NCT06083233Completed
Role of Brain Specific Biomarkers in Hydrocephalus
Source: ClinicalTrials.gov · Last updated 21 Feb 2025
Brief summary (registry, in English)
Normal pressure hydrocephalus (NPH) is a neurodegenerative disease of unclear etiology characterized by a clinical trias named after the neurosurgeon Hakim. It includes cognitive impairment (dementia), gait disturbance, and urinary incontinence. These symptoms, which frequently occur in the elderly population, often overlap with the symptoms of "other" neurodegenerative diseases, especially Alzheimer's disease and other (pre)senile dementias. To distinguishing NPH from "other" dementias is crucial in determining whether a patient will benefit from a surgical procedure (ventriculoperitoneal shunt placement) or not. At the same time, the options for assessing the patient's condition's progression and distinguishing between the progression of neurodegeneration in a broader sense or malfunction of the drainage system are very limited. Therefore, the role of a biomarker that could meet these expectations mentioned above is highly desirable.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 32 (actual)
- First submitted
- 8 Oct 2023
- Start date
- 1 Nov 2023
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- University Hospital Hradec Kralove
- NCT number
- NCT06083233
What you commit to
- Study type: Observational
- Participants enrolled: 32
- From 1 Nov 2023 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Surgery lasting more than 120 minutes
Other illness
- Pre-existing other type of dementia (m. Alzheimer, vascular dementia)
Other
- Non-communicating hydrocephalus
- Structural lesion on MRI or CT (tumour, contusion, aneurysm)
- mini-mental state examination test \< 10 points
- Life-expectancy shorter than 1 year
- Blood loss more than 500 ml
- Adverse events during general anesthesia: mean arterial pressure \< 60 mm Hg more than 5 minutes, arrythmia with need for pharmacological treatment
Who the study is looking for
- Patients with diagnosed communicating hydrocephalus
- mini-mental state examination test \> 10 points
- Absence of any structural lesion on MRI or CT
- Accepted Informed consent
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Hradec Kralove Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.