Idiopathic Normal Pressure HydrocephalusiNPHNCT02495610
Novel Parameters for the Prediction of Ventriculoperitoneal Shunting Efficacy in Patients With iNPH
A study testing Gait analysis and MRI: in people with Idiopathic Normal Pressure Hydrocephalus, run by University of Zurich at 1 site in Switzerland.
Trial summary
INPH is a chronic, progressive disease characterised by enlarged ventricles in the absence of elevated intracranial pressure. Patients often present with the Hakim triad comprising gait disturbance, dementia and urinary incontinence. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Idiopathic Normal Pressure Hydrocephalus
- What is being tested?
- Gait analysis and MRI:
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2015to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent.
- Age 50 years or above
- Impaired walking function for at least 3 months, onset at/ after 40 years of age.
- MRI or CT with enlarged ventricular system (Evans' index ≥0.30) without evidence of moderate or severe cortical atrophy.
- Eligible for shunt surgery.
- Eligible for analysis of gait, neuropsychological and urological function.
- Subjects must be able to understand the patient information sheet and comply with the requirements of the protocol.
Who cannot join
- Previous intracranial disorder or surgery.
- Contraindications to surgery or MRI
- Contraindications to the testing of gait, bladder or neuropsychological function.
- Presence of concomitant disease which might reasonably account for the clinical symptoms or radiological findings.
- Worsening of walking function secondary to any other condition occurring during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Single-centre Trial Investigating Novel Parameters for the Prediction of Ventriculoperitoneal Shunting Efficacy in Patients With Idiopathic Normal Pressure Hydrocephalus
INPH is a chronic, progressive disease characterised by enlarged ventricles in the absence of elevated intracranial pressure. Patients often present with the Hakim triad comprising gait disturbance, dementia and urinary incontinence. Treatment consists of ventriculoperitoneal (VP) shunting reducing the cerebrospinal fluid (CSF) volume in the central nervous system (CNS); a generally safe and well tolerated procedure nevertheless invasive in nature and associated with surgical risk. The currently used diagnostic algorithms to predict surgery outcome by testing patients before and after a diagnostic spinal tap temporarily reducing the CSF volume in the CNS are of wide variability and limited validity. Developing measures to accurately diagnose and select patients for intervention is thus of great importance. The objective of this study is to define and validate a diagnostic algorithm for the selection of patients with symptoms compatible with iNPH for shunt surgery.
Read the detailed description
Idiopathic normal pressure hydrocephalus (iNPH) is an important differential diagnosis of dementia in the elderly patients. It is characterised by an enlargement of the ventricular system and can lead to cognitive deficits, gait disturbance and incontinence. Treatment consists of a ventriculoperitoneal shunt. A major challenge is the identification of patients who suffer from iNPH and who will benefit from shunt surgery. Typically, cerebrospinal fluid (CSF) is withdrawn by a spinal tap, and walking speed and steps per distance are measured before and thereafter. In patients who benefit from the test tap the diagnosis iNPH is made and the indication for shunt surgery is ascertained. The diagnostic procedure is not standardised.
Little is known about the examinations and time-points suited best to predict surgery outcome. Thus, patients may undergo surgery who do not benefit, and patients who would benefit may be missed.
This study aims at defining a diagnostic algorithm to improve the prediction of surgery outcome in patients supposed to suffer from iNPH. In 25 serial patients, motor function will be analysed in detail by functional tests and a treadmill-based analysis before and after the test tap at different time-points. In addition, neuropsychological tests and MRI investigations (DWI and pw) will be done, and patients will fill-out a micturition diary. Patients who do not respond to the test tap will be offered a lumbar drainage for continuous CSF release as diagnostic escalation with repeated tests thereafter. Patients who finally undergo shunt surgery will be re-assessed to identify those who responded to surgery. Thereby, post-hoc analyses will identify those parameter(s) that had the best predictive value for surgery outcome. To confirm the parameters derived from such exploratory analyses, these parameters will be validated in another series of 25 patients.
The results of this study have the potential to improve the clinical routine and to provide a strategic advantage for the University Hospital Zurich.
- Conditions
- Idiopathic Normal Pressure Hydrocephalus
- Being tested
- Gait analysis and MRI:
- Keywords
- NPH, Gait analysis, neuropsychology, micturition diary, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait analysis and MRI:Other
- Gait analysis: Treadmill with pressure sensors (FDM-THM-M-System; 'Zebris' medical GmbH), study-specific, but routine procedures.
- MRI: Performed in a scanner at the University Hospital with standard MRI compatibility procedures; study specific is only the additional MRI after the CSF release with spinal tap or drainage.
| Study group | Role | What they receive |
|---|---|---|
| Gait analysis and MRI | Other | * Gait analysis: Intervention: Treadmill with pressure sensors (FDM-THM-M-System (Force distribution method-treadmill); 'Zebris' medical GmbH), study-specific, but routine procedures.
