MRI-Volumetry in the Evaluation of Shunt Treatment for Hydrocephalus

NCT04599153 | Completed

• 1 other identifier: Dnr 2017-254-31M
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydrocephalus, Normal Pressure

Keywords

Ventriculoperitoneal Shunt; cerebral ventricular volume; cerebrospinal fluid

Outcome Measures

Primary Outcomes (3)

• Ventricular volume at different shunt settings (mL)

  Change in ventricular volume (ml) measured by MRI

  Assessed before surgery and at one, two and, three months and three months plus one day post surgery.

• Time of "Timed Up and Go" test at different shunt settings

  Change in total walking time (sec) on "Timed Up and Go".

  Assessed before surgery and at one, two and, three months and three months plus one day post surgery.

• Time of 10m walking test at different shunt settings

  Change in total walking time (sec) on 10m walking test.

  Assessed before surgery and at one, two and, three months and three months plus one day post surgery.

Secondary Outcomes (27)

• Ventricular versus lumbar cerebrospinal fluid composition determined by mass spectrometry

  Cerebrospinal fluid is collected during diagnostic procedures before surgery, during surgery and three months and one day after surgery.

• Change in CSF composition after surgery determined by mass spectrometry

  Cerebrospinal fluid is collected during diagnostic procedures before surgery, during surgery and three months and one day after surgery.

• Number of steps of "Timed Up and Go" test at different shunt settings

  Assessed before surgery and at one, two and, three months and three months plus one day post surgery.

• Number of steps of "Timed Up and Go" test at different time points regardless of shunt setting

  Assessed before surgery and at one, two and, three months and three months plus one day post surgery.

• Number of steps on 10m walking test at different shunt settings

  Assessed before surgery and at one, two and, three months and three months plus one day post surgery.

Study Arms (2)

High initial

EXPERIMENTAL

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.

Other: Ventriculoperitoneal shunt opening pressure setting

Low initial

EXPERIMENTAL

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.

Other: Ventriculoperitoneal shunt opening pressure setting

Interventions

Ventriculoperitoneal shunt opening pressure setting 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.

High initial; Low initial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Neurology Clinic, Östersund Hospital

Östersund, Jämtland County, 83183, Sweden

Location

Related Publications (1)

• 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.

  PMID: 37976516 DERIVED

MeSH Terms

Conditions

Hydrocephalus, Normal Pressure

Condition Hierarchy (Ancestors)

Hydrocephalus; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Katarina Laurell, MD, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Shunt setting at the two months and three months follow up.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer/Associate Professor

Model Details: Randomized, double blinded crossover design.

Study Record Dates

• First Submitted: July 19, 2020
• First Posted: October 22, 2020
• Study Start: October 10, 2017
• Primary Completion: October 28, 2021
• Study Completion: October 28, 2021
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)