The Pilot Study of Medical Device-Neuclare for Patients With Idiopathic Normal Pressure Hydroceph… (NCT06478979) | Clinical Trial Compass
RecruitingNot Applicable
The Pilot Study of Medical Device-Neuclare for Patients With Idiopathic Normal Pressure Hydrocephalus (iNPH)
South Korea20 participantsStarted 2024-07-22
Plain-language summary
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.
Who can participate
Age range60 Years – 90 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Change of Time Up & Go Test : From Baseline to Week 1