Adjustable Gravitational vs. Adjustable Differential Pressure Valves in iNPH

NCT04434053 | Unknown

• 1 other identifier: MilitaryUHP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Normal Pressure Hydrocephalus

Keywords

iNPH

Outcome Measures

Primary Outcomes (5)

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

  The Gait Scale, a useful quantitative measure of gait impairment in NPH patients, is a component of a larger measure developed as part of the Dutch normal pressure hydrocephalus study (Boon et al., 1997). The Gait Scale evaluates various aspects of gait, including walking speed, number of steps, stride length, stance, foot-floor clearance, balance, tandem walking ability, turning ability, and start hesitation in 10m of walking. (Ravdin et al., 2008) The score consists of 3 subcategories and ranges 2-40 points with higher score indicating more severe impairment.

  Month 3/Year 1

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

  The Montreal Cognitive Assessment (MoCA) is a widely used screening assessment for detecting cognitive impairment. It was created in 1996 by Ziad Nasreddine in Montreal, Quebec. The MoCA assesses several cognitive domains. Score ranges 0-30 points with lower scores indicating more severely impaired cognitive skills.

  Month 3/Year 1

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

  The ICIQ-UI Short Form is a questionnaire for evaluating the frequency, severity, impact on quality of life (QoL) and simple estimation of a cause of urinary incontinence in men and women. The score ranges 0-21 points with higher score indicating more severe impairment.

  Month 3/Year 1

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

  The Kiefer is a modified clinical grading tool that measures the severity of the three key symptoms (mental deficits, gait disturbance, incontinence) and two additional minor symptoms (headache and dizziness). The overall score may reach values between 0 and 24, with higher scores indicating more severe impairment

  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®)

  The SF-12® V2 Health Survey (SF-12 v2.0) (Ware, Kosinski, Turner-Bowker, \& Gandek, 2002) is a 12-item questionnaire used to assess generic health outcomes from the patient's perspective. Generic patient-reported outcome (PRO) measures like the SF-12 assess general health and well-being \[or health-related quality of life (HRQOL)\], including the impact of any and all illnesses on a broad range of functional domains. The SF-12 v2 consists of a subset of 12 items from the SF-36® Health Survey (SF-36) (Ware \& Sherbourne, 1992; Ware, Snow, Kosinski, \& Gandek, 1993) covering the same eight domains of health outcomes, including physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH).

  Month 3/Year 1

Secondary Outcomes (4)

• Postoperative changes in valve settings in MIETHKE M.blue® vs. MIETHKE proGAV 2.0® (with SA 2.0®)

  1 Year

• Overdrainage in MIETHKE M.blue® vs. MIETHKE proGAV 2.0® (with SA 2.0®)

  1 Year

• Shunt revisions in MIETHKE M.blue® vs. MIETHKE proGAV 2.0® (with SA 2.0®)

  1 Year

• Shunt related infections in MIETHKE M.blue® vs. MIETHKE proGAV 2.0® (with SA 2.0®)

  1 Year

Study Arms (2)

MIETHKE M.blue®

EXPERIMENTAL

Device: MIETHKE M.blue®

MIETHKE proGAV 2.0® (with SA 2.0®)

ACTIVE COMPARATOR

Device: MIETHKE proGAV 2.0® (with SA 2.0®)

Interventions

MIETHKE M.blue® DEVICE

The programmable shunt will be adjusted through the MIETHKE M.blue® valve.

MIETHKE M.blue®

MIETHKE proGAV 2.0® (with SA 2.0®) DEVICE

The programmable shunt will be adjusted through the MIETHKE proGAV 2.0® valve that will be implanted together with a shunt-assistant SA 2.0®.

MIETHKE proGAV 2.0® (with SA 2.0®)

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Military University Hospital, Prague: lead

Study Sites (1)

Neurosurgical department of the Central Military Hospital, 1st Faculty of Medicine of Charles University

Prague, 16902, Czechia

RECRUITING

MeSH Terms

Conditions

Hydrocephalus, Normal Pressure

Condition Hierarchy (Ancestors)

Hydrocephalus; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Ondřej Bradáč, M.D, M.Sc., Ph.D

CONTACT

+420777600923; ondrej.bradac@uvn.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., M.Sc., Ph.D.

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 16, 2020
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2023
• Last Updated: June 16, 2020

Record last verified: 2020-06

Locations

CZ (1)