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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Intervention group "Virtual OFF"
DevicePatients 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)
DevicePatients randomized to continue their shunt setting unchanged
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Volumetry of CSF
Dynamics of volumetric assessment in lateral ventricles and subarachnoid space will be analyzed in groups as a primary outcome measure.
Time frame
Preoperatively --> 3 months postop --> 3 months + 5-7 days postopSecondary outcomes
1
Symptom burden
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. 1. Walk-steps: number of steps on a 10 meter walk 2. Walk-time: number of seconds to walk 10 meters 3. Color naming test by Stroop 4. Grooved peg board test Self assessment of: 5. Balance 6. Urinary continence
Time frame
Preoperatively --> 3 months postop --> 3 months + 5-7 days postopOther outcomes
1
Blood biomarker concentrations
Concentrations of biomarkers S100B, GFAP, NFL och Tau will be collected, and their concentration changes could be considered an additional outcome measure.
Time frame
Preoperatively (doctors appointment with diagnostics) --> 1 day preop --> 1 day postop --> 3 months postop --> 3 months + 7 days postopLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov
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