Normal Pressure HydrocephalusNCT03521518
CPT-3 in Normal Pressure Hydrocephalus
An observational study of Normal Pressure Hydrocephalus, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The study will collect prospective cohort data of individuals that are undergoing routine clinical care for suspected idiopathic Normal Pressure Hydrocephalus (NPH). The administration of the Conner's Continual Performance Test - version 3 (CPT-3), an automated 14-minute computerized measure of reaction-time and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Normal Pressure Hydrocephalus
- What is being tested?
- Conner's Continuous Performance Test-3
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2019to 1 Jun 2023
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population will be adult patients with a clinical concern for Normal Pressure Hydrocephalus. They will be adults with cognitive impairment with at least one of the following: ventriculomegaly out of proportion to sulcal atrophy on imaging, urinary incontinence and problems with gait (magnetic gait or "apraxic gait").
Who may be able to join
- patients being referred for CSF tap test as part of routine clinical assessment of idiopathic Normal Pressure Hydrocephalus by their medical provider
- adults older than 18 years old
Who cannot join
- premorbid neurodegenerative disease (e.g. Alzheimer's Disease, Frontotemproal Dementia, Parkinson's Disease)
- serious acquired brain injury such as moderate to severe traumatic brain injury, large ischemic strokes
- seizure disorders
- serious neuropsychiatric disease (e.g. schizophrenia, bipolar disorder, major depressive disorder, active alcohol or drug abuse)
- untreated vitamin deficiencies (B12, Wernicke-Korsakoff Syndrome)
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Neuropsychometric Testing With Conner's Continual Performance Test -3 in Normal Pressure Hydrocephalus
The study will collect prospective cohort data of individuals that are undergoing routine clinical care for suspected idiopathic Normal Pressure Hydrocephalus (NPH). The administration of the Conner's Continual Performance Test - version 3 (CPT-3), an automated 14-minute computerized measure of reaction-time and sustained attention, will be added to the current neurocognitive screen being used (i.e., the Montreal Cognitive Assessment, MoCA) along with gait assessment. Patients will undergo pre-tap testing on the morning of their large volume Lumbar Puncture (CSF-TT). These patients will receive post-tap CPT-3 and MoCA testing one-to-three hours post-tap, and again at 2-3 days post-CSF-TT, during the follow-up appointment in clinic.
The standard NPH quantitative assessment methods of MoCA and gait evaluation will continue to be collected. For those patients that ultimately undergo ventricular shunt placement, the CPT-3 will be administered at their post-operative follow-up appointment (~3 months post-operation). The results of CPT-3 will not factor into consideration for shunt candidacy.
Read the detailed description
Normal pressure hydrocephalus (NPH) is a syndrome involving the clinical triad of gait disturbance, urinary incontinence, and cognitive dysfunction, in the context of ventricular enlargement out of proportion to parenchymal atrophy with normal intracranial pressure.
In the 1980's, a protocol for quantitative measurement of symptom response to large volume CSF tap (40-50ml) was developed, as a method for evaluating suitability for undergoing ventricular shunting surgery. A 2016 systematic review of the literature noted heterogeneous findings within the eight prospective cohort studies that were included in analysis, but concluded that there appeared to be support for the CSF-TT as a rule-in screen for response to shunt placement.
Unfortunately, no extant literature has analyzed the independent predictive power of a clinically significant reaction time improvement in response to CSF-TT (widely defined across the literature as 5% improvement) to subsequent response to ventricular shunting. This frustrates an a priori power analysis. However, a rough estimate was calculated based on data presented within one of the aforementioned reviewed studies that identified an improvement in reaction time in response to CSF-TT, as well as an improvement in reaction time to subsequent shunting.
The authors reported that 17 of 68 (25%) of the patients were labeled as positive-responders to CSF-TT, defined as meeting at least 2 of the following criteria: 1) 5% improvement in reaction time, 2) 5% improvement in gait (time or steps), 3) 25% improvement on visuospatial recall task, 4) 25% improvement on visuospatial recognition task. Of those 17 positive responders, 16 (94%) met the same positive-response criteria, post-shunting. If we use a 50% response rate as a proportion null hypothesis, this gives us a z-statistic = 3.63, or f2 = 3.71. G*Power analysis, for a 4-predictor regression (i.e., the aforementioned indicators used), estimates a necessary sample size of 16. The primary limitation of this approach is that it is unclear which of the 2+ positive response criteria were met. However, review of the pre- versus post-shunting data suggests reaction time was significantly improved (p<0.001; Cohen's d = 0.399), suggesting it is reasonable to infer the domain was favorably impacted by the temporary effects of a CSF-TT.
Patients will undergo pre-tap testing on the morning of their CSF-TT. The administration of the Conners Continual Performance Test - version 3 (CPT-3), an automated 14-minute computerized measure of reaction-time and sustained attention, will be added to the current neurocognitive screen being used (i.e., the Montreal Cognitive Assessment, MoCA). The current CSF-TT protocol's quantitative methods for measuring urinary incontinence and gait will continue to be collected. These patients will receive post-tap CPT-3 and MoCA testing one-to-three hours post-tap, and again at 2-3 days post-CSF-TT, during the follow-up appointment with Neurosurgery. For those that undergo ventricular shunt placement, the CPT-3 will be administered at their post-operative follow-up appointment (~3 months post-operation).
