Normal Pressure HydrocephalusOWN-NPHNCT07103681
White Matter Distortion and Dementia Biomarkers in Normal Pressure Hydrocephalus (NPH)
An observational study of Normal Pressure Hydrocephalus, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Idiopathic Normal Pressure Hydrocephalus (iNPH) is a progressive condition of the elderly that results in severe disability. iNPH can dramatically respond to Cerebral spinal fluid(CSF)-shunting where excess ventricular fluid is diverted from the brain. Not all patients with iNPH respond to CSF-shunting however. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normal Pressure Hydrocephalus
- What is being tested?
- Ventriculoperitoneal Shunt (VP), Brain and Skin Biopsy and MRI Brain
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Mar 2025to Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with hydrocephalus, neurodegenerative disease and healthy controls will be recruited by Dr Chris Carswell at Imperial College Hospital NHS Trust.
Who may be able to join
- Adult patients >60
- With gait apraxia
- With or without cognitive impairment
- Urinary dysfunction
- Communicating Hydrocephalus
- Healthy Carers
Show all 10Show fewer
- Members of the Public
- Staff of Imperial College/ICHT
- Non-NPH Dementias (including Alzheimer's disease or vascular dementia)
- Asymptomatic Hydrocephalus
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Healthcare NHS Trust
London, W6 8RF
Chris Carswell, PHD, FRCP, +44 20311 1234, NPH@imperial.ac.uk
Harvey G Burns, +44 20311 1234, NPH@imperial.ac.uk
About this study
Official title: Observational Study to Investigate the Effect of White Matter Tract Distortion and Neurodegenerative Biomarkers on Shunt-responsiveness in Idiopathic Normal Pressure Hydrocephalus (iNPH)
Idiopathic Normal Pressure Hydrocephalus (iNPH) is a progressive condition of the elderly that results in severe disability. iNPH can dramatically respond to Cerebral spinal fluid(CSF)-shunting where excess ventricular fluid is diverted from the brain. Not all patients with iNPH respond to CSF-shunting however. The reasons for this are uncertain.
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.
Read more
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.
Read the detailed description
This single-centre observational cohort study will follow 50 patients diagnosed with symptomatic Normal Pressure Hydrocephalus (NPH) (idiopathic or late presenting congenital hydrocephalus and not secondary hydrocephalus) through their clinical journey, from initial assessment to post-CSF shunt surgery or a time when surgery is decided against. Separate groups of 50 asymptomatic individuals with chronic hydrocephalus and non-hydrocephalus individuals will act as controls.
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
- Normal Pressure Hydrocephalus
- Being tested
- Ventriculoperitoneal Shunt (VP), Brain and Skin Biopsy, MRI Brain
- Keywords
- hydrocephalus, activity monitors, gait impairment, shunt surgery, protokinetic, normal pressure hydrocephalus, shunt-responsiveness, white matter tractography, diffusion tensor imaging, neurodegenerative, NPH
- Medical subject headings
- Hydrocephalus, Normal Pressure, Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventriculoperitoneal Shunt (VP)Procedure or surgery
Also called VP Shunt
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 BiopsyProcedure or surgery
Brain and skin biopsy's may be taken during the VP shunt to assist in histological analysis for neurodegenerative changes.
MRI BrainDiagnostic test
MRI brain with diffusion imagining will be performed before and after shunt surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Ventriculoperitoneal Shunt (VP); Procedure: Brain and Skin Biopsy; Diagnostic Test: MRI Brain | |
| Group 2 | Group 2 will include 30 adult patients with asymptomatic chronic hydrocephalus, non-hydrocephalus dementia and healthy controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
White Matter Pathway Diffusion Metrics
Change from baseline in diffusion tensor imaging (DTI) metrics of white matter pathways (e.g. FA, AD, RD) before and after shunt surgery. The following tracts will be studied: corpus collosum, internal capsule, corona radiata and anterior thalamic radiation.
Measured: Perioperative
Secondary outcomes (20)
Neurodegenerative Biomarkers and CSF-shunt responsiveness
Composite degenerative index (plasma abeta, GFAP, Ptau217, NfL, CSF synuclein RT QuIC and brain and skin histology) will be generated and compared between CSF shunt-responsive and CSF non-responsive groups.
Measured: Perioperative
Serum Neurodegenerative Biomarkers
The serum biomarkers will measure a-beta (pg/ml), G-FAB (pg/ml), NfL (pg/ml) and p-tau217 (pg/ml).
Measured: From enrolment, at periprocedural and up to 27 weeks
Sleep Monitoring
The Withings' Sleep mats are devices designed to track sleep patterns. Participants will be offered under mattress sleep monitors capable of showing time spent in bed and analyse sleep cycles.
Measured: From enrolment and through study completion, an average of 1 year
Activity Monitoring
The Withings' Activity Monitors are devices designed to track physical activity and heart rate. Participants will be offered wrist activity monitors which capture data on steps taken, calories burned and overall movement throughout the day, providing insights into daily activity levels.
