Handheld device for quick bedside electrodiagnostic testing
Handheld Point of Care Electro-Diagnostic Device
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT07223827 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Indianapolis, Indiana
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.