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

Deepsonbio

Status

Enrolling

Conditions

Idiopathic Normal Pressure Hydrocephalus (iNPH)

Treatments

Device: Neuclare

Study type

Interventional

Funder types

Industry

Identifiers

NCT06478979

Deepsonbio_Neuclare_iNPH

Details and patient eligibility

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.

Enrollment

20 estimated patients

Sex

All

Ages

60 to 90 years old

Volunteers

No Healthy Volunteers

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.