Handheld Point of Care Electro-Diagnostic Device

Indiana University30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Neurologic Findings

Interventions

POC EEGDIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Outcome 1

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. The investigator then plans to compare the clinical insight obtained by using the POC investigational device, to SOC.

Time frame: Day 0

Outcome 2

The diagnostic insights acquired using the POC investigation device regarding localization (cerebral - frontal, temporal, parieto-occipital; spinal - cervical, thoracal, lumbosacral; or radicular),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.

Time frame: Day 0

Outcome 3

The diagnostic insights acquired using the POC investigation device regarding the 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.

Time frame: Day 0

Handheld Point of Care Electro-Diagnostic Device

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts