Actively Recruiting
European Study of Prodromal iNPH
Led by Johan Virhammar · Updated on 2026-04-30
140
Participants Needed
7
Research Sites
634 weeks
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
To investigate if progression from prodromal into symptomatic NPH can be predicted from advanced neuroimaging, biomarkers in cerebrospinal fluid (CSF) and plasma and investigate the unknown mechanisms causing deterioration by investigating longitudinal changes in the above-mentioned variables. Three different cohorts with both asymptomatic and symptomatic patients as well as healthy controls will be investigated over time, both without intervention and before and after shunt surgery.
CONDITIONS
Official Title
European Study of Prodromal iNPH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Brain imaging showing Evans index > 0.3 and callosal angle 64 90 degrees or features of disproportionately enlarged subarachnoid space hydrocephalus (DESH)
- Absence of symptoms or only mild symptoms not requiring shunt surgery
- Normal or slightly disturbed gait not caused by central nervous system disease
- Gait speed: men 65 1.4 m/s, women 65 1.25 m/s
- Romberg test with eyes open > 60 seconds
- Mini Mental State Examination (MMSE) 65 27 or Montreal Cognitive Assessment (MoCA) 65 23
- Provided informed consent
- For healthy controls: Age over 65 years
- For symptomatic iNPH group: diagnosis of iNPH per international guidelines and age matched (+/- 3 years) to prodromal group
You will not qualify if you...
- Contraindication for MRI
- Other serious diseases with expected survival less than three years
- Other types of hydrocephalus: non-communicating, secondary communicating, or suspected congenital hydrocephalus
- Use of anticoagulants that prevent lumbar puncture
- For healthy controls: imaging findings meeting prodromal criteria, known neurological disease, pathological gait of unknown cause, MMSE < 27 or MoCA < 26
- For symptomatic iNPH group: previous clinical stroke
AI-Screening
AI-Powered Screening
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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
CONTACT
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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