Healthy ElderlyNCT01421446
Study to Validate a Computerized Neuropsychological Test Battery
An observational study of Healthy Elderly, run by LifeBridge Health at 1 site in United States.
Trial summary
This study is comparing a new computer-based method of administering neuropsychological tests to the standard method of verbal and paper/pencil tests administered in person by an examiner. The purpose of the research is to determine if the computerized and standard testing methods are equivalent. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Elderly
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Dec 2013
- Phase
- Observational
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy elderly subjects without significant neurologic, psychiatric, cardiovascular, or other systemic disease that impairs neurologic function or cognitive function
Who may be able to join
- Age 60-80
Who cannot join
- Neurological disorder that results in motor or cognitive dysfunction
- Perceptual or motor difficulties that would prevent subjects from taking the assessment
- MMSE score <20
- MoCA score <26
- MAS score >9
- Significant abnormal neurologic examination findings
Trial locations and contacts
1 site in 1 country.
United States1 site
Sandra and Malcolm Berman Brain & Spine Institute
Baltimore, Maryland, 21209
About this study
Official title: Reliability and Validity of Umea Computerized Neuropsychological Battery
This study is comparing a new computer-based method of administering neuropsychological tests to the standard method of verbal and paper/pencil tests administered in person by an examiner. The purpose of the research is to determine if the computerized and standard testing methods are equivalent.
Read the detailed description
Cognitive decline is one of the primary symptom triad of Normal Pressure Hydrocephalus (NPH). Neuropsychological measures have been demonstrated as being effective in the diagnosis of NPH, and in assessing the efficacy of treatment intervention. Hence, neuropsychological assessment is a critical component in the assessment for the presence of NPH. Specifically, measures of attention/concentration, fine motor skills, executive functioning abilities, speed of processing and memory have been found to be useful in the assessment of NPH and treatments thereof.
Neuropsychologists are typically found in large hospitals, academic centers and in urban locations. Neuropsychologists are under represented in rural or low population centers. At the present time, cognitive assessment is frequently limited to a Mini Mental Status Examination. Furthermore, neuropsychological testing can be very expensive for patients, given insurance constraints. Finally, there is no standardized test battery that is used in different centers treating this patient population. The creation of a standard battery that could be used in other NPH centers would promote research collaboration.
A computerized neuropsychological test battery was developed in Umea, Sweden with the specific goal of using tests that are considered to be sensitive to the cognitive profile observed in NPH. The battery was developed in JAVA and Adobe Flash making it platform independent (Runs on Mac, Windows and Linux). The test battery is administered on a touch screen display, where the tests are presented through animations with audio instructions. Before the real test trails are administered, subjects are given practice trials with auditory and visual feedback. For the American version of the test, the auditory stimuli have been translated and recorded in English.
- Conditions
- Healthy Elderly
- Keywords
- Neuropsychology
What is being measured
The primary outcome is the main question the study is designed to answer.
Computer Hydrocephalus Neuropsychological Assessment Versions 1 & 2
Measured: Within 2-5 weeks of enrollment
Standard Hydrocephalus Neuropsychological Assessment: Versions 1 & 2
Measured: Within 2-5 weeks of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2013
- Study completionDec 2013
Why it stopped: Insufficient subject recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ElderlyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeBridge Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Williams, LifeBridge Health
- Investigators
- Michael A Williams, MD, Principal investigator, LifeBridge Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421446
- Sponsor's protocol ID
- BSI-LBH 1735
- Status last verified
- Mar 2015
- First submitted
- 19 Aug 2011
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of Umea Computerized Neuropsychological Battery
- ClinicalTrials.gov ID
- NCT01421446
- Acronym / sponsor ID
- BSI-LBH 1735
- Conditions
- Healthy Elderly
- Keywords
- Neuropsychology
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient subject recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- LifeBridge HealthUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 22 Aug 2011 (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.
This study is comparing a new computer-based method of administering neuropsychological tests to the standard method of verbal and paper/pencil tests administered in person by an examiner. The purpose of the research is to determine if the computerized and standard testing methods are equivalent.
Detailed description
Cognitive decline is one of the primary symptom triad of Normal Pressure Hydrocephalus (NPH). Neuropsychological measures have been demonstrated as being effective in the diagnosis of NPH, and in assessing the efficacy of treatment intervention. Hence, neuropsychological assessment is a critical component in the assessment for the presence of NPH. Specifically, measures of attention/concentration, fine motor skills, executive functioning abilities, speed of processing and memory have been found to be useful in the assessment of NPH and treatments thereof.
Neuropsychologists are typically found in large hospitals, academic centers and in urban locations. Neuropsychologists are under represented in rural or low population centers. At the present time, cognitive assessment is frequently limited to a Mini Mental Status Examination. Furthermore, neuropsychological testing can be very expensive for patients, given insurance constraints. Finally, there is no standardized test battery that is used in different centers treating this patient population. The creation of a standard battery that could be used in other NPH centers would promote research collaboration.
A computerized neuropsychological test battery was developed in Umea, Sweden with the specific goal of using tests that are considered to be sensitive to the cognitive profile observed in NPH. The battery was developed in JAVA and Adobe Flash making it platform independent (Runs on Mac, Windows and Linux). The test battery is administered on a touch screen display, where the tests are presented through animations with audio instructions. Before the real test trails are administered, subjects are given practice trials with auditory and visual feedback. For the American version of the test, the auditory stimuli have been translated and recorded in English.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy elderly subjects without significant neurologic, psychiatric, cardiovascular, or other systemic disease that impairs neurologic function or cognitive function
Key inclusion criteria (1 listed)
- Age 60-80
Key exclusion criteria (6 listed)
- Neurological disorder that results in motor or cognitive dysfunction
- Perceptual or motor difficulties that would prevent subjects from taking the assessment
- MMSE score <20
- MoCA score <26
- MAS score >9
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Computer Hydrocephalus Neuropsychological Assessment Versions 1 & 2
Time frame: Within 2-5 weeks of enrollment
Standard Hydrocephalus Neuropsychological Assessment: Versions 1 & 2
Time frame: Within 2-5 weeks of enrollment
Results and safety
The study was stopped early (reason given: Insufficient subject recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
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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.
Michael A Williams, MD principal investigator
LifeBridge Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Elderly, run by LifeBridge Health 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 1 inclusion and 6 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: stopped early, as of the sponsor's last update on 1 Apr 2015. 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 stopped early (reason given: Insufficient subject recruitment). Results are not available in the source record.
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?
Computer Hydrocephalus Neuropsychological Assessment Versions 1 & 2 (time frame: Within 2-5 weeks of enrollment). The study lists 2 primary outcomes in all. 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 1 Apr 2015; AzTrials last refreshed its copy on 30 Oct 2026.