A Prospective, Single-arm, Open-label, Non-randomized Exploratory Clinical Trial to Verify the Efficacy and Safety of Gait and Cognitive Improvement in Patients With Idiopathic Normal Pressure Hydrocephalus (iNPH) Using the Neuclare Physical Device for Medical Use

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Hallym University Dongtan Sacred Heart Hospital
RECRUITING
Hwaseong-si
Contact Information
Primary
jandi Kim
jandis2@deepsonbio.com
+82-70-7722-3468
Time Frame
Start Date: 2024-07-22
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 20
Treatments
Experimental: Treatment group
The patient with Idiopathic Normal Pressure Hydrocephalus (iNPH) who will be treated with the medical device-Neuclare
Sponsors
Leads: Deepsonbio

This content was sourced from clinicaltrials.gov