare Desenvolvimento e Inovação Tecnologia SA
Lead Sponsor
Braincare Desenvolvimento e Inovação Tecnologia SA
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: People aged 18 years and older will be admitted to participate in the study; who read the consent form and agree to participate in the study

Exclusion criteria

Exclusion criteria: Volunteers who at some point wish to withdraw from the study; who experience discomfort or excessive movement during the evaluations

Design outcomes

Primary

MeasureTime frame
To characterize and validate the quality of the intracranial pressure curve and its associated parameters of a miniaturized device for non-invasive monitoring of intracranial compliance developed by the company Braincare Desenvolvimento e Inovação Tecnológica S.A.

Secondary

MeasureTime frame
Identify the ideal positioning(s) and adjustment(s) of the miniaturized device in humans, related to the quality and stability of the intracranial pressure curve and its associated parameters. Identify the repeatability and reproducibility of the intracranial pressure curve and associated parameters of the miniaturized device when compared to the same information on the BWS device. Understand the variability and stability of the intracranial pressure curve and its associated parameters, in different volunteers, related to the laterality of the hemisphere to be monitored and the position of the volunteer.

Countries

Brazil

Contacts

Public ContactGabriela Ocamoto

Braincare Desenvolvimento e Inovação Tecnologia SA

gabriela.ocamoto@brain4.care+55 16 99260-5725

Outcome results

None listed

Source: REBEC (via WHO ICTRP)