Trial · NCT04975269
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportional change in gait function | Change from baseline gait function immediately after intervention (at time of shunt surgery) | Gait function is determined by one variable that is calculated as the mean time and number of steps of three different gait tests: 10 meter walking in self chosen speed, timed up and go test (TUG) and 3 m walking backwards. The two fastest attempts of three attempts for each test are documented. The mean time and number of steps of the two fastest attempts for the three tests are calculated to a single variable and the proportional difference between study visits is used as the primary outcome variable. |
| Secondary | Change in idiopathic normal pressure hydrocephalus (iNPH) scale | Change from baseline iNPH-scale score immediately after intervention (at time of shunt surgery) | Swedish idiopathic normal pressure hydrocephalus (iNPH) scale that is a combination of subscales for gait, balance, cognition and continence. Minimum value is 0 and maximum value is 100. High values indicate better function. |
| Secondary | Change in volume of periventricular hyperintensities | Change from baseline at 3 months | Measured using volumetric MRI |
| Secondary | Change in cerebral blood perfusion | Change from baseline at 3 months | Measured using pseudo continuous arterial spin labeling (MRI perfusion) |
| Secondary | Change in quantified CSF flow in cerebral aqueduct | Change from baseline at 3 months | Measured using phase contrast MRI |
| Secondary | Change in parenchymal water content | Change from baseline at 3 months | Measured using Synthetic MRI |
| Secondary | Change in cerebral myelin volume | Change from baseline at 3 months | Measured using Synthetic MRI |
| Secondary | Changes in plasma biomarkers | Change from baseline immediately after intervention (at time of shunt surgery) | Change in plasma levels of neurofilament light chain protein, Total-tau, amyloid beta-42, glial fibrillary acidic protein will be measured using Quanterix (SIMOA). |
| Secondary | Change in CSF biomarkers | Change from baseline immediately after intervention (at time of shunt surgery) | CSF levels of neurofilament light chain protein, Total-tau, amyloid beta-42, glial fibrillary acidic protein will be measured using Quanterix (SIMOA). |
| Secondary | Changes in plasma and CSF proteins | Change from baseline immediately after intervention (at time of shunt surgery) | Semi-quantified levels of approximately 200 proteins are measured with proximity extension assay (Neurology panel and Neuro exploratory panel, Olink.com). |
| Secondary | Patients self reported assessment of symptoms | Change from baseline immediately after intervention (at time of shunt surgery) | Gait, cognition, continence, balance, activities of daily life and quality of life is rated by patients on a questionnaire using 4-level scales. |
| Secondary | Change in Euro-Quality of Life-5 dimension-5L (EQ-5D-5L) descriptive system | Change from baseline EQ-5D-5L score immediately after intervention (at time of shunt surgery) | Measured using EQ-5D-5L using the descriptive system. |
| Secondary | Change in Euro-Quality of Life-5 dimension-5L (EQ-5D-5L) VAS | Change from baseline EQ-5D-5L score immediately after intervention (at time of shunt surgery) | Measured using the visual analogue scale (VAS) in EQ-5D-5L. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT04975269/registered