Handheld Point of Care Electro-Diagnostic Device

Not Applicable

Not yet recruiting

• Conditions: Neurologic Findings

• Registration Number: NCT07223827
• Lead Sponsor: Indiana University

Brief Summary

There are currently several products offering POC EEG, intended to be deployed on each patient individually and continuously. We 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, we 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-30
• Study First Submitted QC: 2025-10-30
• Last Update Submitted: 2025-10-30
• Study First Posted: 2025-11-03
• Last Update Posted: 2025-11-03
• Study Start: 2025-12-01
• Primary Completion: 2026-12
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients 18 years old or above
• Seen inpatient or in outpatient service at IU Health facilities - Methodist Hospital, and the Neuroscience Center, by a Neurology and/or Neurosurgery consultant as part of their SOC.
• The participant has capacity to sign consent or has an assigned LAR (Legally Authorized Representative - Spouse, parent, sibling, etc.) able to consent on their behalf.

Exclusion Criteria

• Pregnant woman
• PI unblinded by participant or LAR regarding indication or clinical data
• Burns or extensive skin lesions
• Implanted stimulation devices (any)
• Participant without standard imaging and, or other paraclinical SOC investigations to be comparable to the POC investigational device acquired data.
• Significant acute or chronic medical, neurologic, or other illness in the patient that, in the judgment of the PI, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Able to determine diagnostic insights regarding lateralization, localization, and presumed nature of lesion	2 years	The diagnostic insights acquired using the POC investigation device regarding lateralization (left/right), localization (cerebral - frontal, temporal, parieto-occipital; spinal - cervical, thoracal, lumbosacral; or radicular), and presumed nature of lesion (i.e. ischemia, hemorrhage, space-occupying lesion), are significantly comparable to, and congruent with, the SOC diagnostic insight regarding same parameters (lateralization, localization and presumed etiology) acquired using SOC techniques such as MRI, 10-20 (standard ubiquity used electrode montage) EEG systems, SSEP, etc. The PI will be the only POC investigational device operator, and will be blinded to patient examination, symptoms and SOC investigation results. The PI will be blinded to all EMR data. We then plan to compare the clinical insight obtained by using the POC investigational device, to SOC.

Trial Locations

Locations (1)

Indiana University Health; 🇺🇸 Indianapolis, Indiana, United States