Altered Mental StatusPhase 2NCT01671475
Putting Electroencephalography (EEG) in the Emergency Department
A Phase 2 study testing microEEG (Bio-Signal microEEG) in people with Altered Mental Status, run by Bio-Signal Group Corp. at 2 sites in United States.
Trial summary
The proposed study aims to test the impact of microEEG on clinical management (diagnosis and treatment) of emergency department patients with Altered Mental Status (AMS). The study will utilize a portable, wireless, FDA-approved device (microEEG) as the intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Altered Mental Status
- What is being tested?
- microEEG (Bio-Signal microEEG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2012to Dec 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ED patients ≥ 18 years old with AMS.
Who cannot join
- Patients with apparent and immediately correctable cause of AMS (determined by ED attending during initial evaluation) that include:
- Fingerstick or serum glucose less than 60mg/dl
- Hypothermia (Hypothermia is defined as any body temperature below 35.0 C [95.0 F]).
- Hyperthermia, heat exhaustion or heat stroke
- Opioid overdose responding to Narcan.
- Patients who cannot undergo EEG recordings for any reason (e.g. severe scalp injury).
Show all 11Show fewer
- Hemodynamically unstable patients(SBP <90mm Hg)
- Patients who are uncooperative or combative.
- Patients transferred out of ED before enrollment.
- Patients with obvious tonic-clonic or focal seizures in the ED.
- Note: Patients with hypoglycemia who do not return to their baseline level of mental status within 30 minutes of correcting their blood glucose level, will be enrolled. Similarly, patients who had an obvious seizure in the ED but do not return to their baseline mental status within 15 minutes will also be enrolled.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kings County Hospital Center
Brooklyn, New York, 11203
SUNY Downstate Medical Center
Brookyln, New York, 11203
About this study
Official title: Impact of microEEG on Clinical Management and Outcomes of Emergency Department (ED) Patients With Altered Mental Status
The proposed study aims to test the impact of microEEG on clinical management (diagnosis and treatment) of emergency department patients with Altered Mental Status (AMS). The study will utilize a portable, wireless, FDA-approved device (microEEG) as the intervention. Patients will be randomized to routine care plus microEEG (experimental arm) or routine care alone (control arm). The investigators hypothesize that incorporating microEEG in the work up of patients with AMS will impact the clinical management of these patients.
Read the detailed description
Approximately, 4% and 10% of emergency department (ED) patients in the United States present with altered mental status (AMS). According to previous studies, close to 30% of AMS cases occur due to neurological etiologies. Among these pathologies are non-convulsive seizures (NCS) and non-convulsive status epilepticus (NCSE). In our previous study, the investigators established that approximately 4% (95% confidence interval, 2-8%) of ED patients with AMS suffer from NCS and NCSE. Our study also revealed that 78% of the ED patient with AMS have some form of EEG abnormality.
NCS and NCSE are difficult to diagnose especially in AMS patients because performing a thorough physical examination or obtaining medical history is often impossible in altered patients. Definitive diagnosis of NCS/NCSE requires electroencephalography (EEG), a test that records brain electrical activity and provides information about the brain function.
Unfortunately, obtaining an EEG in the ED can be challenging. This requires transporting an EEG machine to patient's bedside, where space limitations and presence of variety of monitors and devices, especially in over-crowded EDs render this practice difficult. In many institutions an EEG service is not offered after work hours due to the unavailability of 24/7 EEG technologist coverage and real-time electroencephalographer interpretation. As a result of the aforementioned limitations, ED physicians may refrain from ordering EEG.
The wireless portable EEG device (microEEG) designed by the Bio-Signal Group was designed to address these limitations. With minimal training, ED personnel could use this small, microEEG device to obtain an EEG. The recording then can be wirelessly transmitted to a host computer via a secure network connection to the neurology experts who could interpret the EEG. Incorporating microEEG in the initial workup of patients with AMS could help the ED attending rule out NCS/NCSE and focus on other diagnoses. Alternatively, if the presence of NCS is confirmed by EEG, the treatment could be initiated early and potentially reduce morbidity or mortality.
The investigators hypothesize that incorporating EEG in the work of ED patients with AMS could impact the management(diagnosis and treatment)of these patients and influence their clinical outcome.
