Handheld device for quick bedside electrodiagnostic testing
Official title: Handheld Point of Care Electro-Diagnostic Device
Run by Indiana University · NCT07223827 · Data updated 2026-11-12
A handheld device that performs bedside EEG and stimulation tests to help neurologists quickly diagnose and treat adult patients seen at Indiana University Health.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Status | Recruiting |
| Started | January 10, 2026 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | February 9, 2026 |
| Trial ID | NCT07223827 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) seen as inpatients or outpatients at IU Health who are evaluated by neurology or neurosurgery and who can consent or have a legally authorized representative.
✕Probably not a fit
Patients who are pregnant, have extensive skin lesions or implanted stimulation devices, lack comparable standard imaging or paraclinical data, or have medical conditions that the PI judges would compromise safety or the study objectives may not receive benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study uses a handheld limited-electrode point-of-care electrodiagnostic device that is deployed and operated by the bedside provider to acquire real-time electrophysiologic data. The device records EEG signals and is used with standard stimulators to capture somatosensory (SSEP), visual (VEP) and brainstem auditory (BAEP) evoked potentials, with onboard analysis to inform immediate clinical decisions. Investigators plan to move the device between consenting adult inpatients and outpatients seen by neurology or neurosurgery at Indiana University Health and compare device-acquired data to standard-of-care imaging and paraclinical tests. The goal is to shorten time to diagnosis and treatment for acute neurologic and neurosurgical conditions while ensuring safety by excluding patients with implanted stimulators, extensive skin lesions, pregnancy, or other conditions judged by the PI to increase risk.
Why it matters
Potential benefit: If successful, the device could shorten time to diagnosis and treatment and improve outcomes by providing rapid bedside electrodiagnostic information.
How similar studies have gone: Several point-of-care EEG products exist and have shown promise for bedside monitoring, but the migrating handheld approach combining EEG with routine SSEP/VEP/BAEP acquisition is relatively novel and less tested.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Indiana University Health
Indianapolis, Indiana, United States Recruiting
Study contacts
- Principal investigator: Sergiu Abramovici, MD — Indiana University
- Study coordinator: Sergiu Abramovici, MD
- Email: sabramov@iu.edu
- Phone: 3172788090
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.