UnknownNot Applicable

Adjustable Gravitational vs. Adjustable Differential Pressure Valves in iNPH

Czechia40 participantsStarted 2020-01-01

Plain-language summary

The goal of the study is to verify theoretical benefit of ventriculoperitoneal shunting with MIETHKE M.blue® valve in patients with iNPH. The study is designed to assess walking and balance, urinary function, cognitive performance and quality of life before and after shunting and compare the results between the patients with MIETHKE M.blue® and MIETHKE proGAV 2.0® (with SA 2.0®) valves.

Who can participate

Age range

60 Years – 85 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.

Inclusion Criteria: * Age of patients (between 60 and 85 years old) * Clinically suspected Normal Pressure Hydrocephalus (NPH) with at least gait and one other symptom from Hakim-Adams triad (incontinence or dementia) * maximal initial pressure of 20 cmH2O during lumbar infusion test * Rout during LIT \>9mmHg/ml\*min * at least 15% improvement in Gait scale score after ELD * Conclusion of neuropsychological examination suggestive of iNPH (based on MoCA, Test of phonemic and verbal fluency, RAVLT, ROCFT, TMT A and B, Subtest of WAIS III, GDS) Exclusion Criteria: * Aetiology of hydrocephalus other than idiopathic normal pressure hydrocephalus (secondary normal pressure hydrocephalus - history of meningitis or subarachnoid haemorrhage, obstructive type of hydrocephalus - eg aqueductal stenosis, Blake's pouch cyst) * Intracranial tumor * Other neurodegenerative diseases may be present (AD, Parkinson's disease, Lewy body dementia, Progressive supranuclear palsy and cerebrovascular diseases), however have to be mild and evaluated in neurological, neuropsychological examinations and on MRI

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.

What they're measuring

Change in the Dutch Gait scale in MIETHKE M.blue® vs. MIETHKE proGAV 2.0® (with SA 2.0®)

Timeframe: Month 3/Year 1

Change in MoCA in MIETHKE M.blue® vs. MIETHKE proGAV 2.0® (with SA 2.0®)

Timeframe: Month 3/Year 1

Change in ICIQ UI-SF in MIETHKE M.blue® vs. MIETHKE proGAV 2.0® (with SA 2.0®)

Timeframe: Month 3/Year 1

Change in Kiefer Score in MIETHKE M.blue® vs. MIETHKE proGAV 2.0® (with SA 2.0®)

Timeframe: Month 3/Year 1

Change in SF12 v 2.0 Health Survey in MIETHKE M.blue® vs. MIETHKE proGAV 2.0® (with SA 2.0®)

Timeframe: Month 3/Year 1

Trial details

NCT IDNCT04434053

SponsorMilitary University Hospital, Prague

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01-01

Contact for this trial

Ondřej Bradáč, M.D, M.Sc., Ph.D

+420777600923 ondrej.bradac@uvn.cz

View on ClinicalTrials.gov More Normal Pressure Hydrocephalus trials

Plain-language summary

Who can participate

Age range

60 Years – 85 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.

What they're measuring

Change in the Dutch Gait scale in MIETHKE M.blue® vs. MIETHKE proGAV 2.0® (with SA 2.0®)

Timeframe: Month 3/Year 1

Change in MoCA in MIETHKE M.blue® vs. MIETHKE proGAV 2.0® (with SA 2.0®)

Timeframe: Month 3/Year 1

Change in ICIQ UI-SF in MIETHKE M.blue® vs. MIETHKE proGAV 2.0® (with SA 2.0®)

Timeframe: Month 3/Year 1

Change in Kiefer Score in MIETHKE M.blue® vs. MIETHKE proGAV 2.0® (with SA 2.0®)

Timeframe: Month 3/Year 1

Change in SF12 v 2.0 Health Survey in MIETHKE M.blue® vs. MIETHKE proGAV 2.0® (with SA 2.0®)

Timeframe: Month 3/Year 1