Idiopathic Normal Pressure Hydrocephalus (INPH)NCT07642726
Change in Cognition and Frailty After Shunt Surgery in Idiopathic Normal Pressure Hydrocephalus (iNPH)
An observational study of Idiopathic Normal Pressure Hydrocephalus (INPH), run by Oslo University Hospital at 1 site in Norway.
Trial summary
The goal of this observational study is to describe changes in cognitive profile and frailty from pre shunt to one year after the shunt surgery and to identify clinical predictors of an improvement in terms of cognition and frailty during the same period. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Idiopathic Normal Pressure Hydrocephalus (INPH)
- What is being tested?
- Ventriculoperitoneal shunt
- Type of treatment
- Surgery or procedure
- How many people
- 276 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2018to 19 Jun 2025
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: see inclusion criteria
Who may be able to join
- Diagnosed with iNPH and accepted for shunt surgery according to the American-European guidelines at Department of Neurosurgery, Oslo University Hospital, Rikshospitalet.
Who cannot join
- Non-native speakers of Norwegian
- Patients who had completed ≤ 3 cognitive tests
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to describe changes in cognitive profile and frailty from pre shunt to one year after the shunt surgery and to identify clinical predictors of an improvement in terms of cognition and frailty during the same period. The main objective is to identify predictors of the effect on the planned shunt surgery on cognition and frailty.
Read the detailed description
Frailty is a consequence of cumulative decline in many physiological systems during a lifetime and implies an increased vulnerability to poor resolution of homoeostasis after a stressor event. Frailty is emerging as an important risk factor for mortality and postoperative complications but has to a limited degree been studied in iNPH.
The investigators have previously, in a cross-sectional design, described cognitive profile and frailty status in patients with iNPH accepted for shunt surgery at Oslo University Hospital. The aims of this longitudinal follow-up of the same patient cohort are twofold:
- to describe changes in cognitive profile and frailty from pre shunt to one year after the shunt surgery, and
- to identify clinical predictors of an improvement in terms of cognition and frailty during the same period.
The patient sample consists of 276 patients that were accepted for shunt surgery at Oslo University Hospital in the period from September 2018 to December 2023. Their mean age was 73.1 years (range 52-85), 61% were men, and their mean length of education was 12.5 years.
For frailty, the investigators used a 35 items Frailty Index (FI). Most of the items (frailty indicators) are scored 0 (not present) or 1 (present), while some of them have a graded score. The index is the sum score divided by the number of items, varying from 0.0 (no frailty) to 1.0 (extreme frailty). The investigators used the same approach for assessment of the degree of frailty within each frailty domain. Cognitive decline is considered as one component of frailty. Accordingly, the Mini Mental State Examination (MMSE) is part of the FI and has a graded score. MMSE sum score <21 gives a score of 1 at this particular FI item, an MMSE score of 21-23 gives an item score of 0.7, an MMSE score of 24-26 gives an item score of 0.3, whereas an MMSE score of 27-30 does not contribute to the FI. MMSE is a screening test covering several cognitive domains. The investigators will use MMSE to evaluate the cognitive dimension of frailty as described here, whereas more specific cognitive tests are utilised to assess failure in particular cognitive domains.
Preoperatively, the mean FI score was 0.23, and the most common frailty markers were in the domains of physical function and instrumental activities of daily living (iADL). On the group level, the iNPH patients were impaired on all cognitive domains preoperatively, but compared to patients with Alzheimer's disease, they had relatively better-preserved memory and more severe impairments in phonemic fluency.
224 (83%) patients were assessed one year postoperatively. The same cognitive tests and frailty assessments were carried out, making it possible to calculate simple change scores as score(postop) - score(preop). The investigators will compare baseline characteristics of patients lost to follow-up descriptively with those followed, to assess potential attrition bias.
A detailed Statistical Analysis Plan (SAP) describes the planned analytical approach.
- Being tested
- Ventriculoperitoneal shunt
- Keywords
- gait disorder, mild cognitive impairment, dementia, frailty, normative data
- Medical subject headings
- Mobility Limitation, Cognitive Dysfunction, Dementia, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventriculoperitoneal shuntProcedure or surgery
Patients are already accepted for shunt surgery. The investigators will describe changes in cognitve profile and frailty from pre shunt to one year after to identify clinical predictors for shunt response.
| Study group | Role | What they receive |
|---|---|---|
| Patients with idiopathic normal pressure hydrocephalus accepted for shunt surgery | Not described Receives: Procedure: Ventriculoperitoneal shunt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Trail Making Test A (TMT A) from preoperative to postoperative in patients with idiopathic normal pressure hydrocephalus (iNPH).
TMT A is a cognitive test assessing attention and psychomotor speed and is scored in seconds. The investigators have defined a Minimum Clinically Important Difference (MCID) as an improvement of 20 seconds.
Measured: 12 month
Change in Frailty Index (FI) from preoperative to postoperative in patients with idiopathic normal pressure hydrocephalus (iNPH).
