Idiopathic Normal Pressure Hydrocephalus (INPH)VESPR2NCT07137403
Unsteady Gait in Older People May be a Common and Treatable Neurological Disease Associated With Increased Mortality
An observational study of Idiopathic Normal Pressure Hydrocephalus (INPH) and Gait Disorders, Neurologic, run by Umeå University at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Normal Pressure Hydrocephalus (INPH), Gait Disorders, Neurologic, Gait Disorders in Old Age
- How many people
- 450 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2025to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: 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.
Who may be able to join
- Participation in the study "Ventriculomegaly and gait disturbance in the senior population in the Region of Västerbotten" (VeSPR)
Who cannot join
- Bedridden
- Inability to leave informed consent due to cognitive decline
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read more
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?
- Conditions
- Idiopathic Normal Pressure Hydrocephalus (INPH), Gait Disorders, Neurologic, Gait Disorders in Old Age
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Higher-level gait disorder | Individuals who in our previous study had a higher-level gait disorder | |
| Other gait disorder/No gait disorder | Individuals who did not have a higher-level gait disorder during their visit in our pervious study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 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.
Measured: 6 years
Secondary outcomes (1)
MRI Biomarkers for prediction of HLGD
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.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Sep 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Normal Pressure Hydrocephalus (INPH)Studies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Västerbotten, The Swedish Brain Foundation (Hjärnfonden)
- Responsible party
- Principal investigator, Jenny Ma Larsson, Umeå University
- Investigators
- Jenny Larsson, MD, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137403
- Sponsor's protocol ID
- 2025-02534-01
- Other IDs
- 2025
- Acronym
- VESPR2
- Status last verified
- Apr 2026
- First submitted
- 14 Aug 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07137403
- Acronym / sponsor ID
- VESPR2 / 2025-02534-01
- Conditions
- Idiopathic Normal Pressure Hydrocephalus (INPH), Gait Disorders, Neurologic, Gait Disorders in Old Age
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Region Västerbotten, The Swedish Brain Foundation (Hjärnfonden)
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Higher-level gait disorder | – | –Individuals who in our previous study had a higher-level gait disorder |
| Other gait disorder/No gait disorder | – | –Individuals who did not have a higher-level gait disorder during their visit in our pervious study |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- Participation in the study "Ventriculomegaly and gait disturbance in the senior population in the Region of Västerbotten" (VeSPR)
Key exclusion criteria (2 listed)
- Bedridden
- Inability to leave informed consent due to cognitive decline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 6 years
6 year incidence of Higher-Level Gait Disorder and Idiopathic Normal Pressure Hydrocephalus
Time frame: 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.
1 secondary outcome
MRI Biomarkers for prediction of HLGD
Time frame: 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jenny Larsson, MD, PhD principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Normal Pressure Hydrocephalus (INPH) and Gait Disorders, Neurologic, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.