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Recruiting NCT06478979

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

No phase Interventional Idiopathic Normal Pressure Hydrocephalus (iNPH)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neuclare.
Who it may be relevant to
Registry conditions: Idiopathic Normal Pressure Hydrocephalus (iNPH). Basic parameters: 60 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective, Single-arm, Open-label, Non-randomized Exploratory Clinical Trial to Verify the Efficacy and Safety of Gait and Cognitive Improvement in Patients With Idiopathic Normal Pressure Hydrocephalus (iNPH) Using the Neuclare Physical Device for Medical Use

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.

Interventions

  • Device Neuclare
    It is used to stimulate the brain for a certain period of time to assess gait improvement in patients with Idiopathic Normal Pressure Hydrocephalus (iNPH). In this clinical trial, it is used for patients with Idiopathic Normal Pressure Hydrocephalus (iNPH).

Primary outcome measures

  • Change of Time Up & Go Test : From Baseline to Week 1 [Time frame: Week 1]
Secondary outcome measures (7)
  • Change of 10m gait : From Baseline to Week 1 [Time frame: Week 1]
  • Change of iNPH grading scale : From Baseline to Week 1 [Time frame: Week 1]
  • Change of Trail Making Test Black & White Score : From Baseline to Week 1 [Time frame: Week 1]
  • Change of Modified Rankin Scale(mRS) : From Baseline to Week 1 [Time frame: Week 1]
  • Change of Quality of life-AD Score : From Baseline to Week 1 [Time frame: Week 1]
  • Change of MMSE-II Score : From Baseline to Week 5 [Time frame: Week 1]
  • Change in glymphatic activity, structure, functional connectivity measured by MRI: From Baseline to Week 1 [Time frame: Week 1]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Hallym University Dongtan Sacred Heart Hospital — Hwaseong-si

Identifiers

NCT: NCT06478979 · Deepsonbio_Neuclare_iNPH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