NCT07223827 Handheld Point of Care Electro-Diagnostic Device
| NCT ID | NCT07223827 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | Neurologic Findings |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-01-10 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2026-01-10 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Sergiu Abramovici, MD
PRINCIPAL INVESTIGATOR
Indiana University
Frequently Asked Questions
Who can join the NCT07223827 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neurologic Findings. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07223827 currently recruiting?
Yes, NCT07223827 is actively recruiting participants. Contact the research team at sabramov@iu.edu for enrollment information.
Where is the NCT07223827 trial being conducted?
This trial is being conducted at Indianapolis, United States.
Who is sponsoring the NCT07223827 clinical trial?
NCT07223827 is sponsored by Indiana University. The principal investigator is Sergiu Abramovici, MD at Indiana University. The trial plans to enroll 30 participants.