White Matter Distortion and Dementia Biomarkers in Normal Pressure Hydrocephalus (NPH) (NCT07103681) | Clinical Trial Compass
RecruitingNot Applicable
White Matter Distortion and Dementia Biomarkers in Normal Pressure Hydrocephalus (NPH)
United Kingdom100 participantsStarted 2025-03-25
Plain-language 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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.