Normal Pressure Hydrocephalus, Normal Pressure Hydrocephalus Patients
Conditions
Keywords
Volumetry, Shunt obstruction, Shunt patency, NPH, Outcome
Brief summary
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.
Interventions
DEVICEIntervention group Virtual OFF
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.
DEVICEControl group (no change in shunt setting)
Patients randomized to continue their shunt setting unchanged
Sponsors
Department of Neurological Surgery, Sahlgrenska University Hospital
Hydrocephalus Research Unit, Sahlgrenska University Hospital
Department of Neurological Surgery, Linköping University Hospital
Department of Neurology, Linköping University Hospital
Göteborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Double-blinded randomized controlled study
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volumetry of CSF | 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
| Measure | Time frame | Description |
|---|---|---|
| Symptom burden | 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. 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood biomarker concentrations | 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. |
Contacts
Primary ContactDan Farahmand, MD, PhD
Backup ContactRebecca Grønning, MD
Outcome results
None listed