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RecruitingNCT07831044Updated Sep 21, 2026

Analysis of Cerebrospinal Fluid Dynamics in Normal Pressure Hydrocephalus

An interventional study of Cerebrospinal fluid drainge in Normal Pressure Hydrocephalus, sponsored by Chungnam National University Hospital. Recruiting at 1 site in South Korea. Open to participants aged 55 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Chungnam National University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Sep 2025, registered Mar 2026).
  • Started Sep 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
55 Years to 80 Years
Sex
All
01

Study summary

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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Conditions studied

  • Normal Pressure Hydrocephalus
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In context

Hydrocephalus, Normal Pressure

78 studies on the registry are indexed under Hydrocephalus, Normal Pressure; 20 are open to participants now.

This study's planned enrollment of 22 is below the median of 49 across 40 interventional studies indexed under Hydrocephalus, Normal Pressure.

Browse Hydrocephalus, Normal Pressure studies →

Lead sponsor

Chungnam National University Hospital is the lead sponsor of 20 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
55 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients who cannot undergo CSF drainage due to structural abnormalities of the lumbar spine
  • to lumbar puncture and CSF drainage (e.g., local infection at the puncture site, suspected elevated intracranial pressure, 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)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (estimated)

Study arms

  • Experimental
    Cerebrospinal fluid drainge

    Procedure: Cerebrospinal fluid drainge

Interventions

  • ProcedureCerebrospinal fluid drainge

    Cerebrospinal fluid drainge

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What researchers measure

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

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • Sharma AK, Gaikwad S, Gupta V, Garg A, Mishra NK. Measurement of peak CSF flow velocity at cerebral aqueduct, before and after lumbar CSF drainage, by use of phase-contrast MRI: utility in the management of idiopathic normal pressure hydrocephalus. Clin Neurol Neurosurg. 2008 Apr;110(4):363-8. doi: 10.1016/j.clineuro.2007.12.021. Epub 2008 Feb 20. PubMed 18282655 ↗
  • Al-Zain FT, Rademacher G, Meier U, Mutze S, Lemcke J. The role of cerebrospinal fluid flow study using phase contrast MR imaging in diagnosing idiopathic normal pressure hydrocephalus. Acta Neurochir Suppl. 2008;102:119-23. doi: 10.1007/978-3-211-85578-2_24. PubMed 19388301 ↗
  • Shanks J, Markenroth Bloch K, Laurell K, Cesarini KG, Fahlstrom M, Larsson EM, Virhammar J. Aqueductal CSF Stroke Volume Is Increased in Patients with Idiopathic Normal Pressure Hydrocephalus and Decreases after Shunt Surgery. AJNR Am J Neuroradiol. 2019 Mar;40(3):453-459. doi: 10.3174/ajnr.A5972. Epub 2019 Feb 21. PubMed 30792248 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07831044
Lead sponsor
Chungnam National University Hospital
Responsible party
Hee Jin Chang (Professor, Chungnam National University Hospital) — Principal investigator
First posted
Sep 21, 2026
Start date
Sep 11, 2025
Primary completion
Dec 2027 (estimated)
Completion
Dec 2028 (estimated)
Last update
Sep 21, 2026

Study contacts

Eungseok Oh
Contact
doctor_oh@daum.net
82-42-280-7800

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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