Measured: From enrolment and through study completion, an average of 1 year
Tinetti Performance Oriented Mobility Assessment Score (balance)
Total scores range from 0 to 16, with higher scores indicating better outcomes of balance performance.
Measured: From enrolment, at periprocedural and up to 27 weeks
Tinetti Performance Oriented Mobility Assessment Score (Gait)
Total scores range from 0 to 12, with higher scores indicating better outcomes of gait performance.
Measured: From enrolment, at periprocedural and up to 27 weeks
International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form (ICIQ UI SF)
The assessment measures the frequency and severity of urinary incontinence. The total scores range from 0-21. Higher scores indicate worse bladder symptoms.
Measured: From enrolment, at periprocedural and up to 27 weeks.
International Consultation on Incontinence Questionnaire for Bowels (ICIQ-B)
The assessment measures the pattern and control of bowel incontinence. The total scores for bowel pattern ranges from 1-21 and bowel control ranges from 0-28. Higher scores indicate worse bowel symptoms.
Measured: From enrolment, at periprocedural and up to 27 weeks.
International Consultation of Incontinence Questionnaire for Sexual Function
The assessment measures the severity and bother of sexual function. The scores for sexual function range from 1-5 and are assessed on an individual basis. Higher scores indicate worse sexual function.
Measured: From enrolment, at periprocedural and up to 27 weeks.
International Consultation of Incontinence Questionnaire for Quality of Life
The assessment measures the quality of life bladder, bowels and sexual function has on the individual. The scores suggest how much they bother the participant and it ranges from 0-10. Higher bother scores indicate lower quality of life.
Measured: From enrolment, at periprocedural and up to 27 weeks.
Overactive Bladder Symptoms (OAB)
The total score ranges from 0 to 15, with higher scores indicating worse bladder severity symptoms.
Measured: From enrolment, at periprocedural, and up to 27 weeks.
Kubo scale
Assesses gait disturbance, cognitive impairment and urinary disturbance. Total scores range from 0 to 12, with higher scores indicating better outcomes.
Measured: From enrolment, at periprocedural and up to 27 weeks.
Patient Health Questionnaire-9 (PHQ-9)
Assesses the severity of depression. Total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms.
Measured: From enrolment, at periprocedural and up to 27 weeks.
Generalised Anxiety Disorder-7 (GAD-7)
Assesses the severity of anxiety symptoms. Total scores range from 0 to 21, with higher scores indicating more severe anxiety.
Measured: From enrolment, at periprocedural and up to 27 weeks.
Sintonen 15D
Overall score adds 15 metrics of quality of life. Total scores range from 75-15 with lower scores indicating better quality of life.
Measured: From enrolment, at periprocedural and up to 27 weeks.
PSP QoL
Overall score adds 45 metrics of quality of life using a Likert scale to score from 0-5. Total scores range from 0-225 with lower scores indicating better quality of life.
Measured: From enrolment, at periprocedural and up to 27 weeks.
Rockwood Clinical Frailty Scale Score
Frailty rating score in older adults. Total scores range from 1 to 9 with higher indicating greater frailty.
Measured: From enrolment, at periprocedural and up to 27 weeks.
Addenbrooke's Cognitive Examination ||| (ACE-|||)
Total score evaluates cognitive functions including memory, language, visuospatial, attention and language. Total scores range from 0 to 100, with higher scores indicating better cognitive function.
Measured: From enrolment, at periprocedural and up to 27 weeks.
Cognitron Cognitive Assessment Platform
Includes a total score of a collection of cognitive tests to assess various cognitive domains in those with NPH pre and post surgery. There are specific domain specific scores.
Measured: From enrolment, at periprocedural and up to 27 weeks.
PKMAS Gait Analysis Software
Objective gait metric data is taken from the Protokinetics gait mat to analyse gait parameters of those with NPH. These metrics include, all aspects of gait (e.g. foot length, gait velocity, stride length)
Measured: From enrolment, at periprocedural and up to 27 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start25 Mar 2025
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Pressure HydrocephalusStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, Michael J. Fox Foundation for Parkinson's Research, University College, London, University of Edinburgh, King's College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103681
- Sponsor's protocol ID
- 311620
- Other IDs
- W0300981
- Acronym
- OWN-NPH
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may be shared with collaborators if it is within the remit of the ethics approval and depending on the nature of the collaboration.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Investigate the Effect of White Matter Tract Distortion and Neurodegenerative Biomarkers on Shunt-responsiveness in Idiopathic Normal Pressure Hydrocephalus (iNPH)
- ClinicalTrials.gov ID
- NCT07103681
- Acronym / sponsor ID
- OWN-NPH / 311620
- Conditions
- Normal Pressure Hydrocephalus
- Keywords
- hydrocephalus, activity monitors, gait impairment, shunt surgery, protokinetic, normal pressure hydrocephalus, shunt-responsiveness, white matter tractography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Medical Research Council, Michael J. Fox Foundation for Parkinson's Research, University College, London, University of Edinburgh, King's College London
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Idiopathic Normal Pressure Hydrocephalus (iNPH) is a progressive condition of the elderly that results in severe disability. iNPH can dramatically respond to Cerebral spinal fluid(CSF)-shunting where excess ventricular fluid is diverted from the brain. Not all patients with iNPH respond to CSF-shunting however. The reasons for this are uncertain.
