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Analysis of Cerebrospinal Fluid Dynamics in Normal Pressure Hydrocephalus

ConditionNormal Pressure Hydrocephalus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-80
SponsorChungnam National University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Cerebrospinal fluid drainge

    Procedure/Surgery

    Cerebrospinal fluid drainge

Treatment groups

22 Participants
are divided into 1 treatment group
Group A: Cerebrospinal fluid draingeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chungnam National University Hospital

Lead sponsor

Source ClinicalTrials.gov
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