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

NCT07103681 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-03-27

No results posted yet for this study

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.

Conditions

  • Normal Pressure Hydrocephalus

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.

Sponsors & Collaborators

  • Medical Research Council

    collaborator OTHER_GOV

  • Michael J. Fox Foundation for Parkinson's Research

    collaborator OTHER

  • University College, London

    collaborator OTHER

  • University of Edinburgh

    collaborator OTHER

  • King's College London

    collaborator OTHER

  • Imperial College London

    lead OTHER

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-25
Primary Completion
2028-02-29
Completion
2029-02-28

Countries

  • United Kingdom

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07103681 on ClinicalTrials.gov