White Matter Distortion and Dementia Biomarkers in Normal Pressure Hydrocephalus (NPH)
NCT ID: NCT07103681
Last Updated: 2025-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2025-03-25
2028-02-29
Brief Summary
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Aim 1: To understand if specific nerve pathways (white matter tracts) that are near ventricles are damaged in patients that respond to shunting as opposed to those that do not.
Aim 2: Can we explain shunt non-responsiveness by screening for dementia like illnesses (neurodegeneration) using a large array of methods.
Aim 3: To understand whether wearable activity and bed sleep monitors are palatable in a NPH population and to understand if these metrics relate to quality of life.
Aim 4: To see whether self-administered digital cognitive assessments can measure improvements pre and post surgery.
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Detailed Description
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Participants will undergo comprehensive clinical assessments including gait, cognitive and urinary evaluations, quality of life measures, serum and CSF degenerative biomarker analysis, diffusion-weighted Magnetic Resonance Imaging (MRI) and optional brain and skin biopsies. Data collection will focus on capturing changes in clinical presentation and imaging findings before and after shunting. REDCap will be utilised as the primary tool for data storage.
Primary outcome measures assess pre and post-shunting imaging changes in shunt-responders and non-responders. Shunt response will be defined as 10% improvement in gait speed. Secondary outcomes evaluate the relationship between biomarkers and clinical outcomes. Longitudinal data will help identify factors distinguishing responders from non-responders, with descriptive and inferential statistics used.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
Group 1 includes adults over 60 years old diagnosed with late-onset communicating hydrocephalus, characterised by gait apraxia, with or without cognitive impairment and urinary dysfunction. Eligibility is confirmed through clinical imaging showing an Evan's index \>0.3 and an iNPH Radscale score \>4. Individuals with recent severe head trauma, high-pressure hydrocephalus, or alternative causes for similar symptoms are excluded. This criteria for group 1 ensures a distinct group for studying the late-onset, communicating form of the condition.
Ventriculoperitoneal Shunt (VP)
VP Shunt surgery involves surgical insertion of a catheter (tube) to divert brain fluid from the cerebral ventricles to the abdominal peritoneum. This will be performed in Group 1 patients as clinically indicated.
Brain and Skin Biopsy
Brain and skin biopsy's may be taken during the VP shunt to assist in histological analysis for neurodegenerative changes.
MRI Brain
MRI brain with diffusion imagining will be performed before and after shunt surgery.
Group 2
Group 2 will include 30 adult patients with asymptomatic chronic hydrocephalus, non-hydrocephalus dementia and healthy controls.
No interventions assigned to this group
Interventions
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Ventriculoperitoneal Shunt (VP)
VP Shunt surgery involves surgical insertion of a catheter (tube) to divert brain fluid from the cerebral ventricles to the abdominal peritoneum. This will be performed in Group 1 patients as clinically indicated.
Brain and Skin Biopsy
Brain and skin biopsy's may be taken during the VP shunt to assist in histological analysis for neurodegenerative changes.
MRI Brain
MRI brain with diffusion imagining will be performed before and after shunt surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* With gait apraxia
* With or without cognitive impairment
* Urinary dysfunction
* Communicating Hydrocephalus
* 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
* 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):
\- Unable to attend the hospital for study visits
60 Years
ALL
Yes
Sponsors
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Medical Research Council
OTHER_GOV
Michael J. Fox Foundation for Parkinson's Research
OTHER
University College, London
OTHER
University of Edinburgh
OTHER
King's College London
OTHER
Imperial College London
OTHER
Responsible Party
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Locations
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Imperial College Healthcare NHS Trust
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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W0300981
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
311620
Identifier Type: -
Identifier Source: org_study_id
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