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Recruiting NCT07103681

White Matter Distortion and Dementia Biomarkers in Normal Pressure Hydrocephalus (NPH)

— Observational Normal Pressure Hydrocephalus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ventriculoperitoneal Shunt (VP), Brain and Skin Biopsy, MRI Brain.
Who it may be relevant to
Registry conditions: Normal Pressure Hydrocephalus. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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)

Overview

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.

Interventions

  • Procedure 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.
  • Procedure Brain and Skin Biopsy
    Brain and skin biopsy's may be taken during the VP shunt to assist in histological analysis for neurodegenerative changes.
  • Diagnostic test MRI Brain
    MRI brain with diffusion imagining will be performed before and after shunt surgery.

Primary outcome measures

  • White Matter Pathway Diffusion Metrics [Time frame: Perioperative]
Secondary outcome measures (12)
  • 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.]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United Kingdom · 1 center
  • Imperial College Healthcare NHS Trust — London

Identifiers

NCT: NCT07103681 · 311620 · W0300981

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