White matter damage and dementia markers in normal pressure hydrocephalus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center observational cohort will follow about 50 symptomatic adults with idiopathic or late-presenting communicating normal pressure hydrocephalus through initial assessment and, if performed, CSF shunt surgery, with two control groups of 50 asymptomatic chronic-hydrocephalus and 50 non-hydrocephalus participants. Participants undergo detailed gait, cognitive, urinary, and quality-of-life testing alongside diffusion MRI, blood and CSF biomarker sampling, and optional brain and skin biopsies. The study will also test the acceptability and data value of wearable activity and bed-sleep monitors and self-administered digital cognitive assessments before and after surgery. Clinical, imaging, and biomarker data will be stored in REDCap and analyzed to compare changes in shunt responders versus non-responders, with shunt response defined by gait speed improvement.

Why it matters

Who can join: the full rules

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

Where it's running

• Imperial College Healthcare NHS Trust
  London, United Kingdom Recruiting

Study contacts

• Study coordinator: Chris Carswell
• Email: NPH@imperial.ac.uk
• Phone: +44 20311 1234

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CSF Flow MRI to aid diagnosis and prognosis in normal pressure hydrocephalus

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• Evaluating gait changes in patients with normal pressure hydrocephalus using smart insoles

  This study is testing if a CSF tap can improve walking and balance in people with normal pressure hydrocephalus by using smart insoles to track their movements.

  Recruiting Yonsei University · Yongin-si, Gyeonggi-do · NCT06722768

• Comparing protein patterns in skin biopsies of neurodegenerative diseases

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  Recruiting Universidad Autonoma de San Luis Potosí · San Luis Potosí City · NCT06528964

• Investigating early signs of Normal Pressure Hydrocephalus

  This study is trying to see if special brain scans and tests on spinal fluid and blood can help predict how Normal Pressure Hydrocephalus develops in people who have early signs, those with symptoms, and healthy individuals over five years.

  Recruiting at 2 sites Uppsala University Hospital · Kuopio and 6 other locations · NCT05910944

• Sleep apnea and how it affects shunts in normal-pressure hydrocephalus

  This project will measure intracranial and intra-abdominal pressures during sleep in people with normal-pressure hydrocephalus to see if sleep apnea affects shunt function and whether treating sleep apnea improves symptoms.

  Recruiting University of Valencia · Valencia, Valencia · NCT04471740

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.