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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Neuclare
DeviceIt is used to stimulate the brain for a certain period of time to assess gait improvement in patients with Idiopathic Normal Pressure Hydrocephalus (iNPH). In this clinical trial, it is used for patients with Idiopathic Normal Pressure Hydrocephalus (iNPH).
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change of Time Up & Go Test : From Baseline to Week 1
Compare with before and after using Neuclare for the treatment of Idiopathic Normal Pressure Hydrocephalus (iNPH) as evaluated by Time Up \& Go Test
Time frame
Week 1Secondary outcomes
1
Change of 10m gait : From Baseline to Week 1
Compare with before and after using Neuclare for the treatment of Idiopathic Normal Pressure Hydrocephalus (iNPH) as evaluated by 10m gait
Time frame
Week 12
Change of iNPH grading scale : From Baseline to Week 1
Compare with before and after using Neuclare for the treatment of Idiopathic Normal Pressure Hydrocephalus (iNPH) as evaluated by iNPH grading scale. The overall score may reach values between 0 and 12, with higher scores indicating more severe impairment
Time frame
Week 13
Change of Trail Making Test Black & White Score : From Baseline to Week 1
Compare with before and after using Neuclare for the treatment of Idiopathic Normal Pressure Hydrocephalus (iNPH) as evaluated by Change of Trail Making Test Black \& White Score. The higher scores mean a worse outcome.
Time frame
Week 14
Change of Modified Rankin Scale(mRS) : From Baseline to Week 1
Compare with before and after using Neuclare for the treatment of Idiopathic Normal Pressure Hydrocephalus (iNPH) as evaluated by Modified Rankin Scale(mRS). Assessment results range from 0-6 points，a higher score means a worse ending
Time frame
Week 1 Source ClinicalTrials.gov