- Conditions
- Normal Pressure Hydrocephalus
- Being tested
- Conner's Continuous Performance Test-3
- Medical subject headings
- Hydrocephalus, Normal Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conner's Continuous Performance Test-3Diagnostic test
CPT-3 allows quantitative assessment of visuospatial, attention and reaction time in patients being evaluated for Normal Pressure Hydrocephalus undergoing a CSF tap test.
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention and Responsiveness
5% Improvement in T-scores of patients after large volume lumbar puncture
Measured: 1-3 hours after lumbar puncture, 2-3 days after lumbar puncture
Secondary outcomes (1)
Attention and Responsiveness after Ventricular Peritoneal Shunt Placement
Patients that have VPS placed will be reassessed and again will be looking for improvement in T-scores.
Measured: Approximately 3-6 months after VPS placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start16 Jan 2019
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Why it stopped: Inadequate enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Normal Pressure HydrocephalusStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Eaton, Vanderbilt University Medical Center
- Investigators
- James E Eaton, MD, Principal investigator, Resident Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521518
- Sponsor's protocol ID
- VR52393
- Status last verified
- Jul 2023
- First submitted
- 28 Apr 2018
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hakim S, Adams RD. The special clinical problem of symptomatic hydrocephalus with normal cerebrospinal fluid pressure. Observations on cerebrospinal fluid hydrodynamics. J Neurol Sci. 1965 Jul-Aug;2(4):307-27. doi: 10.1016/0022-510x(65)90016-x. No abstract available.
PubMed 5889177Wikkelso C, Andersson H, Blomstrand C, Lindqvist G. The clinical effect of lumbar puncture in normal pressure hydrocephalus. J Neurol Neurosurg Psychiatry. 1982 Jan;45(1):64-9. doi: 10.1136/jnnp.45.1.64.
PubMed 7062072Mihalj M, Dolic K, Kolic K, Ledenko V. CSF tap test - Obsolete or appropriate test for predicting shunt responsiveness? A systemic review. J Neurol Sci. 2016 Mar 15;362:78-84. doi: 10.1016/j.jns.2016.01.028. Epub 2016 Jan 22.
PubMed 26944123Kahlon B, Sundbarg G, Rehncrona S. Comparison between the lumbar infusion and CSF tap tests to predict outcome after shunt surgery in suspected normal pressure hydrocephalus. J Neurol Neurosurg Psychiatry. 2002 Dec;73(6):721-6. doi: 10.1136/jnnp.73.6.721.
PubMed 12438477
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychometric Testing With Conner's Continual Performance Test -3 in Normal Pressure Hydrocephalus
- ClinicalTrials.gov ID
- NCT03521518
- Acronym / sponsor ID
- VR52393
- Conditions
- Normal Pressure Hydrocephalus
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inadequate enrollment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 11 May 2018 (actual)
- 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 study will collect prospective cohort data of individuals that are undergoing routine clinical care for suspected idiopathic Normal Pressure Hydrocephalus (NPH). The administration of the Conner's Continual Performance Test - version 3 (CPT-3), an automated 14-minute computerized measure of reaction-time and sustained attention, will be added to the current neurocognitive screen being used (i.e., the Montreal Cognitive Assessment, MoCA) along with gait assessment. Patients will undergo pre-tap testing on the morning of their large volume Lumbar Puncture (CSF-TT). These patients will receive post-tap CPT-3 and MoCA testing one-to-three hours post-tap, and again at 2-3 days post-CSF-TT, during the follow-up appointment in clinic.
The standard NPH quantitative assessment methods of MoCA and gait evaluation will continue to be collected. For those patients that ultimately undergo ventricular shunt placement, the CPT-3 will be administered at their post-operative follow-up appointment (~3 months post-operation). The results of CPT-3 will not factor into consideration for shunt candidacy.
Detailed description
Normal pressure hydrocephalus (NPH) is a syndrome involving the clinical triad of gait disturbance, urinary incontinence, and cognitive dysfunction, in the context of ventricular enlargement out of proportion to parenchymal atrophy with normal intracranial pressure.
In the 1980's, a protocol for quantitative measurement of symptom response to large volume CSF tap (40-50ml) was developed, as a method for evaluating suitability for undergoing ventricular shunting surgery. A 2016 systematic review of the literature noted heterogeneous findings within the eight prospective cohort studies that were included in analysis, but concluded that there appeared to be support for the CSF-TT as a rule-in screen for response to shunt placement.
Unfortunately, no extant literature has analyzed the independent predictive power of a clinically significant reaction time improvement in response to CSF-TT (widely defined across the literature as 5% improvement) to subsequent response to ventricular shunting. This frustrates an a priori power analysis. However, a rough estimate was calculated based on data presented within one of the aforementioned reviewed studies that identified an improvement in reaction time in response to CSF-TT, as well as an improvement in reaction time to subsequent shunting.
