Observational Study to Investigate the Effect of White Matter Tract Distortion and Neurodegenerative Biomarkers on Shunt-responsiveness in Idiopathic Normal Pressure Hydrocephalus (iNPH)

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Diagnostic test
Study Type: Observational
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: t
View:

• Adult patients \>60

• 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

Locations
Other Locations
United Kingdom
Imperial College Healthcare NHS Trust
RECRUITING
London
Contact Information
Primary
Chris Carswell
NPH@imperial.ac.uk
+44 20311 1234
Backup
Harvey G Burns
NPH@imperial.ac.uk
+44 20311 1234
Time Frame
Start Date: 2025-03-25
Estimated Completion Date: 2028-02
Participants
Target number of participants: 100
Treatments
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.
Group 2
Group 2 will include 30 adult patients with asymptomatic chronic hydrocephalus, non-hydrocephalus dementia and healthy controls.
Sponsors
Collaborators: Medical Research Council, Michael J. Fox Foundation for Parkinson's Research, University College, London, King's College London, University of Edinburgh
Leads: Imperial College London

This content was sourced from clinicaltrials.gov