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

NCT07642726 | Completed

• 2 other identifiers: 10150 (formerly 2019/547)Funded by
• Study Type: observational
• Target: 276
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Normal Pressure Hydrocephalus (INPH)

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 z-scores are calculated using age and educational adjusted norms. The lowest/highest possible z-score is - 3/+ 3 and indicates - 3/+ 3 SD from the mean. Higher z-score reflects better performance. We have defined a Minimum Clinically Important Difference (MCID) as an increase in the z-score (number of standard deviations (SD)) from the age and education adjusted mean in a normative dataset of 0.5 or more for TMT A.

  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). We have defined a Minimum Clinically Important Difference (MCID) as a decrease in the FI of 0.05 (5 %) or more.

  12 months

Secondary Outcomes (8)

• Other measures of cognition and frailty

  12 months

• Other measures of cognition and frailty

  12 months

• Other measures of cognition and frailty

  12 months

• Other measures of cognition and frailty

  12 months

• Other measures of cognition and frailty

  12 months

Other Outcomes (1)

• Responder analysis

  12 months

Study Arms (1)

Patients with idiopathic normal pressure hydrocephalus accepted for shunt surgery

Procedure: Ventriculoperitoneal shunt

Interventions

Ventriculoperitoneal shunt PROCEDURE

Patients are already accepted for shunt surgery. We will describe changes in cognitve profile and frailty from pre shunt to one year after to identify clinical predictors for shunt response.

Patients with idiopathic normal pressure hydrocephalus accepted for shunt surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

see inclusion criteria

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Department of Geriatric Medicine, Oslo University Hospital

Oslo, Norway

Location

Related Publications (1)

• 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.

  PMID: 41164400 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples have been conducted at baseline.

MeSH Terms

Conditions

Mobility Limitation; Cognitive Dysfunction; Dementia; Frailty

Interventions

Ventriculoperitoneal Shunt

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Cerebrospinal Fluid Shunts; Anastomosis, Surgical; Surgical Procedures, Operative; Neurosurgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 11, 2026
• Study Start: September 1, 2018
• Primary Completion: June 19, 2025
• Study Completion: June 19, 2025
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Access Criteria: Data sets are available from the PI on request.

Locations

NO (1)