- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07642726
Change in Cognition and Frailty After Shunt Surgery in Idiopathic Normal Pressure Hydrocephalus (iNPH)
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Yhteystiedot ja paikat
Opiskelupaikat
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Oslo, Norja
- Department of Geriatric Medicine, Oslo University Hospital
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
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Patients with idiopathic normal pressure hydrocephalus accepted for shunt surgery
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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.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in Trail Making Test A (TMT A) from preoperative to postoperative in patients with idiopathic normal pressure hydrocephalus (iNPH).
Aikaikkuna: 12 month
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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.
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12 month
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Change in Frailty Index (FI) from preoperative to postoperative in patients with idiopathic normal pressure hydrocephalus (iNPH).
Aikaikkuna: 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.
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12 months
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Other measures of cognition and frailty
Aikaikkuna: 12 months
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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.
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12 months
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Other measures of cognition and frailty
Aikaikkuna: 12 months
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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.
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12 months
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Other measures of cognition and frailty
Aikaikkuna: 12 months
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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.
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12 months
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Other measures of cognition and frailty
Aikaikkuna: 12 months
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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.
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12 months
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Other measures of cognition and frailty
Aikaikkuna: 12 months
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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
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Other measures of cognition and frailty
Aikaikkuna: 12 months
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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.
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12 months
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Other measures of cognition and frailty
Aikaikkuna: 12 months
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Trail Making Test B is a cognitive test assessing attention, psychomotor speed and executive function and is scored in seconds.
MCID: 60 seconds.
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12 months
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Other measures of cognition and frailty
Aikaikkuna: 12 months
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The Phonemic Fluency Test is a cognitive test assessing language abilities and executive function.
Higher score reflects better performance.
MCID:10 words.
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12 months
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Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Responder analysis
Aikaikkuna: 12 months
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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
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Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Aivojen sairaudet
- Keskushermoston sairaudet
- Hermoston sairaudet
- Mielenterveyshäiriöt
- Patologiset prosessit
- Neurokognitiiviset häiriöt
- Kognitiohäiriöt
- Patologiset tilat, merkit ja oireet
- Merkit ja oireet
- Hauras
- Kognitiivinen toimintahäiriö
- Liikkuvuuden rajoitus
- Dementia
- Kirurgiset toimenpiteet, operatiivinen
- Neurokirurgiset toimenpiteet
- Anastomoosi, kirurginen
- Aivo -selkäydinneste
- Vensiin
Muut tutkimustunnusnumerot
- 10150 (formerly 2019/547)
- Funded by (Muu tunniste: Department of Geriatric Medicine Oslo University Hospital)
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