European Study of Prodromal iNPH

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

• 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

• iNPH diagnosis according to international guidelines.19

• Age matched with the individual in Group 1 (+/- 3 years)

Locations
Other Locations
Finland
Kuopio University Hospital
NOT_YET_RECRUITING
Kuopio
Italy
Bellaria Hospital
RECRUITING
Bologna
Sweden
Sahlgrenska University Hospital
NOT_YET_RECRUITING
Gothenburg
Linköping University Hospital
NOT_YET_RECRUITING
Linköping
Karolinska University Hospital
NOT_YET_RECRUITING
Stockholm
Umeå University Hospital
NOT_YET_RECRUITING
Umeå
Uppsala University Hospital
RECRUITING
Uppsala
Contact Information
Primary
Johan Virhammar, MD, PhD
johan.virhammar@neuro.uu.se
+46186110000
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2035-12-31
Participants
Target number of participants: 140
Treatments
Group 1 - prodromal iNPH
Individuals with typical imaging findings consistent with iNPH but none or too mild symptoms to motivate shunt surgery.
Group 2 - Healthy controls
Age matched healthy controls
Group 3 - symptomatic iNPH
Patients with symptomatic iNPH
Sponsors
Leads: Johan Virhammar
Collaborators: Swedish Society for Medical Research

This content was sourced from clinicaltrials.gov