Normal Pressure Hydrocephalus Clinical Trial
Official title:
Neuropsychometric Testing With Conner's Continual Performance Test -3 in Normal Pressure Hydrocephalus
NCT number | NCT03521518 |
Other study ID # | VR52393 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | January 16, 2019 |
Est. completion date | June 1, 2023 |
Verified date | July 2023 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 8 |
Est. completion date | June 1, 2023 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center |
United States,
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. — View Citation
Kahlon 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. — View Citation
Mihalj 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. — View Citation
Wikkelso 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Attention and Responsiveness | 5% Improvement in T-scores of patients after large volume lumbar puncture | 1-3 hours after lumbar puncture, 2-3 days after lumbar puncture | |
Secondary | 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. | Approximately 3-6 months after VPS placement |
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