Actively Recruiting

Phase Not Applicable
Age: 60Years - 90Years
All Genders
NCT06478979

The Pilot Study of Medical Device-Neuclare for Patients With Idiopathic Normal Pressure Hydrocephalus (iNPH)

Led by Deepsonbio · Updated on 2024-12-30

20

Participants Needed

1

Research Sites

75 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This clinical trial aims to explore the effectiveness and safety of gait improvemen of Neuclare, a science medical device, for patients with Idiopathic Normal Pressure Hydrocephalus (iNPH) Through methods such as Timed Up \& Go Test (TUG), 10m gait , iNPH grading scale), etc, gait improvement before and after using Neuclare will be evaluated.

CONDITIONS

Official Title

The Pilot Study of Medical Device-Neuclare for Patients With Idiopathic Normal Pressure Hydrocephalus (iNPH)

Who Can Participate

Age: 60Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 60 to 90, regardless of gender
  • Individuals with gait disturbances plus cognitive impairment or urinary incontinence
  • Evans' index greater than 0.3
  • Symptoms not fully explained by other neurological or non-neurological diseases
  • Diagnosis of iNPH based on Investigator's clinical judgement and iNPH Guidelines
Not Eligible

You will not qualify if you...

  • Brain lesions identified by MRI such as cerebral edema, hemorrhage, infarction, malformation, or tumor
  • Metabolic disorders like thyroid dysfunction, hyperglycemia, hypoglycemia, liver or kidney dysfunction
  • Long-term use of drugs causing cognitive decline such as anticholinergic drugs
  • History of psychiatric disorders not included in the study criteria
  • Severe history of cancer or tuberculosis
  • Contact dermatitis or sensitive skin abnormalities
  • High fever of 40°C or higher
  • Bleeding affecting vital signs due to procedures or surgery
  • Unable to undergo MRI tests
  • Allergic reactions to MRI contrast agents
  • Behavioral and psychological symptoms of dementia preventing cooperation
  • Severe cognitive impairment with MMSE score 17 or below
  • Shunt surgery within the past year
  • Uncontrolled thyroid, liver, or kidney dysfunction
  • Medication changes affecting gait, cognition, or urinary function within past 3 months
  • Cerebrospinal fluid drainage test within the past month
  • Other conditions judged by investigator to make participation difficult

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, Gyeonggi-do, South Korea, 18450

Actively Recruiting

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Research Team

J

jandi Kim

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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