European Study of Prodromal iNPH
Johan Virhammar
140 participants
Nov 1, 2023
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria17
- Brain imaging with both:
- Evans index \> 0.3
- Callosal angle ≤ 90 º or:
- Disproportionately enlarged subarachnoid space hydrocephalus (DESH) - defined as: enlarged ventricles, dilated sylvian fissures and tight sulci at the high convexity.
- Absence of symptoms or too mild symptoms to motivate shunt surgery according to local routine, and all of the following:
- Normal gait pattern, or slight disturbance of the gait pattern that is not considered to be caused by a disease in the central nervous system (CNS).
- Gait velocity (maximum gait speed), men ≥ 1.4 m/s; women ≥ 1.25 m/s.
- Rombergs test with eyes open \> 60 seconds
- Mini Mental State Examination (MMSE) ≥ 27 or Montreal Cognitive Assessment (MoCA) ≥ 23
- Informed consent
- • Age \> 65 years
- Previously known relevant neurological disease
- Pathological gait pattern with unknown reason.
- MMSE \< 27 or MoCA \< 26.
- Anticoagulants in a dose that hinders lumbar puncture
- iNPH diagnosis according to international guidelines.19
- Age matched with the individual in Group 1 (+/- 3 years)
Exclusion Criteria9
- Contraindication for MRI
- Other serious disease with expected survival less than three years
- Other type of hydrocephalus:
- non-communicating hydrocephalus
- secondary communicating hydrocephalus
- suspected congenital hydrocephalus (severely enlarged ventricles, narrow sylvian fissures and normal non-compressed sulci at the high convexity or morphological findings consistent with PaVM18)
- Anticoagulants in a dose that hinders lumbar puncture
- Previous stroke (clinical stroke, not only radiologically verified)
- Other serious disease with expected survival less than three years
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Interventions
Shunt surgery according to each local centers routine
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT05910944