Actively Recruiting
Observational Study to Investigate White Matter Tract Changes and Dementia Biomarkers Affecting Shunt Response in Idiopathic Normal Pressure Hydrocephalus
Led by Imperial College London · Updated on 2026-03-27
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
I
Imperial College London
Lead Sponsor
M
Medical Research Council
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating Idiopathic Normal Pressure Hydrocephalus (iNPH), a progressive condition affecting older adults that can cause severe disability. This observational study aims to understand differences in nerve pathways near brain ventricles between patients who respond to cerebrospinal fluid (CSF) shunting and those who do not. It also explores links between dementia-like illnesses and shunt responsiveness, the use of wearable activity and sleep monitors, and digital cognitive assessments before and after surgery. The study will follow 50 patients diagnosed with symptomatic iNPH from initial assessment through post-CSF shunt surgery or a decision not to operate. Two additional groups of 50 adults each, including asymptomatic chronic hydrocephalus patients and non-hydrocephalus individuals, will serve as controls. Participants will undergo clinical evaluations of gait, cognition, urinary function, and quality of life. Procedures include MRI scans with diffusion imaging, biomarker analysis of serum and CSF, and optional brain and skin biopsies during shunt surgery. Participants will be monitored over time for changes in clinical symptoms and imaging before and after shunting. Assessments include various mobility, urinary, cognitive, and quality of life questionnaires conducted from enrollment through up to 27 weeks post-procedure. Activity and sleep will be continuously monitored for about one year. The main outcome measures focus on imaging changes in white matter tracts around the time of surgery and relationships between biomarkers and clinical results. Data will be securely stored and analyzed to identify factors linked to shunt response.
CONDITIONS
Brief Title
White Matter Distortion and Dementia Biomarkers in Normal Pressure Hydrocephalus (NPH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients over 60 years old
- Diagnosed with communicating hydrocephalus
- Presenting with gait apraxia
- With or without cognitive impairment
- Experiencing urinary dysfunction
- Group 2 includes healthy carers, public members, Imperial College staff, non-NPH dementias, or asymptomatic hydrocephalus
You will not qualify if you...
- Asymptomatic hydrocephalus in Group 1
- High pressure hydrocephalus
- Serious head injury or brain infection within 5 years
- History of childhood gait disturbance
- Alternative explanations for symptoms (e.g., Parkinson's, neuropathy, myelopathy)
- Too frail for shunt surgery
- Medically unstable conditions (e.g., active angina, respiratory disease, epilepsy)
- Unable to tolerate MRI brain imaging
- Unable to have lumbar puncture
- Immobile
- Unable to attend hospital visits for study assessments (Group 2)
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks
Participants undergo clinical assessments including gait, cognitive and urinary evaluations, quality of life measures, serum and CSF biomarker analysis, and diffusion-weighted MRI brain scans to evaluate white matter tract changes and dementia biomarkers.
1 to 2 visits depending on assessments
Duration - Surgery day plus immediate recovery
Participants in Group 1 who are clinically indicated will undergo ventriculoperitoneal (VP) shunt surgery. Brain and skin biopsies may be performed during surgery to assist in histological analysis.
1 surgical visit (in-person)
Duration - Up to 27 weeks
Participants are monitored after surgery with follow-up clinical assessments, MRI brain scans, and biomarker analysis to evaluate shunt response and clinical outcomes over time.
Multiple visits including periprocedural and follow-up assessments up to 27 weeks
Duration - Approximately 1 year
Participants undergo ongoing sleep and activity monitoring, as well as repeated clinical evaluations for an average of 1 year to assess long-term outcomes and changes.
Regular monitoring visits and assessments during the study period
Trial Site Locations
Total: 1 location
1
Imperial College Healthcare NHS Trust
London, United Kingdom, W6 8RF
Actively Recruiting
Research Team
C
Chris Carswell
H
Harvey G Burns
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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