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NCT Number: NCT07831044

Analysis of Cerebrospinal Fluid Dynamics in Normal Pressure Hydrocephalus

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.

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Key information

Conditions

Normal Pressure Hydrocephalus Brain Diseases Central Nervous System Diseases Hydrocephalus Hydrocephalus, Normal Pressure Nervous System Diseases

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chungnam National University Hospital

Daejeon, Jung-gu, 35015, South Korea

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cerebrospinal fluid drainge

Procedure

Cerebrospinal fluid drainge

Primary outcomes

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

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

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

Secondary outcomes

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

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

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

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

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

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

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

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

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

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

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

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

Interested in participating?

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Interested in participating?

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Sponsors and collaborators

Lead sponsor

Chungnam National University Hospital

Other

Registry information

Official study title

Analysis of Cerebrospinal Fluid Dynamics in Patients With Normal Pressure Hydrocephalus Using Magnetic Resonance Imaging

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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