For frailty, a 35 items FI was used. Most of the items (frailty indicators) are scored 0 (not present) or 1 (present), while some of them have a graded score. The index is the sum score divided by the numbers of items, varying from 0.0 (no frailty) to 1.0 (extreme frailty). The investigators have defined a Minimum Clinically Important Difference (MCID) as a decrease in the FI of 0.05 (5 %) or more.
Measured: 12 months
Secondary outcomes (8)
Other measures of cognition and frailty
Cognitive variables:
For assessing memory, delayed word recall is assessed using a normalized score ranging from 0 to 1. This score is derived from either the Ten-Word Test from Consortium to Establish a Registry for Alzheimer's disease (CERAD) or the Rey Auditory Learning Test. These scores are min/max normalized in order to achieve one common measure of delayed word recall: Normalized score = (raw score - lowest possible score)/(higest possible score - lowest possible score). The investigators have defined MCID of 0.2 words.
Measured: 12 months
Other measures of cognition and frailty
Figure Construction Test from CERAD is a cognitive test assessing visuoconstructive abilities and its scored from 0 to 11. Higher score reflects better performance. MCID: 2 points.
Measured: 12 months
Other measures of cognition and frailty
Trail Making Test B is a cognitive test assessing attention, psychomotor speed and executive function and is scored in seconds. MCID: 60 seconds.
Measured: 12 months
Other measures of cognition and frailty
The Phonemic Fluency Test is a cognitive test assessing language abilities and executive function. Higher score reflects better performance. MCID:10 words.
Measured: 12 months
Other measures of cognition and frailty
Mini Mental State Examination (MMSE-NR3) is a cognitive screening test from 0 - 30 covering several cognitive domains. Higher score indicates better function. MMSE is part of the FI and has a graded score. MMSE sum score <21 gives a score of 1 at this particular FI item, an MMSE score of 21-23 gives an item score of 0.7, an MMSE score of 24-26 gives an item score of 0.3, whereas an MMSE score of 27-30 does not contribute to the FI. MCID: 2 points.
Measured: 12 months
Other measures of cognition and frailty
Personal activities in daily living (pADL) are subscales of the FI and are scored from 0-7, higher score indicates more need for help in daily living. An improvement is set to at least 5 % for subscale as a limit for MCID.
Measured: 12 months
Other measures of cognition and frailty
Instrumental activities in daily living (iADL) are subscales of the FI and are scored from 0-7, higher score indicates more need for help in daily living. An improvement is set to at least 5 % for subscale as a limit for MCID.
Measured: 12 months
Other measures of cognition and frailty
Gait speed (m/s) is measured from 10 m walk and 0.1 m/s or more is accepted as clinically meaningful. MCID is set to 0.1 m/s.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Sep 2018
- Primary completion19 Jun 2025
- Study completion19 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Normal Pressure Hydrocephalus (INPH)Studies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magnhild Skråmestø Dejgaard, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642726
- Sponsor's protocol ID
- 10150 (formerly 2019/547)
- Other IDs
- Funded by
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The raw data supporting the conclsion of the article will be made available, following ethic committee guidelines on resonable request from any qualified investigators.
Publications
Dejgaard MS, Eide PK, Tangen GG, Skovlund E, Selbaek G, Wyller TB. Correction: Cognitive profile and frailty in patients with idiopathic normal pressure hydrocephalus. Front Neurol. 2025 Oct 13;16:1708210. doi: 10.3389/fneur.2025.1708210. eCollection 2025.
PubMed 41164400
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Cognition and Frailty After Shunt Surgery in Idiopathic Normal Pressure Hydrocephalus (iNPH)
- ClinicalTrials.gov ID
- NCT07642726
- Acronym / sponsor ID
- 10150 (formerly 2019/547)
- Keywords
- gait disorder, mild cognitive impairment, dementia, frailty, normative data
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 11 Jun 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.
The goal of this observational study is to describe changes in cognitive profile and frailty from pre shunt to one year after the shunt surgery and to identify clinical predictors of an improvement in terms of cognition and frailty during the same period. The main objective is to identify predictors of the effect on the planned shunt surgery on cognition and frailty.
Detailed description
Frailty is a consequence of cumulative decline in many physiological systems during a lifetime and implies an increased vulnerability to poor resolution of homoeostasis after a stressor event. Frailty is emerging as an important risk factor for mortality and postoperative complications but has to a limited degree been studied in iNPH.
The investigators have previously, in a cross-sectional design, described cognitive profile and frailty status in patients with iNPH accepted for shunt surgery at Oslo University Hospital. The aims of this longitudinal follow-up of the same patient cohort are twofold:
- to describe changes in cognitive profile and frailty from pre shunt to one year after the shunt surgery, and
- to identify clinical predictors of an improvement in terms of cognition and frailty during the same period.
