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NCT Number: NCT07172841

Non-invasive Diagnostics of Shunt Obstruction in Adult Hydrocephalus

The goal of this RCT is to test whether volumetric assessment of magnetic resonance imaging (MRI) could diagnose shunt obstruction in Adult Hydrocephalus patients, and in addition to explore correlations of blood biomarkers surrounding shunt obstruction. Thirdly to investigate correlations with clinical symptom burden before and after surgery.

The main questions it aims to answer are:

Can volumetric assessment of cerebrospinal fluid (CSF) aid in diagnosis of shunt obstruction? Are there dynamical changes in blood biomarker concentrations after shunt obstruction? How are clinical symptom burden and dynamics correlated with blood biomarker changes and volumetric changes in CSF?

After three months of shunt treatment, researchers will compare patients with "Virtual OFF" setting, to explore if simulated shunt obstruction affect measures mentioned above.

Participants randomized to the intervention group will undergo the 'Virtual OFF' setting for a period of 5-7 days, starting 3 months after initiation of shunt treatment. Symptom burden will be assessed preoperatively, at follow-up, and following the week of the shunt setting change. MRI scans will be conducted at these same time points. Participants in the control group will also meet with a nurse, but their shunt settings will remain unchanged. The control group will receive the same symptom assessments and MRI scans as the intervention group.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with normal pressure hydrocephalus (NPH)
  • Treated at either the Hydrocephalus Research Unit in Gothenburg or at the Department of Neurological Surgery at Linköping University Hospital or Sahlgrenska University Hospital

Exclusion criteria

  • Unable to conform to instructions of the study

Treatment and study plan

Intervention group "Virtual OFF"

Device

Patients randomized to shunt setting "Virtual Off" at the three month follow-up visit. After 5-7 days, the setting will be restored to the previous setting.

Control group (no change in shunt setting)

Device

Patients randomized to continue their shunt setting unchanged

Primary outcomes

  1. Volumetry of CSF

    Time frame: Preoperatively --> 3 months postop --> 3 months + 5-7 days postop

    Dynamics of volumetric assessment in lateral ventricles and subarachnoid space will be analyzed in groups as a primary outcome measure.

Secondary outcomes

  1. Symptom burden

    Time frame: Preoperatively --> 3 months postop --> 3 months + 5-7 days postop

    Results from 4 clinical tests and 2 self assessment forms will be collected preoperatively, 3 months postop and 3 months + 5-7 days postop. Dynamical changes in symptoms is considered a secondary outcome measure.

    • Walk-steps: number of steps on a 10 meter walk
    • Walk-time: number of seconds to walk 10 meters
    • Color naming test by Stroop
    • Grooved peg board test

    Self assessment of:

    • Balance
    • Urinary continence

Other outcomes

  1. Blood biomarker concentrations

    Time frame: Preoperatively (doctors appointment with diagnostics) --> 1 day preop --> 1 day postop --> 3 months postop --> 3 months + 7 days postop

    Concentrations of biomarkers S100B, GFAP, NFL och Tau will be collected, and their concentration changes could be considered an additional outcome measure.

Study contacts

Contact information is provided by the study sponsor or research team.

Dan Farahmand, MD, PhD

CONTACT

[email protected]

‭+46 31-342 96 28

Rebecca Grønning, MD

CONTACT

[email protected]

+46 722 224 776

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Department of Neurological Surgery, Linköping University Hospital
  • Department of Neurological Surgery, Sahlgrenska University Hospital
  • Department of Neurology, Linköping University Hospital
  • Hydrocephalus Research Unit, Sahlgrenska University Hospital

Registry information

Official study title

Randomized Controlled Study on Non-invasive Diagnostics of Shunt Obstruction in Adult Hydrocephalus

Important dates

Study start
2025
Primary completion
2028
Study completion
2034
First posted
Sep 15, 2025
Registry last updated
Sep 15, 2025

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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