Unsteady Gait in Older People May be a Common and Treatable Neurological Disease Associated With Increased Mortality

NCT07137403 — Enrolling by invitation, 450 participants, Umeå University

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Unsteady Gait in Older People May be a Common and Treatable Neurological Disease Associated With Increased Mortality - Damage to the Glymphatic System May be the Cause

RegistryNCT07137403, acronym VESPR2
StatusEnrolling by invitation
Study typeObservational
Enrollment450 (Estimated)
SponsorUmeå University (Other); collaborators: Region Västerbotten, The Swedish Brain Foundation (Hjärnfonden)
ConditionsIdiopathic Normal Pressure Hydrocephalus (INPH), Gait Disorders, Neurologic, Gait Disorders in Old Age
Datesstart 2025-09-01, primary completion 2028-12-01 (estimated), completion 2029-12-01 (estimated), first posted 2025-08-22, last updated 2026-04-29
Locations1 site in Sweden

Related Papers Related Patents Related Grants Related Experts
All trials for Idiopathic Normal Pressure Hydrocephalus (INPH) All trials for Gait Disorders, Neurologic

-Summary

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?

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+Arms and interventions

ArmTypeInterventionsDescription
Higher-level gait disorderIndividuals who in our previous study had a higher-level gait disorder
Other gait disorder/No gait disorderIndividuals who did not have a higher-level gait disorder during their visit in our pervious study

+Outcome measures

Primary outcomes

  • Mortality [6 years]
  • 6 year incidence of Higher-Level Gait Disorder and Idiopathic Normal Pressure Hydrocephalus [6 years]: 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.

Secondary outcomes

  • MRI Biomarkers for prediction of HLGD [6 years]: MRI biomarkers commonly used in hydrocephalus diagnostics such as Evans Index, Callosal Angle and DESH will be evaluated for prediction of HLGD development. New biomarkers will also be investigated as potential new diagnostic tools.

+Eligibility

Sex: All, ages: 65 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Participation in the study "Ventriculomegaly and gait disturbance in the senior population in the Region of Västerbotten" (VeSPR)

Exclusion Criteria:

* Bedridden
* Inability to leave informed consent due to cognitive decline

+Locations (1)

FacilityCityCountryStatus
Umeå University HospitalUmeåSweden

+Investigators

+Funding

NIH grants: 2025