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

NCT05204745 | Completed

• 1 other identifier: 2017/335-31
• Study Type: observational
• Target: 6,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Idiopathic Normal Pressure Hydrocephalus

Outcome Measures

Primary Outcomes (1)

• Number of participants with Idiopathic Normal Pressure Hydrocephalus

  Diagnosis of INPH based on clinical evaluation and MRI.

  Through study completion, an average of approximately 1 month.

Study Arms (2)

Case

Subjects with subjective gait impariment according to questionnaire answers.

Control

Subjects without subjective gait impariment according to questionnaire answers.

Eligibility Criteria

• Age: 65 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• \- Living in Umeå, Sweden.

You may not qualify if:

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

Sponsors & Collaborators

• Umeå University: lead
• Region Västerbotten: collaborator

Study Sites (1)

Norrlands Universitetssjukhus

Umeå, Västerbotten County, 90737, Sweden

Location

MeSH Terms

Conditions

Brain Diseases; Central Nervous System Diseases; Dementia; Gait Disorders, Neurologic; Hydrocephalus, Normal Pressure

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hydrocephalus

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: January 24, 2022
• Study Start: February 14, 2018
• Primary Completion: December 22, 2021
• Study Completion: December 22, 2021
• Last Updated: January 24, 2022

Record last verified: 2022-01

Locations

SE (1)