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RECRUITING
NCT07103681

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

Sponsor: Imperial College London

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2025-03-25

Completion Date

2029-02

Last Updated

2026-03-27

Healthy Volunteers

Yes

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.

Locations (1)

Imperial College Healthcare NHS Trust

London, United Kingdom