Recruiting

POC Electrodiagnostic Device

Sponsor:

Indiana University

Code:

NCT07223827

Conditions

Neurologic Findings

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

POC EEG

Study Details

Brief 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

Study ID

NCT07223827

Start date

Jan 10, 2026

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Treatment Arm

Participants will be evaluated using the handheld POC device to compare diagnostic data collected vs. clinical diagnostic data

Interventions

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.

Primary outcome measure

  • Outcome 1 [ Time Frame: Day 0 ]
  • Outcome 2 [ Time Frame: Day 0 ]
  • Outcome 3 [ Time Frame: Day 0 ]

Central Contacts and Locations

Central contacts

Sergiu Abramovici, MD

3172788090sabramov@iu.edu

Lauren Perrey-Moore, BSN

3172788090lperrey@iu.edu

Locations

Indiana University Health

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Sergiu Abramovici, MD

3172788090sabramov@iu.edu

More Information

Sponsor

Indiana University

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-02-09.