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Change in Cognition and Frailty After Shunt Surgery in Idiopathic Normal Pressure Hydrocephalus (iNPH)

Change in Cognition and Frailty After Shunt Surgery in Idiopathic Normal Pressure Hydrocephalus (iNPH)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07642726
Enrollment
276
Registered
2026-06-11
Start date
2018-09-01
Completion date
2025-06-19
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Normal Pressure Hydrocephalus (INPH)

Keywords

gait disorder, mild cognitive impairment, dementia, frailty, normative data

Brief 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. 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: 1. to describe changes in cognitive profile and frailty from pre shunt to one year after the shunt surgery, and 2. 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.

Interventions

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.

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

• Diagnosed with iNPH and accepted for shunt surgery according to the American-European guidelines at Department of Neurosurgery, Oslo University Hospital, Rikshospitalet.

Exclusion criteria

* Non-native speakers of Norwegian * Patients who had completed ≤ 3 cognitive tests

Design outcomes

Primary

MeasureTime frameDescription
Change in Trail Making Test A (TMT A) from preoperative to postoperative in patients with idiopathic normal pressure hydrocephalus (iNPH).12 monthTMT 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).12 monthsFor 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.

Secondary

MeasureTime frameDescription
Other measures of cognition and frailty12 monthsCognitive 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.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026