* MRI: Intervention: Performed in a scanner at the University Hospital with standard MRI compatibility procedures; study specific is only the additional MRI after the CSF release with spinal tap or drainage. Receives: Other: Gait analysis and MRI: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Analysis on treadmill by foot print plate and overground walking by time keeping
a composite of the following measurements: Step width, step length, Foot rotation, double stance phase, cadence, velocity (Timed 25 Foot Walk, endurance (6 minute walking test)
Measured: 3 months
Secondary outcomes (3)
MRI
a composite of fractional anisotropy, mean diffusivity, parallel diffusivity, radial diffusivity
Measured: 3 months
Urological function by micturition diary
a composite of the following informations: number of voiding, number of incontinence episodes, number of urgency episodes
Measured: 3 months
Neuropsychology by validated testing
a composite of response inhibition and switching (stroop test), working memory (wechsler memory scale), verbal fluency (Regensburg word fluency), figural fluency (number of unique designs and repetitions of the same figure), divided and focused attention (TMT A, TMT B)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2024
- Study completionDec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Normal Pressure HydrocephalusStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Weller, Prof., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495610
- Sponsor's protocol ID
- KEK-ZH-Nr. 2014-0423
- Acronym
- iNPH
- Status last verified
- Apr 2026
- First submitted
- 23 Jun 2015
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Hakim S, Adams RD. The special clinical problem of symptomatic hydrocephalus with normal cerebrospinal fluid pressure. Observations on cerebrospinal fluid hydrodynamics. J Neurol Sci. 1965 Jul-Aug;2(4):307-27. doi: 10.1016/0022-510x(65)90016-x. No abstract available.
PubMed 5889177Marmarou A, Young HF, Aygok GA, Sawauchi S, Tsuji O, Yamamoto T, Dunbar J. Diagnosis and management of idiopathic normal-pressure hydrocephalus: a prospective study in 151 patients. J Neurosurg. 2005 Jun;102(6):987-97. doi: 10.3171/jns.2005.102.6.0987.
PubMed 16028756Relkin N, Marmarou A, Klinge P, Bergsneider M, Black PM. Diagnosing idiopathic normal-pressure hydrocephalus. Neurosurgery. 2005 Sep;57(3 Suppl):S4-16; discussion ii-v. doi: 10.1227/01.neu.0000168185.29659.c5.
PubMed 16160425Stolze H, Kuhtz-Buschbeck JP, Drucke H, Johnk K, Diercks C, Palmie S, Mehdorn HM, Illert M, Deuschl G. Gait analysis in idiopathic normal pressure hydrocephalus--which parameters respond to the CSF tap test? Clin Neurophysiol. 2000 Sep;111(9):1678-86. doi: 10.1016/s1388-2457(00)00362-x.
PubMed 10964082
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-centre Trial Investigating Novel Parameters for the Prediction of Ventriculoperitoneal Shunting Efficacy in Patients With Idiopathic Normal Pressure Hydrocephalus
- ClinicalTrials.gov ID
- NCT02495610
- Acronym / sponsor ID
- iNPH / KEK-ZH-Nr. 2014-0423
- Conditions
- Idiopathic Normal Pressure Hydrocephalus
- Keywords
- NPH, Gait analysis, neuropsychology, micturition diary, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Oct 2024 (actual)
- Study completion
- Dec 2024 (actual)
- First posted
- 13 Jul 2015 (estimated)
- 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.
INPH is a chronic, progressive disease characterised by enlarged ventricles in the absence of elevated intracranial pressure. Patients often present with the Hakim triad comprising gait disturbance, dementia and urinary incontinence. Treatment consists of ventriculoperitoneal (VP) shunting reducing the cerebrospinal fluid (CSF) volume in the central nervous system (CNS); a generally safe and well tolerated procedure nevertheless invasive in nature and associated with surgical risk. The currently used diagnostic algorithms to predict surgery outcome by testing patients before and after a diagnostic spinal tap temporarily reducing the CSF volume in the CNS are of wide variability and limited validity. Developing measures to accurately diagnose and select patients for intervention is thus of great importance. The objective of this study is to define and validate a diagnostic algorithm for the selection of patients with symptoms compatible with iNPH for shunt surgery.
Detailed description
Idiopathic normal pressure hydrocephalus (iNPH) is an important differential diagnosis of dementia in the elderly patients. It is characterised by an enlargement of the ventricular system and can lead to cognitive deficits, gait disturbance and incontinence. Treatment consists of a ventriculoperitoneal shunt. A major challenge is the identification of patients who suffer from iNPH and who will benefit from shunt surgery. Typically, cerebrospinal fluid (CSF) is withdrawn by a spinal tap, and walking speed and steps per distance are measured before and thereafter. In patients who benefit from the test tap the diagnosis iNPH is made and the indication for shunt surgery is ascertained. The diagnostic procedure is not standardised.
