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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
60
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.
Patients randomized to continue their shunt setting unchanged
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 postop
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 postop
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