Non-invasive Diagnostics of Shunt Obstruction in Adult Hydrocephalus

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorGöteborg University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Unable to conform to instructions of the study

Trial design

Treatments tested in this trial

  • Intervention group "Virtual OFF"
  • Control group (no change in shunt setting)

Treatment groups

No treatment groups listed

Locations

This trial has no locations

Sponsors and collaborators

Göteborg University

Lead sponsor

Department of Neurological Surgery, Sahlgrenska University Hospital

Collaborator

Hydrocephalus Research Unit, Sahlgrenska University Hospital

Collaborator

Department of Neurological Surgery, Linköping University Hospital

Collaborator

Department of Neurology, Linköping University Hospital

Collaborator