The Pilot Study of Medical Device-Neuclare for Patients With Idiopathic Normal Pressure Hydrocephalus (iNPH)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-90
SponsorDeepsonbio
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Neuclare
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov