NCT06368024

Establishment of Delphi-MD Safety Performance and Reliability

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 263 (actual)
• Sponsor: QuantalX Neuroscience · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

Summary

A retrospective analysis of collected datasets. In this study we aim to establish Delphi-MD's safety and performance reliability for assessment and monitoring of Transcranial Magnetic Stimulation (TMS) Evoked Potentials (TEPs) as neurophysiological measurements.

Detailed description

A retrospective analysis of collected datasets. In this study we aim to establish Delphi-MD's safety and reliability for assessment and monitoring of TEP's as neurophysiological measurements. Safety: Upper limit of the 95% CI of the device related serious adverse event (SAE) rate is less than or equal to 3.6% Performance: Demonstrate differentiation of relevant clinical groups Reliability: An acceptable mean Interclass correlation (ICC) statistic (six stimulation) is at least 0.6 Additionally, the within subject variability should be lower than the between subject variability.

Conditions

• Neurologic Disorder
• Healthy

Interventions

Type	Name	Description
OTHER	This is a retrospective analysis study of data collected with a diagnostic medical device	Transcranial Magnetic stimulation and Electroencephalogram

Timeline

• Start date: 2023-11-28
• Primary completion: 2023-11-28
• Completion: 2023-11-28
• First posted: 2024-04-16
• Last updated: 2024-04-26

Locations

1 site across 1 country: Israel