The authors reported that 17 of 68 (25%) of the patients were labeled as positive-responders to CSF-TT, defined as meeting at least 2 of the following criteria: 1) 5% improvement in reaction time, 2) 5% improvement in gait (time or steps), 3) 25% improvement on visuospatial recall task, 4) 25% improvement on visuospatial recognition task. Of those 17 positive responders, 16 (94%) met the same positive-response criteria, post-shunting. If we use a 50% response rate as a proportion null hypothesis, this gives us a z-statistic = 3.63, or f2 = 3.71. G*Power analysis, for a 4-predictor regression (i.e., the aforementioned indicators used), estimates a necessary sample size of 16. The primary limitation of this approach is that it is unclear which of the 2+ positive response criteria were met. However, review of the pre- versus post-shunting data suggests reaction time was significantly improved (p<0.001; Cohen's d = 0.399), suggesting it is reasonable to infer the domain was favorably impacted by the temporary effects of a CSF-TT.
Patients will undergo pre-tap testing on the morning of their CSF-TT. The administration of the Conners Continual Performance Test - version 3 (CPT-3), an automated 14-minute computerized measure of reaction-time and sustained attention, will be added to the current neurocognitive screen being used (i.e., the Montreal Cognitive Assessment, MoCA). The current CSF-TT protocol's quantitative methods for measuring urinary incontinence and gait will continue to be collected. These patients will receive post-tap CPT-3 and MoCA testing one-to-three hours post-tap, and again at 2-3 days post-CSF-TT, during the follow-up appointment with Neurosurgery. For those that undergo ventricular shunt placement, the CPT-3 will be administered at their post-operative follow-up appointment (~3 months post-operation).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will be adult patients with a clinical concern for Normal Pressure Hydrocephalus. They will be adults with cognitive impairment with at least one of the following: ventriculomegaly out of proportion to sulcal atrophy on imaging, urinary incontinence and problems with gait (magnetic gait or "apraxic gait").
Key inclusion criteria (2 listed)
- patients being referred for CSF tap test as part of routine clinical assessment of idiopathic Normal Pressure Hydrocephalus by their medical provider
- adults older than 18 years old
Key exclusion criteria (5 listed)
- premorbid neurodegenerative disease (e.g. Alzheimer's Disease, Frontotemproal Dementia, Parkinson's Disease)
- serious acquired brain injury such as moderate to severe traumatic brain injury, large ischemic strokes
- seizure disorders
- serious neuropsychiatric disease (e.g. schizophrenia, bipolar disorder, major depressive disorder, active alcohol or drug abuse)
- untreated vitamin deficiencies (B12, Wernicke-Korsakoff Syndrome)
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 |
|---|---|---|
| Conner's Continuous Performance Test-3CPT-3 allows quantitative assessment of visuospatial, attention and reaction time in patients being evaluated for Normal Pressure Hydrocephalus undergoing a CSF tap test. | Diagnostic test | – |
Primary outcome
Attention and Responsiveness
Time frame: 1-3 hours after lumbar puncture, 2-3 days after lumbar puncture
5% Improvement in T-scores of patients after large volume lumbar puncture
1 secondary outcome
Attention and Responsiveness after Ventricular Peritoneal Shunt Placement
Time frame: Approximately 3-6 months after VPS placement
Results and safety
The study was stopped early (reason given: Inadequate enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Background: PubMed 5889177Hakim S, Adams RD. The special clinical problem of symptomatic hydrocephalus with normal cerebrospinal fluid pressure. Observations on cerebrospinal fluid hydrodynamics. J Neurol Sci. 1965 Jul-Aug;2(4):307-27. doi: 10.1016/0022-510x(65)90016-x. No abstract available.
- Background: PubMed 7062072Wikkelso C, Andersson H, Blomstrand C, Lindqvist G. The clinical effect of lumbar puncture in normal pressure hydrocephalus. J Neurol Neurosurg Psychiatry. 1982 Jan;45(1):64-9. doi: 10.1136/jnnp.45.1.64.
- Background: PubMed 26944123Mihalj M, Dolic K, Kolic K, Ledenko V. CSF tap test - Obsolete or appropriate test for predicting shunt responsiveness? A systemic review. J Neurol Sci. 2016 Mar 15;362:78-84. doi: 10.1016/j.jns.2016.01.028. Epub 2016 Jan 22.
- Background: PubMed 12438477Kahlon B, Sundbarg G, Rehncrona S. Comparison between the lumbar infusion and CSF tap tests to predict outcome after shunt surgery in suspected normal pressure hydrocephalus. J Neurol Neurosurg Psychiatry. 2002 Dec;73(6):721-6. doi: 10.1136/jnnp.73.6.721.
- Individual participant dataSharing planned: Undecided
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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.
James E Eaton, MD principal investigator
Resident Physician
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 Normal Pressure Hydrocephalus, run by Vanderbilt University 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 5 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 27 Jul 2023. 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: Inadequate enrollment). 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?
Attention and Responsiveness (time frame: 1-3 hours after lumbar puncture, 2-3 days after lumbar puncture). 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 NCT03521518, which also lists 4 linked publications.
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 27 Jul 2023.