Normal Pressure HydrocephalusNCT07831044
Analysis of Cerebrospinal Fluid Dynamics in Normal Pressure Hydrocephalus
A study testing Cerebrospinal fluid drainge in people with Normal Pressure Hydrocephalus, run by Chungnam National University Hospital at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Normal Pressure Hydrocephalus
- What is being tested?
- Cerebrospinal fluid drainge
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Sep 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Chungnam National University Hospital
Daejeon, Jung-gu, 35015
Eungseok Oh, 82-42-280-7800, doctor_oh@daum.net
About this study
Official title: Analysis of Cerebrospinal Fluid Dynamics in Patients With Normal Pressure Hydrocephalus Using Magnetic Resonance Imaging
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.
- Conditions
- Normal Pressure Hydrocephalus
- Being tested
- Cerebrospinal fluid drainge
- Medical subject headings
- Hydrocephalus, Normal Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebrospinal fluid draingeProcedure or surgery
Cerebrospinal fluid drainge
| Study group | Role | What they receive |
|---|---|---|
| Cerebrospinal fluid drainge | Experimental | Not described Receives: Procedure: Cerebrospinal fluid drainge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Pre-intervention) and 30 minutes post-intervention
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 hours post-procedure, and 24 hours post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start11 Sep 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Normal Pressure HydrocephalusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chungnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee Jin Chang, Chungnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831044
- Sponsor's protocol ID
- 2025-06-077
- Status last verified
- Sep 2026
- First submitted
- 17 Mar 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 18282655Al-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 19388301Shanks 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 at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Cerebrospinal Fluid Dynamics in Patients With Normal Pressure Hydrocephalus Using Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT07831044
- Acronym / sponsor ID
- 2025-06-077
- Conditions
- Normal Pressure Hydrocephalus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Chungnam National University HospitalUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cerebrospinal fluid drainge | Experimental | Procedure: Cerebrospinal fluid drainge |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebrospinal fluid draingeCerebrospinal fluid drainge | Procedure or surgery | Cerebrospinal fluid drainge |
Primary outcome
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.
4 secondary outcomes
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Results publication: PubMed 18282655Sharma 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.
- Results publication: PubMed 19388301Al-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.
- Results publication: PubMed 30792248Shanks 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.
- Individual participant dataSharing planned: Undecided
Related trials for Normal Pressure Hydrocephalus
Not yet recruitingObservational study
Prediction of Response to Shunt Surgery in Normal Pressure Hydrocephalus Using Radscale and Lumbar Puncture
Idiopathic Normal Pressure Hydrocephalus, Normal Pressure Hydrocephalus
Active, not recruiting
Evaluation of the Safety and Effectiveness of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
Normal Pressure Hydrocephalus
Recruiting
Examining the Feasibility of Using Pressure Gradient Regulated Automated Cerebral Spinal Fluid Drainage During External Lumbar Drain Trials
NPH (Normal Pressure Hydrocephalus)
RecruitingObservational study
Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus
Hydrocephalus, Normal Pressure
RecruitingObservational study
Diagnostic Accuracy of ShuntCheck Compared to Radionuclide Shunt: Patency in Patients With Normal Pressure Hydrocephalus
Hydrocephalus, Normal Pressure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebrospinal fluid drainge in people with Normal Pressure Hydrocephalus, run by Chungnam National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eungseok Oh (82-42-280-7800, doctor_oh@daum.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07831044, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.