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NCT Number: NCT04599153

MRI-Volumetry in the Evaluation of Shunt Treatment for Hydrocephalus

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.

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Key information

Conditions

Hydrocephalus, Normal Pressure Brain Diseases Central Nervous System Diseases Hydrocephalus Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neurology Clinic, Östersund Hospital

Östersund, Jämtland County, 83183, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Ventricular volume at different shunt settings (mL)

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

    Change in ventricular volume (ml) measured by MRI

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

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

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

  3. Time of 10m walking test at different shunt settings

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

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

Secondary outcomes

  1. Ventricular versus lumbar cerebrospinal fluid composition determined by mass spectrometry

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

    Change in CSF composition from ventricular versus lumbar collection sites. Quantified with mass spectrometry and statistically compared on a protein by protein basis.

  2. Change in CSF composition after surgery determined by mass spectrometry

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

    Change in CSF composition before versus after surgery. Quantified with mass spectrometry and statistically compared on a protein by protein basis.

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

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

    Change in number of steps on "Timed Up and Go" test.

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

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

    Change in number of steps on "Timed Up and Go" test.

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

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

    Change in number of steps on 10m walking test.

  6. Number of steps on 10m walking test at different time points regardless of shunt setting

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

    Change in number of steps on 10m walking test.

  7. Time of 3m backwards walking test at different shunt settings

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

    Change in total walking time (sec) on 3m backwards walking test.

  8. Time of 3m backwards walking test at different time points regardless of shunt setting

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

    Change in total walking time (sec) on 3m backwards walking test.

  9. Number of steps on 3m backwards walking test at different shunt settings

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

    Change in number of steps on 3m backwards walking test.

  10. Number of steps on 3m backwards walking test at different time points regardless of shunt setting

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

    Change in number of steps on 3m backwards walking test.

  11. Mini Mental State Examination at different shunt settings

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

    Change in Mini Mental State Examination results. (min 0, max 30, higher is better)

  12. Mini Mental State Examination at different time points regardless of shunt setting

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

    Change in Mini Mental State Examination results. (min 0, max 30, higher is better)

  13. Epworth sleepiness scale at different time points regardless of shunt setting

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

    Change in Epworth sleepiness scale rating. (min 0, max 24, lower is better)

  14. Epworth sleepiness scale at different shunt settings

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

    Change in Epworth sleepiness scale rating. (min 0, max 24, lower is better)

  15. Continence scale at different time points regardless of shunt setting

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

    Change in continence scale rating. (min 1, max 6, lower is better)

  16. Continence scale at different shunt settings.

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

    Change in continence scale rating. (min 1, max 6, lower is better)

  17. Balance scale at different shunt settings.

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

    Change in Balance scale rating. (min 1, max 7, lower is better)

  18. Balance scale at different time points regardless of shunt setting

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

    Change in Balance scale rating. (min 1, max 7, lower is better)

  19. Modified rankin scale at different time points regardless of shunt setting

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

    Change in Modified rankin scale rating. (min 0, max 6, lower is better)

  20. Modified rankin scale at different shunt settings.

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

    Change in Modified rankin scale rating. (min 0, max 6, lower is better)

  21. Gray matter volume at different time points regardless of shunt setting

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

    Change in whole brain grey matter volume measured by MRI (mL).

  22. Gray matter volume at different shunt settings.

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

    Change in whole brain grey matter volume measured by MRI (mL).

  23. White matter volume at different time points regardless of shunt setting

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

    Change in whole brain white matter volume measured by MRI (mL).

  24. White matter volume at different shunt settings.

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

    Change in whole brain white matter volume measured by MRI (mL).

  25. Time of "Timed Up and Go" test at different time points regardless of shunt setting

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

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

  26. Time of 10m walking test at different time points regardless of shunt setting

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

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

  27. Ventricular volume at different time points regardless of shunt setting (mL)

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

    Change in ventricular volume (mL) measured by MRI

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

MRI-Volumetry in the Evaluation of Shunt Treatment for Hydrocephalus, a Randomised, Double-blind Study.

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Oct 22, 2020
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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