CPT-3 in Normal Pressure Hydrocephalus

NCT03521518 | Terminated DMC

• 1 other identifier: VR52393
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Normal Pressure Hydrocephalus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Attention and Responsiveness after Ventricular Peritoneal Shunt Placement

  Approximately 3-6 months after VPS placement

Interventions

Conner's Continuous Performance Test-3 DIAGNOSTIC_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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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").

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (4)

• 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.

  PMID: 5889177 BACKGROUND

• 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.

  PMID: 7062072 BACKGROUND

• 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.

  PMID: 26944123 BACKGROUND

• 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.

  PMID: 12438477 BACKGROUND

MeSH Terms

Conditions

Hydrocephalus, Normal Pressure

Condition Hierarchy (Ancestors)

Hydrocephalus; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• James E Eaton, MD

  Resident Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 28, 2018
• First Posted: May 11, 2018
• Study Start: January 16, 2019
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

US (1)