The Pilot Study of Medical Device-Neuclare for Patients With Idiopathic Normal Pressure Hydrocephalus (iNPH)
NCT Number: NCT06478979
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Idiopathic Normal Pressure Hydrocephalus (iNPH)
Interventions: DEVICE: Neuclare
Sponsor: Deepsonbio
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-22
Completion Date: 2026-01-01
Locations: Hallym University Dongtan Sacred Heart Hospital, Hwaseong-si, Gyeonggi-do, 18450, Korea, Republic of

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.

Primary Outcome Measures: 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, Week 1
Secondary Outcome Measures: 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, Week 1|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, Week 1|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., Week 1|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, Week 1|Change of Quality of life-AD 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 Quality of life-AD Score.

QoL-AD was comprised of 13 individual items, each measured on a 4-point Likert scale (ranging from 1 \[poor\] to 4 \[excellent\]). Overall QoL-AD score was the sum of the scores for the 13 individual items and ranged from 13 to 52, with higher scores indicating a higher health related quality of life., Week 1|Change of MMSE-II Score : From Baseline to Week 5, Compare with before and after using Neuclare for the treatment of Idiopathic Normal Pressure Hydrocephalus (iNPH) as evaluated by Change of MMSE-II Score.

The cognitive function evaluation performed by MMSE test. The Total score range of MMSE is 0-30, and the higher score indicates better cognitive functions., Week 1|Change in glymphatic activity measured by MRI: 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 in glymphatic activity measured by MRI, Week 1