Handheld Point of Care Electro-Diagnostic Device

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Pregnant woman

PI unblinded by participant or LAR regarding indication or clinical data

Burns or extensive skin lesions

Implanted stimulation devices (any)

Trial design

Treatments tested in this trial

  • POC EEG

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators