Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05910944
Status:
RECRUITING
Last Update Posted:
2023-11-30
First Post:
2023-05-10
Brief Title:
European Study of Prodromal iNPH
Sponsor:
Johan Virhammar
Organization:
Uppsala University Hospital
Study Overview
Official Title:
European Study of Prodromal iNPH
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STOP iNPH
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
Detailed Description:
Three prospective cohorts will be included during five years from seven European centers
Group 1 - Prodromal NPH Patients with imaging features associated with iNPH and no symptoms or to little symptoms to motivate shunt surgery will be included prospectively At baseline an MRI of the brain will be performed and a lumbar puncture to collect CSF as well as blood samples The patients will be followed with a standardized scheme that will go on for as long as the patient chose to remain in the study or until the patient develops symptoms and are referred for shunt surgery The study scheme includes repeated assessments of symptoms MRI of the brain CSF samples and blood samples The following study visits are planned before surgery baseline 6 months 1st year 2nd year 4th year 6th year After shunt surgery clinical evaluations and blood samples will be collected at four assessments during five years post-operative
Group 2 - Healthy controls - For every patient in Group 1 one patient can be included in Group 2 They will be investigated with the same protocol as Group 1 but only follow the protocol for one cycle Baseline to year 4
Group 3 - Symptomatic NPH - For each included individual in Group 1 prodromal NPH two patients are included in Group 3 symptomatic NPH These patients are consecutively included at each centre from routine patients that are planned for shunt surgery They should be age matched with the individual in Group 1 - 3 years Their investigations will be identical with the post-operative routine for five years as Group 1
Group 1 - Prodromal NPH Patients with imaging features associated with iNPH and no symptoms or to little symptoms to motivate shunt surgery will be included prospectively At baseline an MRI of the brain will be performed and a lumbar puncture to collect CSF as well as blood samples The patients will be followed with a standardized scheme that will go on for as long as the patient chose to remain in the study or until the patient develops symptoms and are referred for shunt surgery The study scheme includes repeated assessments of symptoms MRI of the brain CSF samples and blood samples The following study visits are planned before surgery baseline 6 months 1st year 2nd year 4th year 6th year After shunt surgery clinical evaluations and blood samples will be collected at four assessments during five years post-operative
Group 2 - Healthy controls - For every patient in Group 1 one patient can be included in Group 2 They will be investigated with the same protocol as Group 1 but only follow the protocol for one cycle Baseline to year 4
Group 3 - Symptomatic NPH - For each included individual in Group 1 prodromal NPH two patients are included in Group 3 symptomatic NPH These patients are consecutively included at each centre from routine patients that are planned for shunt surgery They should be age matched with the individual in Group 1 - 3 years Their investigations will be identical with the post-operative routine for five years as Group 1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None