MRI-Volumetry in the Evaluation of Shunt Treatment for Hydrocephalus

NCT ID: NCT04599153

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-10
• Study Completion Date: 2021-10-28

Brief Summary

This randomized, double-blinded, cross-over study aim to evaluate the effects of shunt treatment in idiopathic normal pressure hydrocephalus (iNPH) by measuring cerebral ventricular volume and clinical symptoms at different shunt opening pressures. Further, proteins in the cerebrospinal fluid (CSF) will be compared before and after shunt surgery.

Detailed Description

The participants are evaluated before surgery and one month, two months, three months and three months plus one day after surgery. At each evaluation point a MRI of the brain with volumetric sequences is performed and clinical data is collected (Walking speed and steps for Time up and go, 10m walking and 3m walking backwards. Mini Mental State Examination, balance, gait, self rating of incontinence, Epworth Sleepiness Scale).

At surgery, all patients are given a ventriculoperitoneal (VP) shunt (Strata ® ) with an opening pressure setting of 1.5. After the first evaluation, one month postoperatively, participants are randomized to either a higher (2.5) or a lower (1.0) opening pressure, ratio 1:1. The opening pressure setting is blinded both for patients and the clinician during the subsequent clinical evaluations. At two months, the opening pressure is crossed over to the alternative setting (2.5 or 1.0). At three months, all participants receive the lowest shunt opening pressure (0.5) with the final evaluation the next day.

Semiautomatic measurement of the lateral as well as the third cerebral ventricles will be performed using the MRI scans and volumetric software: SyMRI (SyntheticMR AB, Linköping, Sweden)

CSF is collected at three times for each participant, from the lumbar spine pre- and 3 months postoperatively and intracranially during surgery. Further, intracranial CSF is taken through the Rickham Reservoir at the 3 months postoperative evaluation. After CSF from the participants has been collected, a single batch mass spectrometry will be performed with all the samples simultaneously.

Sample size was determined to achieve 80% power for a two tailed paired t-test for a mean change in ventricular volume of 8ml, estimated from postoperative change in ventricular volume in a previous study.

Hypotheses:

• The volume of the ventricular system in the brain decreases significantly after shunt-surgery.
• The ventricular volume is larger at high opening pressures compared to low opening pressures of the shunt.
• The decrease in ventricular volume is related to clinical outcome.

Conditions

Hydrocephalus, Normal Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

High initial

At the one month follow-up, the shunt is adjusted into a high opening pressure (2.5), which is crossed over to 1.0 at the two months follow-up. At the three months follow-up the opening pressure is set at 0.5 until the next day.

Group Type: EXPERIMENTAL

Ventriculoperitoneal shunt opening pressure setting

Intervention Type: OTHER

The ventriculoperitoneal shunt (Strata®) opening pressure can be changed using a magnetic tool. The possible settings are 0.5, 1.0, 1.5, 2.0, 2.5 with a higher setting number corresponding to a higher opening pressure and less drainage through the shunt. All settings are used in routine clinical practice.

Low initial

At the one month follow-up, the shunt is adjusted into a low opening pressure (1.0), which is crossed over to 2.5 at the two months follow-up. At the three months follow-up the opening pressure is set at 0.5 until the next day.

Group Type: EXPERIMENTAL

Ventriculoperitoneal shunt opening pressure setting

Intervention Type: OTHER

The ventriculoperitoneal shunt (Strata®) opening pressure can be changed using a magnetic tool. The possible settings are 0.5, 1.0, 1.5, 2.0, 2.5 with a higher setting number corresponding to a higher opening pressure and less drainage through the shunt. All settings are used in routine clinical practice.

Interventions

Ventriculoperitoneal shunt opening pressure setting

The ventriculoperitoneal shunt (Strata®) opening pressure can be changed using a magnetic tool. The possible settings are 0.5, 1.0, 1.5, 2.0, 2.5 with a higher setting number corresponding to a higher opening pressure and less drainage through the shunt. All settings are used in routine clinical practice.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis of idiopathic normal pressure hydrocephalus and planned treatment with shunt surgery.

Exclusion Criteria

• Ongoing anticoagulation treatment
• Ongoing Clopidogrel treatment
• Mini mental state examination results of 15 or lower.
• Contraindications to magnetic resonance imaging.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Katarina Laurell

Senior Lecturer/Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katarina Laurell, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

Neurology Clinic, Östersund Hospital

Östersund, Jämtland County, Sweden

Countries

Sweden

References

Liden S, Farahmand D, Laurell K. Volumetric effect of shunt adjustments in normal pressure hydrocephalus: a randomized, double-blind trial. J Neurosurg. 2023 Nov 17;140(5):1493-1500. doi: 10.3171/2023.9.JNS23668. Print 2024 May 1.

Reference Type: DERIVED

PMID: 37976516 (View on PubMed)

Other Identifiers

Dnr 2017-254-31M

Identifier Type: -

Identifier Source: org_study_id