Analysis of Cerebrospinal Fluid Dynamics in Normal Pressure Hydrocephalus

Chungnam National University Hospital22 enrolled

Overview

This study aims to evaluate whether phase-contrast magnetic resonance imaging (MRI)-based cerebrospinal fluid (CSF) flow dynamics can improve the diagnosis and prognostic assessment of normal pressure hydrocephalus (NPH). In addition, the study investigates how changes in CSF flow parameters before and after CSF diversion procedures are associated with clinical improvement.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Normal Pressure Hydrocephalus

Interventions

Cerebrospinal fluid draingePROCEDURE

Cerebrospinal fluid drainge

Eligibility

Sex: ALLMin age: 55 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients presenting with clinical symptoms consistent with normal pressure hydrocephalus (presence of gait disturbance accompanied by at least one of the following: cognitive impairment or urinary dysfunction) * Evans' ratio ≥ 0.3 on brain MRI Exclusion Criteria: * Patients who cannot undergo CSF drainage due to structural abnormalities of the lumbar spine * Contraindications to lumbar puncture and CSF drainage (e.g., local infection at the puncture site, suspected elevated intracranial pressure, platelet count \< 40,000/µL, or coagulopathy) * Coexisting neurological disorders that can also cause gait disturbance, such as Parkinson's disease, atypical parkinsonian syndromes, or vascular parkinsonism * Contraindications to MRI (e.g., presence of cardiac pacemakers, implantable defibrillators, or other non-MRI-compatible implantable medical devices)

Locations (1)

Chungnam National University Hospital

Daejeon, Jung-gu, South Korea

RECRUITING

Outcomes

Primary Outcomes

Change from Baseline in Cerebrospinal Fluid Flow Velocity (cm/s) at 30 Minutes Post-Procedure

Assessment of cerebrospinal fluid flow parameters before and after the procedure.

Time frame: Baseline (Pre-intervention) and 30 minutes post-intervention

Secondary Outcomes

Change from Baseline in 10-Meter Walk Test (10MWT) Time at 6 Hours and 24 Hours Post-Procedure

Completion time during the 10-meter walk test, measured in seconds.

Time frame: Baseline, 6 hours post-procedure, and 24 hours post-procedure

Change from Baseline in 10-Meter Walk Test Step Count at 6 Hours and 24 Hours Post-Procedure

Number of steps taken during the 10-meter walk test, measured in steps.

Time frame: Baseline, 6 hours post-procedure, and 24 hours post-procedure

Change from Baseline in Timed Up and Go (TUG) Test Time at 6 Hours and 24 Hours Post-Procedure

Completion time during the 3-meter TUG test, measured in seconds.

Time frame: Baseline, 6 hours post-procedure, and 24 hours post-procedure

Change from Baseline in Cognitive Timed Up and Go (Cognitive TUG) Test Time at 6 Hours and 24 Hours Post-Procedure

Completion time during the 3-meter Cognitive TUG test while performing a dual task, measured in seconds.

Time frame: Baseline, 6 hours post-procedure, and 24 hours post-procedure

Central Contacts

Eungseok Oh

CONTACT

82-42-280-7800 doctor_oh@daum.net

Data from ClinicalTrials.gov

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