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.
Detailed description
This single-centre observational cohort study will follow 50 patients diagnosed with symptomatic Normal Pressure Hydrocephalus (NPH) (idiopathic or late presenting congenital hydrocephalus and not secondary hydrocephalus) through their clinical journey, from initial assessment to post-CSF shunt surgery or a time when surgery is decided against. Separate groups of 50 asymptomatic individuals with chronic hydrocephalus and non-hydrocephalus individuals will act as controls.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Ventriculoperitoneal Shunt (VP), Procedure: Brain and Skin Biopsy, Diagnostic Test: MRI BrainGroup 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. |
| Group 2 | – | –Group 2 will include 30 adult patients with asymptomatic chronic hydrocephalus, non-hydrocephalus dementia and healthy controls. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hydrocephalus, neurodegenerative disease and healthy controls will be recruited by Dr Chris Carswell at Imperial College Hospital NHS Trust.
Key inclusion criteria (10 listed)
- Adult patients >60
- With gait apraxia
- With or without cognitive impairment
- Urinary dysfunction
- Communicating Hydrocephalus
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventriculoperitoneal Shunt (VP)Also: VP ShuntVP 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. | Procedure or surgery | Group 1 |
| Brain and Skin BiopsyBrain and skin biopsy's may be taken during the VP shunt to assist in histological analysis for neurodegenerative changes. | Procedure or surgery | Group 1 |
| MRI BrainMRI brain with diffusion imagining will be performed before and after shunt surgery. | Diagnostic test | Group 1 |
Primary outcome
White Matter Pathway Diffusion Metrics
Time frame: Perioperative
Change from baseline in diffusion tensor imaging (DTI) metrics of white matter pathways (e.g. FA, AD, RD) before and after shunt surgery. The following tracts will be studied: corpus collosum, internal capsule, corona radiata and anterior thalamic radiation.
20 secondary outcomes
Neurodegenerative Biomarkers and CSF-shunt responsiveness
Time frame: Perioperative
Serum Neurodegenerative Biomarkers
Time frame: From enrolment, at periprocedural and up to 27 weeks
Sleep Monitoring
Time frame: From enrolment and through study completion, an average of 1 year
Activity Monitoring
Time frame: From enrolment and through study completion, an average of 1 year
Tinetti Performance Oriented Mobility Assessment Score (balance)
Time frame: From enrolment, at periprocedural and up to 27 weeks
Tinetti Performance Oriented Mobility Assessment Score (Gait)
Time frame: From enrolment, at periprocedural and up to 27 weeks
International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form (ICIQ UI SF)
Time frame: From enrolment, at periprocedural and up to 27 weeks.
International Consultation on Incontinence Questionnaire for Bowels (ICIQ-B)
Time frame: From enrolment, at periprocedural and up to 27 weeks.
International Consultation of Incontinence Questionnaire for Sexual Function
Time frame: From enrolment, at periprocedural and up to 27 weeks.
International Consultation of Incontinence Questionnaire for Quality of Life
Time frame: From enrolment, at periprocedural and up to 27 weeks.
Overactive Bladder Symptoms (OAB)
Time frame: From enrolment, at periprocedural, and up to 27 weeks.
Kubo scale
Time frame: From enrolment, at periprocedural and up to 27 weeks.
Patient Health Questionnaire-9 (PHQ-9)
Time frame: From enrolment, at periprocedural and up to 27 weeks.
Generalised Anxiety Disorder-7 (GAD-7)
Time frame: From enrolment, at periprocedural and up to 27 weeks.
Sintonen 15D
Time frame: From enrolment, at periprocedural and up to 27 weeks.
PSP QoL
Time frame: From enrolment, at periprocedural and up to 27 weeks.
Rockwood Clinical Frailty Scale Score
Time frame: From enrolment, at periprocedural and up to 27 weeks.
Addenbrooke's Cognitive Examination ||| (ACE-|||)
Time frame: From enrolment, at periprocedural and up to 27 weeks.
Cognitron Cognitive Assessment Platform
Time frame: From enrolment, at periprocedural and up to 27 weeks.
PKMAS Gait Analysis Software
Time frame: From enrolment, at periprocedural and up to 27 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Undecided. IPD may be shared with collaborators if it is within the remit of the ethics approval and depending on the nature of the collaboration.
Related trials for Normal Pressure Hydrocephalus
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Pressure Hydrocephalus, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chris Carswell (+44 20311 1234, NPH@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
White Matter Pathway Diffusion Metrics (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.