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Идёт набор NCT06478979

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

Без фазы С лечением Idiopathic Normal Pressure Hydrocephalus (iNPH)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Neuclare.
Кому может быть актуально
Состояния в реестре: Idiopathic Normal Pressure Hydrocephalus (iNPH). Базовые параметры: 60 лет — 90 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

  • Устройство 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).

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

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

Идентификаторы

NCT: NCT06478979 · Deepsonbio_Neuclare_iNPH

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