Actively Recruiting
European Study of Prodromal iNPH Investigating Progression and Outcomes Using Neuroimaging, Biomarkers and Shunt Surgery
Led by Johan Virhammar · Updated on 2026-04-30
140
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
Sponsors
J
Johan Virhammar
Lead Sponsor
S
Swedish Society for Medical Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying Normal Pressure Hydrocephalus (NPH), focusing on the early stage called prodromal iNPH, to understand how it progresses into symptomatic NPH. The study aims to predict this progression by using advanced brain imaging and analyzing biomarkers found in cerebrospinal fluid (CSF) and blood plasma. It will also explore the unknown processes causing deterioration in patients by tracking changes over time. The study involves three groups: patients with early signs but mild or no symptoms, healthy controls, and patients with symptomatic NPH. Participants in the prodromal group will undergo brain MRI scans, lumbar punctures to collect CSF, and blood samples at baseline and at regular intervals over up to six years. Their symptoms will be assessed repeatedly, especially if they progress and require shunt surgery. Healthy controls will follow the same assessment schedule but only for one cycle up to four years. Symptomatic patients will be age-matched and followed for five years after shunt surgery with clinical evaluations and blood tests. Throughout the study, participants will have multiple visits for symptom assessments, imaging, and sample collections. Researchers will measure outcomes such as the frequency of progression to symptomatic NPH requiring surgery, changes in brain structure, biomarker levels, and quality of life. Post-operative improvements in symptoms will also be tracked over five years. The total participation duration varies depending on group assignment and progression of symptoms.
CONDITIONS
Brief Title
European Study of Prodromal iNPH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Brain imaging with Evans index > 0.3 and callosal angle ≤ 90° or signs of disproportionately enlarged subarachnoid space hydrocephalus (DESH)
- No or very mild symptoms not requiring shunt surgery
- Normal or slightly disturbed gait not caused by central nervous system disease
- Gait speed ≥ 1.4 m/s for men, ≥ 1.25 m/s for women
- Romberg test with eyes open > 60 seconds
- Mini Mental State Examination (MMSE) ≥ 27 or Montreal Cognitive Assessment (MoCA) ≥ 23
- Informed consent
- Age over 65 years for healthy controls
- Diagnosis of iNPH according to international guidelines for symptomatic group
- Age matched with prodromal group (+/- 3 years) for symptomatic group
You will not qualify if you...
- Contraindication for MRI
- Serious disease with expected survival less than three years
- Other types of hydrocephalus (non-communicating, secondary communicating, suspected congenital)
- Use of anticoagulants that prevent lumbar puncture
- Imaging findings meeting Group 1 inclusion criteria for healthy controls
- Known neurological disease for healthy controls
- Pathological gait of unknown cause for healthy controls
- MMSE < 27 or MoCA < 26 for healthy controls
- Previous clinical stroke for symptomatic group
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 years
Participants with prodromal iNPH are followed with repeated assessments including symptoms, MRI of the brain, cerebrospinal fluid and blood samples to monitor progression until they develop symptoms requiring shunt surgery or choose to leave the study.
Visits at baseline, 6 months, 1 year, 2 years, 4 years, and 6 years
Duration - 4 years
Healthy controls are observed with assessments similar to the prodromal group over one cycle from baseline to year 4.
Visits at baseline, 6 months, 1 year, 2 years, and 4 years
Duration - Initial post-operative period
Participants who develop symptoms undergo shunt surgery according to local center routines followed by clinical evaluations and blood sample collections.
Surgery visit plus follow-up visits
Duration - 5 years
Patients who have had shunt surgery are followed with clinical evaluations and blood sample collections over five years to assess outcomes and recovery.
Approximately 4 post-operative visits during 5 years
Duration - 5 years
Patients with symptomatic iNPH are observed with post-operative routine assessments over five years following shunt surgery.
Approximately 4 post-operative visits during 5 years
Trial Site Locations
Total: 7 locations
1
Kuopio University Hospital
Kuopio, Finland
Not Yet Recruiting
2
Bellaria Hospital
Bologna, Italy
Actively Recruiting
3
Sahlgrenska University Hospital
Gothenburg, Sweden
Not Yet Recruiting
4
Linköping University Hospital
Linköping, Sweden
Not Yet Recruiting
5
Karolinska University Hospital
Stockholm, Sweden
Not Yet Recruiting
6
Umeå University Hospital
Umeå, Sweden
Not Yet Recruiting
7
Uppsala University Hospital
Uppsala, Sweden
Actively Recruiting
Research Team
J
Johan Virhammar, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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