Sample size: Our sample size analysis using data one published related study reveled that the study would need 65 patients in each group (total n:130). However, the investigators plan to perform an interim analysis after enrolling half of this target sample and adjust the sample size calculation based on the collected data if necessary.
- Conditions
- Altered Mental Status
- Being tested
- microEEG (Bio-Signal microEEG)
- Keywords
- Altered Mental Status, Non-convulsive seizure, Electroencephalography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microEEG (Bio-Signal microEEG)Device
At the core, the Bio-Signal microEEG, is an FDA approved miniature, battery-operated, multi-channel, and portable system that records wideband bioelectric signals. The microEEG combines the characteristics of low noise and small size, due to a number of fundamental design characteristics. It records, amplifies, and digitizes the signals at a point very close to the electrodes. This allows the length of the wires between electrodes and the recorder's amplifiers to be very short, keeping them out of the way. Short wires also reduce any inconvenience signal artifacts or other problems that may be associated with the length of the wires. The microEEG's dimensions are about 2"x2"x1".
| Study group | Role | What they receive |
|---|---|---|
| Routine care plus microEEG | Experimental | Subjects allocated to this group will undergo an EEG using microEEG device in addition to their routine care. The microEEG device will be used with commercially available electrodes in a headpiece configuration. Receives: Device: microEEG (Bio-Signal microEEG) |
| Routine care only (control group) | No intervention | Subjects allocated to the control group will receive routine care without microEEG. The treating physician may request a standard EEG, which will be performed by the hospital EEG laboratory, if available. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of ED management
Primary outcome: Change in management (Diagnosis and Therapy)
Measured: 4-6 hours of arrival
Secondary outcomes (1)
Other Outcomes
Secondary Outcome: Length of stay in Hospital, Length of stay in ED, In-hospital mortality, Type of ED Disposition and Type of hospital disposition.
Measured: From date of randomization until the date of discharge from the hospital or date of in-hospital death from any cause, whichever comes first, assessed up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Altered Mental StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Signal Group Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), State University of New York - Downstate Medical Center, Kings County Hospital Center
- Responsible party
- Sponsor
- Investigators
- Shahriar Zehtabchi, MD, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671475
- Sponsor's protocol ID
- EDEEG
- Other IDs
- RC3NS070658
- Status last verified
- Feb 2013
- First submitted
- 4 Aug 2012
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zehtabchi S, Abdel Baki SG, Omurtag A, Sinert R, Chari G, Roodsari GS, Weedon J, Fenton AA, Grant AC. Effect of microEEG on clinical management and outcomes of emergency department patients with altered mental status: a randomized controlled trial. Acad Emerg Med. 2014 Mar;21(3):283-91. doi: 10.1111/acem.12324.
PubMed 24628753
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of microEEG on Clinical Management and Outcomes of Emergency Department (ED) Patients With Altered Mental Status
- ClinicalTrials.gov ID
- NCT01671475
- Acronym / sponsor ID
- EDEEG
- Conditions
- Altered Mental Status
- Keywords
- Altered Mental Status, Non-convulsive seizure, Electroencephalography
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Bio-Signal Group Corp.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), State University of New York - Downstate Medical Center, Kings County Hospital Center
- Study start
- Aug 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 23 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study aims to test the impact of microEEG on clinical management (diagnosis and treatment) of emergency department patients with Altered Mental Status (AMS). The study will utilize a portable, wireless, FDA-approved device (microEEG) as the intervention. Patients will be randomized to routine care plus microEEG (experimental arm) or routine care alone (control arm). The investigators hypothesize that incorporating microEEG in the work up of patients with AMS will impact the clinical management of these patients.
Detailed description
Approximately, 4% and 10% of emergency department (ED) patients in the United States present with altered mental status (AMS). According to previous studies, close to 30% of AMS cases occur due to neurological etiologies. Among these pathologies are non-convulsive seizures (NCS) and non-convulsive status epilepticus (NCSE). In our previous study, the investigators established that approximately 4% (95% confidence interval, 2-8%) of ED patients with AMS suffer from NCS and NCSE. Our study also revealed that 78% of the ED patient with AMS have some form of EEG abnormality.