Little is known about the examinations and time-points suited best to predict surgery outcome. Thus, patients may undergo surgery who do not benefit, and patients who would benefit may be missed.
This study aims at defining a diagnostic algorithm to improve the prediction of surgery outcome in patients supposed to suffer from iNPH. In 25 serial patients, motor function will be analysed in detail by functional tests and a treadmill-based analysis before and after the test tap at different time-points. In addition, neuropsychological tests and MRI investigations (DWI and pw) will be done, and patients will fill-out a micturition diary. Patients who do not respond to the test tap will be offered a lumbar drainage for continuous CSF release as diagnostic escalation with repeated tests thereafter. Patients who finally undergo shunt surgery will be re-assessed to identify those who responded to surgery. Thereby, post-hoc analyses will identify those parameter(s) that had the best predictive value for surgery outcome. To confirm the parameters derived from such exploratory analyses, these parameters will be validated in another series of 25 patients.
The results of this study have the potential to improve the clinical routine and to provide a strategic advantage for the University Hospital Zurich.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gait analysis and MRI | Other | Other: Gait analysis and MRI:* Gait analysis: Intervention: Treadmill with pressure sensors (FDM-THM-M-System (Force distribution method-treadmill); 'Zebris' medical GmbH), study-specific, but routine procedures. * MRI: Intervention: Performed in a scanner at the University Hospital with standard MRI compatibility procedures; study specific is only the additional MRI after the CSF release with spinal tap or drainage. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed consent.
- Age 50 years or above
- Impaired walking function for at least 3 months, onset at/ after 40 years of age.
- MRI or CT with enlarged ventricular system (Evans' index ≥0.30) without evidence of moderate or severe cortical atrophy.
- Eligible for shunt surgery.
Key exclusion criteria (5 listed)
- Previous intracranial disorder or surgery.
- Contraindications to surgery or MRI
- Contraindications to the testing of gait, bladder or neuropsychological function.
- Presence of concomitant disease which might reasonably account for the clinical symptoms or radiological findings.
- Worsening of walking function secondary to any other condition occurring during the study.
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 |
|---|---|---|
| Gait analysis and MRI:* Gait analysis: Treadmill with pressure sensors (FDM-THM-M-System; 'Zebris' medical GmbH), study-specific, but routine procedures. * MRI: Performed in a scanner at the University Hospital with standard MRI compatibility procedures; study specific is only the additional MRI after the CSF release with spinal tap or drainage. | Other | Gait analysis and MRI |
Primary outcome
Gait Analysis on treadmill by foot print plate and overground walking by time keeping
Time frame: 3 months
a composite of the following measurements: Step width, step length, Foot rotation, double stance phase, cadence, velocity (Timed 25 Foot Walk, endurance (6 minute walking test)
3 secondary outcomes
MRI
Time frame: 3 months
Urological function by micturition diary
Time frame: 3 months
Neuropsychology by validated testing
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Background: PubMed 5889177Hakim S, Adams RD. The special clinical problem of symptomatic hydrocephalus with normal cerebrospinal fluid pressure. Observations on cerebrospinal fluid hydrodynamics. J Neurol Sci. 1965 Jul-Aug;2(4):307-27. doi: 10.1016/0022-510x(65)90016-x. No abstract available.
- Background: PubMed 16028756Marmarou A, Young HF, Aygok GA, Sawauchi S, Tsuji O, Yamamoto T, Dunbar J. Diagnosis and management of idiopathic normal-pressure hydrocephalus: a prospective study in 151 patients. J Neurosurg. 2005 Jun;102(6):987-97. doi: 10.3171/jns.2005.102.6.0987.
- Background: PubMed 16160425Relkin N, Marmarou A, Klinge P, Bergsneider M, Black PM. Diagnosing idiopathic normal-pressure hydrocephalus. Neurosurgery. 2005 Sep;57(3 Suppl):S4-16; discussion ii-v. doi: 10.1227/01.neu.0000168185.29659.c5.
- Background: PubMed 10964082Stolze H, Kuhtz-Buschbeck JP, Drucke H, Johnk K, Diercks C, Palmie S, Mehdorn HM, Illert M, Deuschl G. Gait analysis in idiopathic normal pressure hydrocephalus--which parameters respond to the CSF tap test? Clin Neurophysiol. 2000 Sep;111(9):1678-86. doi: 10.1016/s1388-2457(00)00362-x.
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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. This study is not recruiting at the moment.
Michael Weller, Prof. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait analysis and MRI: in people with Idiopathic Normal Pressure Hydrocephalus, run by University of Zurich at 1 site in Switzerland.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 30 Apr 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Analysis on treadmill by foot print plate and overground walking by time keeping (time frame: 3 months). 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 NCT02495610, which also lists 4 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 30 Apr 2026.