Investigating early signs of Normal Pressure Hydrocephalus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to predict the progression from prodromal to symptomatic Normal Pressure Hydrocephalus (NPH) using advanced neuroimaging and biomarkers in cerebrospinal fluid and plasma. It will involve three cohorts: patients with prodromal NPH, symptomatic NPH patients, and healthy controls, followed over five years across seven European centers. Participants will undergo MRI scans, lumbar punctures for CSF and blood samples, and regular assessments to monitor changes in symptoms and biomarkers. The study will also evaluate the effects of shunt surgery on these variables.

Why it matters

Who can join: the full rules

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

Where it's running

• Bellaria Hospital
  Bologna, Italy Recruiting
• Uppsala University Hospital
  Uppsala, Sweden Recruiting
• Kuopio University Hospital
  Kuopio, Finland Not yet recruiting
• Sahlgrenska University Hospital
  Gothenburg, Sweden Not yet recruiting
• Linköping University Hospital
  Linköping, Sweden Not yet recruiting
• Karolinska University Hospital
  Stockholm, Sweden Not yet recruiting

Study contacts

• Principal investigator: Johan Virhammar, MD, PhD — Uppsala University Hospital
• Study coordinator: Johan Virhammar, MD, PhD
• Email: johan.virhammar@neuro.uu.se
• Phone: +46186110000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.