Non-invasive Diagnostics of Shunt Obstruction in Adult Hydrocephalus

Göteborg University

Status

Not yet enrolling

Conditions

Normal Pressure Hydrocephalus Patients

Normal Pressure Hydrocephalus

Treatments

Device: Intervention group "Virtual OFF"

Device: Control group (no change in shunt setting)

Study type

Interventional

Funder types

Other

Identifiers

NCT07172841

Dnr 2024-01568-01

Dnr: SU2024-06898 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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