European Study of Prodromal iNPH

Launched by JOHAN VIRHAMMAR · Jun 17, 2023

Keywords

ClinConnect Summary

The European Study of Prodromal iNPH is a clinical trial aimed at understanding how a condition called normal pressure hydrocephalus (NPH) progresses from an early stage, known as prodromal, to a more severe stage where symptoms appear. Researchers want to find out if advanced brain scans and tests on fluid from the spine and blood can help predict this progression. The study will involve three groups of participants: those with early signs of NPH who don’t yet have serious symptoms, individuals who are already showing symptoms, and healthy volunteers. By observing these groups over time, both before and after a common treatment called shunt surgery, the researchers hope to uncover the reasons behind the worsening of this condition.

To be eligible for the study, participants in the prodromal group must have specific findings on brain scans but not show significant symptoms yet. They should also have a normal or slightly affected walking pattern and good cognitive function. Healthy volunteers need to be over 65 years old and free from certain neurological issues. Those in the symptomatic group must have a confirmed diagnosis of NPH and be of a similar age to the prodromal participants. Throughout the study, participants will undergo various tests but will not receive any treatment as part of the research process itself. This trial is important because it aims to improve our understanding of NPH and could lead to better ways to identify and treat this condition in the future.

Gender

ALL

Eligibility criteria

• • Inclusion criteria - Group 1 - prodromal iNPH
• * 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
• • Exclusion criteria - Group 1 - prodromal iNPH
• • 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
• • Inclusion criteria - Group 2 - healthy controls
• • • Age \> 65 years
• Exclusion criteria - Group 2 - healthy controls:
• • Imaging findings meet inclusion criteria of Group 1
• • Previously known relevant neurological disease
• • Pathological gait pattern with unknown reason.
• • MMSE \< 27 or MoCA \< 26.
• • Anticoagulants in a dose that hinders lumbar puncture
• • Inclusion criteria Group 3 symptomatic iNPH
• • iNPH diagnosis according to international guidelines.19
• • Age matched with the individual in Group 1 (+/- 3 years)
• • Exclusion criteria Group 3 symptomatic iNPH
• • Previous stroke (clinical stroke, not only radiologically verified)
• • Other serious disease with expected survival less than three years