VESPR2
Sponsor study identifier
Secondary identifiers
NIH
observational
450
1 country
1
Study Start
September 1, 2025
Actual (reported)Primary Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
We live in an aging population and a third of the older population has a gait disorder that may cause institutionalization, and increased mortality. Sixteen percent of them have a slow, unsteady, neurological gait disorder, called Higher-Level Gait Disorder (HLGD). A known cause of HLGD is Idiopathic Normal Pressure Hydrocephalus (INPH), which is a treatable neurological disease. More than half of individuals with HLGD meet the diagnostic criteria for INPH as they have wide brain ventricles on MRI images of the brain, but far from all of these are in contact with the healthcare system. Possibly, HLGD without wide brain ventricles and where no other known explanation for the symptom is found could be a variant of or a precursor to INPH. Gait disorder is common among older people and can lead to falls and reduced quality of life. Complications after falls contribute to both increased mortality and increased costs in society. Therefore, it is important to have a solid knowledge of different types of gait disorders and how they can be treated. Our research will contribute with information about how HLGD affects the individual and how affected individuals can be investigated and helped. The disease mechanisms behind INPH and often behind HLGD are unknown. It is also unknown how often older individuals are affected by HLGD and how high the mortality is for those affected. It is likely that the incidence of HLGD is high and that it is linked to an increased mortality. It is also likely that the disease mechanism behind the symptom is the same as that of INPH and that HLGD can be detected with the help of brain imaging. In this epidemiological cohort study, we want to answer the following overarching questions: What is the incidence and mortality of HLGD and INPH? Can HLGD be predicted using biomarkers and what disease mechanism causes HLGD?
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 14, 2025
Actual (reported)August 22, 2025
Actual (reported)September 1, 2025
Actual (reported)December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Mortality
6 years
6 year incidence of Higher-Level Gait Disorder and Idiopathic Normal Pressure Hydrocephalus
Number of individuals that have developed a Higher-Level Gait Disorder and Idiopathic Normal Pressure Hydrocephalus since their last visit to us, in our previous study VESPR.
6 years
MRI Biomarkers for prediction of HLGD
6 years
Individuals who in our previous study had a higher-level gait disorder
Individuals who did not have a higher-level gait disorder during their visit in our pervious study
In the VeSPR study, a questionnaire about gait problems was sent to 6467 randomly selected individuals aged 65-84 years in Umeå. All with self-perceived gait problems (n=1510) and 513 controls without self-perceived gait problems were invited to a physical examination by a physician as well as clinical examinations of gait and balance, cognition and comorbidity. Of these, 1047 participated in clinical examinations (798 with gait disorders and 249 controls), 909 of them had a subsequent MRI of the brain and 98 had a computed tomography (CT) scan. With a theoretical constant mortality rate of 2.3%/year (Swedish official statistics on mortality in the age-group), there is a remaining population of 910 individuals from the previous study to invite to the 6-year follow-up. We expect about half of these will choose to participate, resulting in approximately 450 participants.
Umeå University Hospital
Umeå, Sweden
Blood samples
Jenny Larsson, MD, PhD
Umeå University
First Submitted
August 14, 2025
First Posted
August 22, 2025
Study Start
September 1, 2025
Actual (reported)Primary Completion
December 2028
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 29, 2026
Record last verified: 2026-04
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Source: ClinicalTrials.gov.
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