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

2 de setembro de 2026 atualizado por: Magnhild Skråmestø Dejgaard, Oslo University Hospital
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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Real)

276

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Oslo, Noruega
        • Department of Geriatric Medicine, Oslo University Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

see inclusion criteria

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Patients with idiopathic normal pressure hydrocephalus accepted for shunt 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Trail Making Test A (TMT A) from preoperative to postoperative in patients with idiopathic normal pressure hydrocephalus (iNPH).
Prazo: 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.
12 month
Change in Frailty Index (FI) from preoperative to postoperative in patients with idiopathic normal pressure hydrocephalus (iNPH).
Prazo: 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.
12 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Other measures of cognition and frailty
Prazo: 12 months
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.
12 months
Other measures of cognition and frailty
Prazo: 12 months
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.
12 months
Other measures of cognition and frailty
Prazo: 12 months
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.
12 months
Other measures of cognition and frailty
Prazo: 12 months
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.
12 months
Other measures of cognition and frailty
Prazo: 12 months

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.

12 months
Other measures of cognition and frailty
Prazo: 12 months
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.
12 months
Other measures of cognition and frailty
Prazo: 12 months
Trail Making Test B is a cognitive test assessing attention, psychomotor speed and executive function and is scored in seconds. MCID: 60 seconds.
12 months
Other measures of cognition and frailty
Prazo: 12 months
The Phonemic Fluency Test is a cognitive test assessing language abilities and executive function. Higher score reflects better performance. MCID:10 words.
12 months

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Responder analysis
Prazo: 12 months

Based on the MCID limits for each outcome, the investigators will define a responder for each outcome as a patient improving that much or more from the preoperative to the one-year postoperative assessment and will calculate the percentage of responders for each of the outcomes.

The investigators will then analyse predictors for shunt response on each of the ten outcome variables.

Candidate variables in the prediction models are:

1. Age. 2. Sex. 3. Education. 4. MMSE-NR3 score. 5. Gait speed. 6. FI score. 7. Difference in z-score between phonemic fluency and delayed recall at baseline. 8. Cluster affiliation (based on a previously published cluster analysis. The analytic strategy is described in detail in the Statistical Analysis Plan (SAP) that is uploaded as a separate document.

12 months

Colaboradores e Investigadores

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Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de setembro de 2018

Conclusão Primária (Real)

19 de junho de 2025

Conclusão do estudo (Real)

19 de junho de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

27 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de junho de 2026

Primeira postagem (Real)

11 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

8 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de setembro de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

The raw data supporting the conclsion of the article will be made available, following ethic committee guidelines on resonable request from any qualified investigators.

Critérios de acesso de compartilhamento IPD

Data sets are available from the PI on request.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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