Handheld Point Of Care Electro-Diagnostic Device
Study on a Handheld Device for Brain Health Check
Sergiu Abramovici
Primary Investigator
Brief description of study
We are developing a point of care, hand-held device, to be used by healthcare providers and assist them with clinical decision making and facilitate as well as expedite patient care, thus improving quality of care. The device we are studying is non-invasive, and we think it will improve quality of care, especially in areas with decreased access to resources.
Detailed description of study
The participants own clinical investigations (MRI, CT, EEG, etc.), as ordered by the treating team will serve as the SOC diagnostics and control, to which the POC investigational device performance will be compared. This trial will use documentation collected from the participant’s clinical medical record. The electrodiagnostic device will then be used at bedside on inpatient or outpatient Neurology and Neurosurgery patients, to determine lateralization, localization, and presumed etiology of their lesion. The POC investigational device will connect to a laptop via Bluetooth to review and analyze the data. The POC electrodiagnostic test data will lead to operator clinical insights (i.e. lateralization, localization and presumed nature of lesion), which will then be compared to the SOC data for validation.
The PI will apply the POC investigational device dry electrodes, as well as SOC SSEP stimulator to the participant and run a predetermined standardized diagnostic testing sequence, to cover all relevant locations (4 limbs, spine, head). The device connects to a laptop via a Bluetooth connection, and the acquired electrodiagnostic data is visualized on the screen.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: neurological condition
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Age: 18 years - 100 years
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Gender: All
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.
This study investigates a handheld, non-invasive electro-diagnostic device for use by healthcare providers. The purpose of this study is to assist in clinical decision-making and expedite patient care, particularly in areas with limited resources. The device is designed to help identify the location and nature of neurological lesions by analyzing data collected during standard medical procedures.
Participants will undergo electrodiagnostic testing using the device, which connects to a laptop via Bluetooth. The device's dry electrodes are applied to specific body locations such as the limbs, spine, and head. The data collected is then compared to standard diagnostic tests like MRI or CT scans to validate its accuracy. This process involves visualizing the electrodiagnostic data on a laptop screen to gain insights into the patient's condition.
- Who can participate: Adults aged 18 and over receiving inpatient or outpatient care at IU Health facilities, specifically at Methodist Hospital or the Neuroscience Center, are eligible. Participants must be under the care of a Neurology or Neurosurgery consultant and able to consent, or have a legally authorized representative to consent on their behalf.
- Study details: Participants will have the investigational device's electrodes applied to various body parts for testing. The device, which connects to a laptop, collects and displays data to help determine the nature of neurological lesions. The device's results are compared with standard care diagnostics to ensure accuracy.
