White matter damage and dementia markers in normal pressure hydrocephalus
Observational Study to Investigate the Effect of White Matter Tract Distortion and Neurodegenerative Biomarkers on Shunt-responsiveness in Idiopathic Normal Pressure Hydrocephalus (iNPH)
This study tries to see if patterns of white matter damage, dementia-related biomarkers, wearable activity monitors, and digital cognitive tests can predict and track which older adults with normal pressure hydrocephalus will improve after CSF shunt surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT07103681 on ClinicalTrials.gov |
What this trial studies
This single-center observational cohort will follow about 50 symptomatic adults with idiopathic or late-presenting communicating normal pressure hydrocephalus through initial assessment and, if performed, CSF shunt surgery, with two control groups of 50 asymptomatic chronic-hydrocephalus and 50 non-hydrocephalus participants. Participants undergo detailed gait, cognitive, urinary, and quality-of-life testing alongside diffusion MRI, blood and CSF biomarker sampling, and optional brain and skin biopsies. The study will also test the acceptability and data value of wearable activity and bed-sleep monitors and self-administered digital cognitive assessments before and after surgery. Clinical, imaging, and biomarker data will be stored in REDCap and analyzed to compare changes in shunt responders versus non-responders, with shunt response defined by gait speed improvement.
Who should consider this trial
Good fit: Adults over 60 with symptomatic communicating normal pressure hydrocephalus (not secondary causes), particularly those with gait difficulty and who can tolerate MRI and lumbar puncture and are suitable candidates for possible shunt surgery.
Not a fit: People who are asymptomatic, have secondary or high‑pressure hydrocephalus, have a clear alternative explanation for symptoms (for example advanced Parkinson's disease), are too frail or medically unstable for surgery, or cannot undergo MRI or lumbar puncture are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this work could help doctors predict who is likely to benefit from CSF shunting and provide objective ways to monitor recovery using biomarkers and wearable/digital measures.
How similar studies have performed: Prior small studies have identified some imaging and CSF biomarker patterns linked to shunt response but results are mixed, and the use of wearables and self‑administered digital cognitive testing in NPH is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Group 1 (communicating hydrocephalus): Inclusion Criteria: * Adult patients \>60 * With gait apraxia * With or without cognitive impairment * Urinary dysfunction * Communicating Hydrocephalus Exclusion Criteria: * Asymptomatic hydrocephalus * High pressure-hydrocephalus * Serious head injury within 5 years of presentation or a clear secondary cause (e.g. brain infection) * History of childhood gait disturbance * Clear alternative explanation for symptoms (e.g. Parkinson's disease with limb rigidity, peripheral neuropathy with sensory ataxia, cervical myelopathy). * Too frail for shunt surgery * Medically unstable (e.g. active angina, respiratory disease, recurrent delirium, active epilepsy). * Unable to tolerate MRI brain imaging * Unable to have a lumbar puncture * Immobile * Unable to attend the hospital for study visits Group 2 (asymptomatic and non-hydrocepahlus dementia and healthy controls): Inclusion Criteria (Any of the following): * Healthy Carers * Members of the Public * Staff of Imperial College/ICHT * Non-NPH Dementias (including Alzheimer's disease or vascular dementia) * Asymptomatic Hydrocephalus Exclusion Criteria: \- Unable to attend the hospital for study visits
Where this trial is running
London
- Imperial College Healthcare NHS Trust — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Chris Carswell
- Email: NPH@imperial.ac.uk
- Phone: +44 20311 1234
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.