The patient sample consists of 276 patients that were accepted for shunt surgery at Oslo University Hospital in the period from September 2018 to December 2023. Their mean age was 73.1 years (range 52-85), 61% were men, and their mean length of education was 12.5 years.
For frailty, the investigators used a 35 items Frailty Index (FI). Most of the items (frailty indicators) are scored 0 (not present) or 1 (present), while some of them have a graded score. The index is the sum score divided by the number of items, varying from 0.0 (no frailty) to 1.0 (extreme frailty). The investigators used the same approach for assessment of the degree of frailty within each frailty domain. Cognitive decline is considered as one component of frailty. Accordingly, the Mini Mental State Examination (MMSE) is part of the FI and has a graded score. MMSE sum score <21 gives a score of 1 at this particular FI item, an MMSE score of 21-23 gives an item score of 0.7, an MMSE score of 24-26 gives an item score of 0.3, whereas an MMSE score of 27-30 does not contribute to the FI. MMSE is a screening test covering several cognitive domains. The investigators will use MMSE to evaluate the cognitive dimension of frailty as described here, whereas more specific cognitive tests are utilised to assess failure in particular cognitive domains.
Preoperatively, the mean FI score was 0.23, and the most common frailty markers were in the domains of physical function and instrumental activities of daily living (iADL). On the group level, the iNPH patients were impaired on all cognitive domains preoperatively, but compared to patients with Alzheimer's disease, they had relatively better-preserved memory and more severe impairments in phonemic fluency.
224 (83%) patients were assessed one year postoperatively. The same cognitive tests and frailty assessments were carried out, making it possible to calculate simple change scores as score(postop) - score(preop). The investigators will compare baseline characteristics of patients lost to follow-up descriptively with those followed, to assess potential attrition bias.
A detailed Statistical Analysis Plan (SAP) describes the planned analytical approach.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with idiopathic normal pressure hydrocephalus accepted for shunt surgery | – | Procedure: Ventriculoperitoneal shunt |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- see inclusion criteria
Key inclusion criteria (1 listed)
- Diagnosed with iNPH and accepted for shunt surgery according to the American-European guidelines at Department of Neurosurgery, Oslo University Hospital, Rikshospitalet.
Key exclusion criteria (2 listed)
- Non-native speakers of Norwegian
- Patients who had completed ≤ 3 cognitive tests
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 |
|---|---|---|
| Ventriculoperitoneal shuntPatients are already accepted for shunt surgery. The investigators will describe changes in cognitve profile and frailty from pre shunt to one year after to identify clinical predictors for shunt response. | Procedure or surgery | Patients with idiopathic normal pressure hydrocephalus accepted for shunt surgery |
Primary outcome
Change in Trail Making Test A (TMT A) from preoperative to postoperative in patients with idiopathic normal pressure hydrocephalus (iNPH).
Time frame: 12 month
TMT A is a cognitive test assessing attention and psychomotor speed and is scored in seconds. The investigators have defined a Minimum Clinically Important Difference (MCID) as an improvement of 20 seconds.
Change in Frailty Index (FI) from preoperative to postoperative in patients with idiopathic normal pressure hydrocephalus (iNPH).
Time frame: 12 months
For frailty, a 35 items FI was used. Most of the items (frailty indicators) are scored 0 (not present) or 1 (present), while some of them have a graded score. The index is the sum score divided by the numbers of items, varying from 0.0 (no frailty) to 1.0 (extreme frailty). The investigators have defined a Minimum Clinically Important Difference (MCID) as a decrease in the FI of 0.05 (5 %) or more.
8 secondary outcomes
Other measures of cognition and frailty
Time frame: 12 months
Other measures of cognition and frailty
Time frame: 12 months
Other measures of cognition and frailty
Time frame: 12 months
Other measures of cognition and frailty
Time frame: 12 months
Other measures of cognition and frailty
Time frame: 12 months
Other measures of cognition and frailty
Time frame: 12 months
Other measures of cognition and frailty
Time frame: 12 months
Other measures of cognition and frailty
Time frame: 12 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 8 Sep 2026.
- Results publication: PubMed 41164400Dejgaard MS, Eide PK, Tangen GG, Skovlund E, Selbaek G, Wyller TB. Correction: Cognitive profile and frailty in patients with idiopathic normal pressure hydrocephalus. Front Neurol. 2025 Oct 13;16:1708210. doi: 10.3389/fneur.2025.1708210. eCollection 2025.
- Individual participant dataSharing planned: Yes. The raw data supporting the conclsion of the article will be made available, following ethic committee guidelines on resonable request from any qualified investigators.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Normal Pressure Hydrocephalus (INPH), run by Oslo University Hospital at 1 site in Norway.
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 1 inclusion and 2 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 8 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 Norway. 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?
Change in Trail Making Test A (TMT A) from preoperative to postoperative in patients with idiopathic normal pressure hydrocephalus (iNPH). (time frame: 12 month). The study lists 2 primary outcomes in all. 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 NCT07642726, which also lists 1 linked publication.
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 8 Sep 2026.