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

Recruiting now · Not applicable

Conditions studied: Idiopathic Normal Pressure Hydrocephalus (iNPH)

In brief

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.

Key facts

Study ID

NCT06478979

Run by

Deepsonbio

People needed

20

Starts

2024-07-22

Expected to finish

2026-01-01

Last updated by the study team

2024-12-30

Who can join

Age: 60 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Hallym University Dongtan Sacred Heart Hospital — Hwaseong-si, Gyeonggi-do, South Korea (enrolling)

Full record on ClinicalTrials.gov

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