NCT07223827

Handheld Point of Care Electro-Diagnostic Device

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

There are currently several products offering POC EEG, intended to be deployed on each patient individually and continuously. The investigators propose studying a different approach by using a migrating POC electrodiagnostic device that is deployed directly by the onsite provider and is actively used, like other POC devices, to acquire real-time diagnostic insight and facilitate immediate medical decision making. This can significantly shorten time to treatment which in several neurological and neurosurgical conditions, and thus, can significantly improve patient outcome. The investigational POC investigational device is based on a handheld limited electrode array, complemented by various stimulation modalities such as SSEP, VEP and BAEP, and potentially other sensors. For this study, the investigators intend to use readily available industry standard stimulators and only use the proposed POC investigational device to acquire and analyze the data. The POC investigational electrodiagnostic prototype was assembled using OpenBCI8 electronic board and electrodes, based on ADS 129X chip by Texas Instruments, that was shown to provide an adequate low-cost solution for electrodiagnostic data acquisition.

Conditions

• Neurologic Findings

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	POC EEG	The PI will apply the POC investigational device dry electrodes, as well as SOC SSEP stimulator to the participant and run a standardized diagnostic testing sequence, to cover all 4 limbs, spine, and head. The device connects to a laptop via Bluetooth, and the acquired electrodiagnostic data is visualized on the screen. The PI will analyze the acquired data and determine lateralization, localization, and presumed nature of the lesion or pathology causing the patient's symptoms. The direct contact with the participant should take10-20 minutes. The inferred lateralization, localization, and nature of the presumed lesion, will be then documented, to be compared to the diagnostic insight of using SOC diagnostic methods such as CT, MRI, EEG, SSEP, etc. The participant will receive their regular SOC management and a single, brief evaluation using the POC investigational device.

Timeline

• Start date: 2026-01-10
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-11-03
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study