Brief 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.

Conditions

• Normal Pressure Hydrocephalus
• Hydrocephalus

Intervention / Treatment

• Procedure: Shunt surgery

Primary Outcome Measures

• Frequency of patients with prodromal iNPH that requires shunt surgery within 6 years from inclusion. (From date of inclusion until decision of shunt surgery, assessed up to 72 months)
  Symptoms are assessed with the idiopathic Normal Pressure Hydrocephalus scale (iNPH-scale) with addition of the gait tests: 10 meter walking in maximum speed, timed up and go test (TUG) and 3 m walking backwards. Each center decides when symptoms have progressed enough to motivate shunt surgery according to local traditions and routine. Low values in time and steps of the gait tests indicate good performance and high values of the iNPH-scale (range: 0-100) indicates good performance.
• Frequency of patients with prodromal iNPH that progress to symptomatic iNPH (From date of inclusion until 20 points reduction in total iNPH-scale score or 20% reduction in gait speed, assessed up to 72 months)
  Symptoms are assessed with the iNPH-scale with addition of the gait tests: 10 meter walking in maximum speed, timed up and go test (TUG) and 3 m walking backwards. A patient is considered symptomatic when total iNPH-scale is reduced by at least 20 points or the mean speed of the gait tests are reduced by 20%. Low values in time and steps of the gait tests indicate good performance and high values of the iNPH-scale (range: 0-100) indicates good performance.
• Post operative improvement in iNPH-scale score in patients with mild, moderate and severe preoperative symptoms (Change from preoperative (last visit before surgery) iNPH scale at 3 months, 12 months, 36 months and 60 months follow-up.)
  Differences in short (3 and 12 months) and long-term outcome (36 and 60 months) measured as change between preoperative and postoperative iNPH-scale score will be compared between patients with mild, moderate and severe preoperative symptoms. High values of the iNPH-scale (range: 0-100) indicates good performance.

Countries

Finland, Italy, Sweden

Locations and Investigators

• Kuopio University Hospital, Kuopio, Finland (Not yet recruiting)
  • Ville Leinonen, MD, PhD
• Bellaria Hospital, Bologna, Italy (Recruiting)
  • Giorgio Palandri, MD, PhD
• Sahlgrenska University Hospital, Gothenburg, Sweden (Not yet recruiting)
  • Mats Tullberg, MD, PhD
• Linköping University Hospital, Linköping, Sweden (Not yet recruiting)
  • Fredrik Lundin, MD, PhD
  • Katarina Laurell, MD, PhD
• Karolinska University Hospital, Stockholm, Sweden (Not yet recruiting)
  • Lisa Arvidsson, MD, PhD
  • Jens Tomner, MD
• Umeå University Hospital, Umeå, Sweden (Not yet recruiting)
  • William Hansson, MD
  • Jan Malm, MD, PhD
• Uppsala University Hospital, Uppsala, Sweden (Recruiting)
  • Johan Virhammar, MD, PhD

Study Officials

• Johan Virhammar, MD, PhD (Principal Investigator) — Uppsala University Hospital