NCS and NCSE are difficult to diagnose especially in AMS patients because performing a thorough physical examination or obtaining medical history is often impossible in altered patients. Definitive diagnosis of NCS/NCSE requires electroencephalography (EEG), a test that records brain electrical activity and provides information about the brain function.
Unfortunately, obtaining an EEG in the ED can be challenging. This requires transporting an EEG machine to patient's bedside, where space limitations and presence of variety of monitors and devices, especially in over-crowded EDs render this practice difficult. In many institutions an EEG service is not offered after work hours due to the unavailability of 24/7 EEG technologist coverage and real-time electroencephalographer interpretation. As a result of the aforementioned limitations, ED physicians may refrain from ordering EEG.
The wireless portable EEG device (microEEG) designed by the Bio-Signal Group was designed to address these limitations. With minimal training, ED personnel could use this small, microEEG device to obtain an EEG. The recording then can be wirelessly transmitted to a host computer via a secure network connection to the neurology experts who could interpret the EEG. Incorporating microEEG in the initial workup of patients with AMS could help the ED attending rule out NCS/NCSE and focus on other diagnoses. Alternatively, if the presence of NCS is confirmed by EEG, the treatment could be initiated early and potentially reduce morbidity or mortality.
The investigators hypothesize that incorporating EEG in the work of ED patients with AMS could impact the management(diagnosis and treatment)of these patients and influence their clinical outcome.
Sample size: Our sample size analysis using data one published related study reveled that the study would need 65 patients in each group (total n:130). However, the investigators plan to perform an interim analysis after enrolling half of this target sample and adjust the sample size calculation based on the collected data if necessary.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine care plus microEEG | Experimental | Device: microEEG (Bio-Signal microEEG)Subjects allocated to this group will undergo an EEG using microEEG device in addition to their routine care. The microEEG device will be used with commercially available electrodes in a headpiece configuration. |
| Routine care only (control group) | No intervention | –Subjects allocated to the control group will receive routine care without microEEG. The treating physician may request a standard EEG, which will be performed by the hospital EEG laboratory, if available. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ED patients ≥ 18 years old with AMS.
Key exclusion criteria (11 listed)
- Patients with apparent and immediately correctable cause of AMS (determined by ED attending during initial evaluation) that include:
- Patients who cannot undergo EEG recordings for any reason (e.g. severe scalp injury).
- Hemodynamically unstable patients(SBP <90mm Hg)
- Patients who are uncooperative or combative.
- Patients transferred out of ED before enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| microEEG (Bio-Signal microEEG)At the core, the Bio-Signal microEEG, is an FDA approved miniature, battery-operated, multi-channel, and portable system that records wideband bioelectric signals. The microEEG combines the characteristics of low noise and small size, due to a number of fundamental design characteristics. It records, amplifies, and digitizes the signals at a point very close to the electrodes. This allows the length of the wires between electrodes and the recorder's amplifiers to be very short, keeping them out of the way. Short wires also reduce any inconvenience signal artifacts or other problems that may be associated with the length of the wires. The microEEG's dimensions are about 2"x2"x1". | Device | Routine care plus microEEG |
Primary outcome
Change of ED management
Time frame: 4-6 hours of arrival
Primary outcome: Change in management (Diagnosis and Therapy)
1 secondary outcome
Other Outcomes
Time frame: From date of randomization until the date of discharge from the hospital or date of in-hospital death from any cause, whichever comes first, assessed up to 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
- Derived from this study: PubMed 24628753Zehtabchi S, Abdel Baki SG, Omurtag A, Sinert R, Chari G, Roodsari GS, Weedon J, Fenton AA, Grant AC. Effect of microEEG on clinical management and outcomes of emergency department patients with altered mental status: a randomized controlled trial. Acad Emerg Med. 2014 Mar;21(3):283-91. doi: 10.1111/acem.12324.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shahriar Zehtabchi, MD principal investigator
Physician
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing microEEG (Bio-Signal microEEG) in people with Altered Mental Status, run by Bio-Signal Group Corp. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of ED management (time frame: 4-6 hours of arrival). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01671475, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2013.