Overview
Tab Title Description
Tipo de estudio
ObservationalDescribe la naturaleza de un estudio clínico. Los tipos incluyen los siguientes:
- Estudio observacional, en el que se observan personas y se miden los resultados sin afectarlos.
- Estudio intervencionista (ensayo clínico), en el que se estudian nuevos exámenes, tratamientos, medicamentos, procedimientos quirúrgicos o dispositivos.
- Las investigaciones basadas en expedientes médicos utilizan la información histórica recopilada a partir de los registros médicos de grandes grupos de personas para estudiar cómo evolucionan las enfermedades y qué tratamientos y cirugías son más eficaces.
Identificaciones del estudio
Comité de revisión institucional de la sede
- Jacksonville, Florida: 21-007299
Información sobre este estudio
The purpose of this study is to prove that virtual reality technology can be utilized to improve the reliabilty and accuracy of components of the neurologic examination compared to remote telemedicine encounter.
We plan to build a prototype device using existing virtual reality (VR) headset, the Pico Neo 3 Pro Eye. This system incorporates eye and limb tracking technology that will enable us to develop software programs/modules that allow physicians to assess components of the neurologic examination including level of consciousness, extraocular movements, gaze preference, visual fields, visual neglect, visual acuity, pupillary response, arm drift, ataxia, language (aphasia), and speech (dysarthria). We plan to test the performance of the VR headset examination against both the in-person bedside National Institutes of Health Stroke Scale (NIHSS) and the telemedicine NIHSS examination.
Research subjects will include prospectively identified patients admitted to the hospital in the setting of acute stroke with last known well time within 7 days. We plan to test the performance of the VR headset examination against both the in-person bedside neurologic examination and audio-visual telemedicine examination. Research subjects will be tested in series using all three testing platforms and then interrater reliability of the VR headset will be evaluated by comparing to the other two validated testing modalities.
As part of the study, data collection from medical record will include age, gender, ethnicity, preferred language, handedness (left or right), baseline admission NIHSS, stroke subtype (ischemic or hemorrhagic), stroke location (dominant or nondominant hemisphere), and if ischemic—stroke mechanism (lacunar vs nonlacunar), anterior or posterior circulation, and (if applicable) arterial territory. Additionally, participants will be asked to fill out a questionnaire following completion of the VR assessment to assess subjective measures including device comfort, quality of testing, and user friendliness.
Following validation of the VR testing modules, we plan to use the anonymized data from the VR headsets to develop supervised machine learning models that can automatically score components of the neurologic assessment.
Elegibilidad para la participación
Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
Inclusion Criteria:
- Adult patients, ≥ 18 years.
- Patients admitted to the hospital with diagnosis of acute stroke within 7 days of last known well.
Exclusion Criteria:
- Patients with pre-existing functionally limiting visual impairment (e.g., macular degeneration).
- Physical barriers to headset placement (e.g., prolonged EEG monitoring, recent craniectomy).
- Pre-existing neurological condition (such as advanced dementia) expected to confound the assessment as determined by the treating neurologist.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 10/25/23. Questions regarding updates should be directed to the study team contact.