Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT05669456
Brief Summary:
This is a single-arm, observational, feasibility study to evaluate if the Halo Alert System can be used in the future to detect stroke events in individuals at risk for stroke wearing the Halo Alert System overnight.
Detailed Description:
This is a single-arm, observational, feasibility study to evaluate if the Halo Alert System can be used in the future to detect stroke events in individuals at risk for stroke wearing the Halo Alert System overnight. The Halo Alert System consists of an EEG sensor headband and is paired with a data transfer device. Approximately 300 subjects with elevated stroke risk will be enrolled and followed for a duration of 90 days. The EEG tracing for each study subject will be labeled after study conclusion with the help of clinically available information on the occurrence of a recurrent stroke. The labeled data will then be used to further develop the existing (operating room based) stroke detection algorithm and adjust the algorithm for outpatient use.
Study:
NCT05669456
Study Brief:
Protocol Section:
NCT05669456