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

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

Recruiting
60-90 years
All
Phase N/A

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Overview

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.

Eligibility

Inclusion Criteria:

  • Adults aged 60 to 90, regardless of gender
  • Individuals exhibiting gait disturbances along with at least one of the following symptoms: cognitive impairment or urinary incontinence
  • Evans' index > 0.3)
  • When the symptoms in 2) and 3) cannot be fully explained by other neurological or non-neurological diseases
  • Diagnosis of INPH based on the Investigator's clinical judgement based on criteria as described in the INPH Guidelines

Exclusion Criteria:

  • Patient with pathological lesions in the brain identified by MRI
  • A person who is confirmed to have organic brain lesions (e.g., cerebral edema, cerebral hemorrhage, cerebral infarction, cerebrovascular malformation, brain tumor, etc.) on a brain MRI.
  • Patients with metabolic disorders such as thyroid dysfunction, hyperglycemia, hypoglycemia, liver or kidney dysfunction, and long-term use of drugs that will cause cognitive decline (e.g., anticholinergic drugs)
  • History of psychiatric disorder other than the inclusion criteria.
  • A person with a severe history of cancer/tuberculosis
  • A person who has contact dermatitis or sensitive skin abnormalities
  • Patients with a high fever of 40 degrees Celsius or higher based on eardrum body temperature
  • A person whose bleeding is identified due to a common procedure or surgery that may affect vital signs
  • A person who is unable to perform MRI tests
  • A person with an allergic reaction to MRI contrast agents such as Definity or Gadovist.
  • Other cases where the investigator judged that it is difficult to participate in the study
  • Patient with behavioral and psychological symptoms of dementia (BPSD) that make cooperation in the clinical trial difficult
  • Patients with severe cognitive impairment, defined as an MMSE score of 17 or below
  • Patients who have undergone shunt surgery in the past year
  • Patients with a history of uncontrolled thyroid, liver, or kidney dysfunction
  • Patients taking medications that affect gait, cognition, or urinary tract function and who have had a change in medication regimen within the past 3 months.
  • Patients who have undergone a cerebrospinal fluid drainage test within the past 1 month.

Study details
    Idiopathic Normal Pressure Hydrocephalus (iNPH)

NCT06478979

Deepsonbio

15 October 2025

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