Idiopathic Normal Pressure Hydrocephalus (INPH)VESPRNCT05204745
Ventriculomegaly and Gait Disturbance in the Senior Population in the Region of Västerbotten
An observational study of Idiopathic Normal Pressure Hydrocephalus (INPH) and Brain Diseases, run by Umeå University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 84 years
- Conditions the study is for
- Idiopathic Normal Pressure Hydrocephalus (INPH), Brain Diseases, Central Nervous System Diseases
- How many people
- 6,500 participants
- Where
- 1 siteSweden
- Study dates
- 14 Feb 2018to 22 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 84 years
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- Living in Umeå, Sweden.
Who cannot join
- Age <65 or >84 years when the questionnaire was sent out.
- Death at the time for the clinical evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gait and Balance Impairment, Dementia and Wide Brain Ventricles in the Ages 65-84 Years
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.
- Conditions
- Idiopathic Normal Pressure Hydrocephalus (INPH), Brain Diseases, Central Nervous System Diseases, Dementia, Gait Disorders, Neurologic, Hydrocephalus, Normal Pressure
- Keywords
- Idiopathic Normal Pressure Hydrocephalus
- Medical subject headings
- Brain Diseases, Central Nervous System Diseases, Dementia, Gait Disorders, Neurologic, Hydrocephalus, Normal Pressure
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 |
|---|---|---|
| Case | Subjects with subjective gait impariment according to questionnaire answers. | |
| Control | Subjects without subjective gait impariment according to questionnaire answers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Idiopathic Normal Pressure Hydrocephalus
Diagnosis of INPH based on clinical evaluation and MRI.
Measured: Through study completion, an average of approximately 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start14 Feb 2018
- Primary completion22 Dec 2021
- Study completion22 Dec 2021
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 6,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Västerbotten
- Responsible party
- Principal investigator, Jan Malm, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204745
- Sponsor's protocol ID
- 2017/335-31
- Acronym
- VESPR
- Status last verified
- Jan 2022
- First submitted
- 1 Oct 2021
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait and Balance Impairment, Dementia and Wide Brain Ventricles in the Ages 65-84 Years
- ClinicalTrials.gov ID
- NCT05204745
- Acronym / sponsor ID
- VESPR / 2017/335-31
- Conditions
- Idiopathic Normal Pressure Hydrocephalus (INPH), Brain Diseases, Central Nervous System Diseases, Dementia, Gait Disorders, Neurologic, Hydrocephalus, Normal Pressure
- Keywords
- Idiopathic Normal Pressure Hydrocephalus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,500 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Region Västerbotten
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 24 Jan 2022 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | –Subjects with subjective gait impariment according to questionnaire answers. |
| Control | – | –Subjects without subjective gait impariment according to questionnaire answers. |
Who may qualify
- Ages
- 65 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (1 listed)
- Living in Umeå, Sweden.
Key exclusion criteria (2 listed)
- Age <65 or >84 years when the questionnaire was sent out.
- Death at the time for the clinical evaluation.
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
Number of participants with Idiopathic Normal Pressure Hydrocephalus
Time frame: Through study completion, an average of approximately 1 month.
Diagnosis of INPH based on clinical evaluation and MRI.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Brain Diseases, 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: finished, as of the sponsor's last update on 24 Jan 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with Idiopathic Normal Pressure Hydrocephalus (time frame: Through study completion, an average of approximately 1 month.). 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 24 Jan 2022.