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CompletedNCT05204745VESPRUpdated Jan 24, 2022

Ventriculomegaly and Gait Disturbance in the Senior Population in the Region of Västerbotten

An observational study in Idiopathic Normal Pressure Hydrocephalus (INPH), Brain Diseases and Central Nervous System Diseases, sponsored by Umeå University. Completed at 1 site in Sweden. Open to participants aged 65 Years to 84 Years. Per ClinicalTrials.gov, last updated 2022-01-24.

Sponsored by Umeå University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
6,500
Ages
65 Years to 84 Years
Sex
All
01

Study summary

Idiopathic normal pressure hydrocephalus (INPH) is a treatable disease of the elderly, typically causing gait impariment, dementia and urinary incontinence. The objective of this study is to make an epidemiological survey of INPH in Umeå, Sweden. Subjects with self-perceived gait impairments will be identified through a questionnaire. They will go through clinical examinations and have an MRI of the brain. A control population will also be investigated to enable comparisons between the populations. The main hypothesis is that the prevalence of INPH in the population is higher than what is previoulsy known.

02

Conditions studied

  • Idiopathic Normal Pressure Hydrocephalus (INPH)
  • Brain Diseases
  • Central Nervous System Diseases
  • Dementia
  • Gait Disorders, Neurologic
  • Hydrocephalus, Normal Pressure

Keywords

  • Idiopathic Normal Pressure Hydrocephalus
03

In context

Brain Diseases

763 studies on the registry are indexed under Brain Diseases; 203 are open to participants now.

This study's enrollment of 6,500 is above the median of 100 across 268 observational studies indexed under Brain Diseases.

Browse Brain Diseases studies →

Lead sponsor

Umeå University is the lead sponsor of 271 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The number of people, aged 65-84 years and living in Umeå, is approximately 18 000. Of these, 6500 will be randomly selected from the Swedish population registry. They will be asked to answer a mailed-out questionnaire regarding self-perceived gait impairment. Those with self-percieved gait impairment will be invited for clinical examinations as cases and a random selection of those without self-percieved gait impairment will be invited to participate in clinical examinations as controls.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

- Living in Umeå, Sweden.

Exclusion criteria

Exclusion Criteria:

  • Age \<65 or >84 years when the questionnaire was sent out.
  • Death at the time for the clinical evaluation.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
6,500 participants (actual)
Patient registry
No

Groups and cohorts

  • Case

    Subjects with subjective gait impariment according to questionnaire answers.

  • Control

    Subjects without subjective gait impariment according to questionnaire answers.

06

What researchers measure

Primary outcomes

  1. Number of participants with Idiopathic Normal Pressure Hydrocephalus

    Diagnosis of INPH based on clinical evaluation and MRI.

    Time frame: Through study completion, an average of approximately 1 month.

07

Study locations

1 site
  • Norrlands Universitetssjukhus
    Umeå, Västerbotten County 90737, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05204745
Lead sponsor
Umeå University
Collaborators
Region Västerbotten
Responsible party
Jan Malm (MD, PhD, Umeå University) — Principal investigator
First posted
Jan 24, 2022
Start date
Feb 14, 2018
Primary completion
Dec 22, 2021
Completion
Dec 22, 2021
Last update
Jan 24, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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