Handheld Diagnostic Device for Neurological Disorders
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new handheld device designed to help doctors quickly diagnose neurological disorders. The goal is to determine if this point-of-care electro-diagnostic device can provide real-time information to improve patient care and expedite treatment. Patients 18 and older receiving care at IU Health facilities, who can give consent or have a representative do so, are eligible to participate. The device will assess participants, and its data will be compared with standard clinical diagnostics. As an unphased trial, this study allows patients to contribute to innovative diagnostic advancements that could enhance future neurological care.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this handheld diagnostic device is safe for neurological disorders?
Research has shown that the handheld point-of-care (POC) electro-diagnostic device is generally considered safe. It uses technology from Texas Instruments and relies on a reliable electronic board. This setup offers a cost-effective method for collecting information about the nervous system.
Although specific data on side effects for this exact device is unavailable, similar devices have been used without major safety issues. These devices typically gather information from the body without requiring surgery, making them generally well-tolerated by patients.
The trial's phase is "Not Applicable," indicating that the study focuses more on data collection than on testing safety. The technology in this device comes from well-known and trusted sources, supporting its safe use.
For those considering joining a trial with this device, the risks are likely low. However, discussing any concerns with the trial team is always advisable.12345Why are researchers excited about this trial?
Researchers are excited about the handheld point-of-care electro-diagnostic device because it offers a new way to diagnose neurological disorders quickly and efficiently. Unlike traditional diagnostic methods that often require complex equipment and lengthy testing in specialized facilities, this device is portable and can be used at the patient's location, potentially speeding up the diagnostic process. It aims to provide immediate, accurate data, allowing for faster treatment decisions and improving patient care. This innovation could revolutionize how neurological disorders are diagnosed, making the process more accessible and convenient.
What evidence suggests that this handheld diagnostic device is effective for neurological disorders?
Research has shown that handheld Point of Care (POC) devices can diagnose and treat brain and nerve conditions much faster. This speed is crucial because quicker treatment often leads to better health outcomes. In this trial, participants will undergo evaluation using a handheld POC electro-diagnostic device to compare its diagnostic data with clinical diagnostic data. One study found that POC-EEG devices, which monitor brain activity, were 97.4% accurate in identifying unusual brain patterns and 90.9% accurate in ruling them out. These devices were also 82.4% accurate in detecting Parkinson's Disease and 97.0% accurate in confirming its absence. This evidence suggests that these handheld devices can effectively diagnose and manage neurological conditions quickly.13678
Who Is on the Research Team?
Sergiu Abramovici, MD
Principal Investigator
Indiana University
Are You a Good Fit for This Trial?
This trial is for adults over 18 with neurological impairments who are seen at IU Health facilities. They must be able to consent or have a representative who can. Excluded are those with skin lesions, implanted stimulators, lacking standard imaging comparisons, severe illnesses as judged by the PI, or pregnant women.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are evaluated using the handheld POC device to compare diagnostic data collected vs. clinical diagnostic data
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Handheld Point of Care Electro-Diagnostic Device
Trial Overview
The study tests a handheld Point of Care (POC) electro-diagnostic device used by providers to gain immediate diagnostic insights for quicker treatment decisions in neurological conditions. It uses limited electrodes and stimulation modalities like SSEP, VEP, and BAEP.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will be evaluated using the handheld POC device to compare diagnostic data collected vs. clinical diagnostic data
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor
Citations
Handheld Point of Care Electro-Diagnostic Device
This can significantly shorten time to treatment which in several neurological and neurosurgical conditions, and thus, can significantly improve ...
Handheld Diagnostic Device for Neurological Disorders
Trial Overview The study tests a handheld Point of Care (POC) electro-diagnostic device used by providers to gain immediate diagnostic insights ...
Could a hand-held, visual electrophysiology device ...
Could a hand-held, visual electrophysiology device theoretically reduce diagnostic waiting times for complex eye conditions in the NHS?
4.
trial.medpath.com
trial.medpath.com/clinical-trial/d741369d4d887b75/nct07223827-handheld-point-of-care-electro-diagnostic-deviceHandheld Point of Care Electro-Diagnostic Device | MedPath
This can significantly shorten time to treatment which in several neurological and neurosurgical conditions, and thus, can significantly improve ...
Point-of-Care Electroencephalography in Acute ...
POC-EEG demonstrated a sensitivity of 97.4% and specificity of 90.9% for abnormal patterns, with PD detection showing 82.4% sensitivity and 97.0% specificity ...
Handheld Point of Care Electro-Diagnostic Device
The POC investigational electrodiagnostic prototype was assembled using OpenBCI8 electronic board and electrodes, based on ADS 129X chip by ...
Wearable devices in neurological disorders - PubMed Central
The data collected encompasses physiological, biochemical, and imaging information. Wearable devices are mainly utilized for health and safety ...
Automated Hand-Held Nerve Conduction Devices
The use of automated hand-held nerve conduction devices is among the newest and most controversial topics in the field of electrodiagnostic (EDX) medicine.
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