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.