Inpatients With Normal Neurological FunctionNCT01776086
Neuropsychological Testing Using Mobile Devices
A study testing Neurological testing in people with Inpatients With Normal Neurological Function, run by Englewood Hospital and Medical Center at 1 site in United States.
Trial summary
The purpose of this studying is to develop and characterize neuropsychological testing software for evaluating the prefrontal and temporal function of patients. As no software has been used for this purpose, this study will gather pilot data on the baseline performance of patients in a hospital setting that lack any… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inpatients With Normal Neurological Function
- What is being tested?
- Neurological testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Dec 2013
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inpatients > = 18 years of age
- Patient must be able to provide informed consent
Who cannot join
- Patients with score of < 26 on Folstein Mini-Mental Status Exam
- Patients with known brain lesions
- Patients with history of stroke, neurologic disease or dementia
- Patients with acute illness or who are in imminent distress
Trial locations and contacts
1 site in 1 country.
United States1 site
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631
About this study
The purpose of this studying is to develop and characterize neuropsychological testing software for evaluating the prefrontal and temporal function of patients. As no software has been used for this purpose, this study will gather pilot data on the baseline performance of patients in a hospital setting that lack any neurological impairment. After creating this baseline, later experiments can be proposed to compare the performance in normal subjects with those who have neurologic injury or disease.
- Being tested
- Neurological testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurological testingBehavioural
Also called Scenes Task, Folstein Mini-Mental Status Exam
| Study group | Role | What they receive |
|---|---|---|
| Normal patients | Other | for patients with normal score on neurological testing with Folstein Mini-Mental Status Exam will then take the Scenes Task Receives: Behavioral: Neurological testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of "normal performance" curve
The purpose of this study is to generate a curve of "normal performance" on the neurological test for hospitalized patients of different ages
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2013 (estimated)
- Study completionDec 2013 (estimated)
Why it stopped: no subjects agreed to participate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inpatients With Normal Neurological FunctionStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Englewood Hospital and Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Young, MD, PhD, Principal investigator, Englewood Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776086
- Sponsor's protocol ID
- E-12-471
- Status last verified
- Jul 2013
- First submitted
- 23 Jan 2013
- Last updated
- 10 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychological Testing Using Mobile Devices
- ClinicalTrials.gov ID
- NCT01776086
- Acronym / sponsor ID
- E-12-471
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no subjects agreed to participate
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Englewood Hospital and Medical CenterUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 25 Jan 2013 (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 purpose of this studying is to develop and characterize neuropsychological testing software for evaluating the prefrontal and temporal function of patients. As no software has been used for this purpose, this study will gather pilot data on the baseline performance of patients in a hospital setting that lack any neurological impairment. After creating this baseline, later experiments can be proposed to compare the performance in normal subjects with those who have neurologic injury or disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal patients | Other | Behavioral: Neurological testingfor patients with normal score on neurological testing with Folstein Mini-Mental Status Exam will then take the Scenes Task |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Inpatients > = 18 years of age
- Patient must be able to provide informed consent
Key exclusion criteria (4 listed)
- Patients with score of < 26 on Folstein Mini-Mental Status Exam
- Patients with known brain lesions
- Patients with history of stroke, neurologic disease or dementia
- Patients with acute illness or who are in imminent distress
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 |
|---|---|---|
| Neurological testingAlso: Scenes Task, Folstein Mini-Mental Status Exam | Behavioural | Normal patients |
Primary outcome
Determination of "normal performance" curve
Time frame: 1 year
The purpose of this study is to generate a curve of "normal performance" on the neurological test for hospitalized patients of different ages
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2013.
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.
James Young, MD, PhD principal investigator
Englewood Hospital and Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurological testing in people with Inpatients With Normal Neurological Function, run by Englewood Hospital and Medical Center at 1 site 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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 10 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Determination of "normal performance" curve (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2013.