NCT06478979

The Pilot Study of Medical Device-Neuclare for Patients With Idiopathic Normal Pressure Hydrocephalus (iNPH)

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Deepsonbio · Industry
• Sex: All
• Age: 60 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Normal Pressure Hydrocephalus (iNPH)

Interventions

Type	Name	Description
DEVICE	Neuclare	It 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).

Timeline

• Start date: 2024-07-22
• Primary completion: 2025-12-01
• Completion: 2026-01-01
• First posted: 2024-06-27
• Last updated: 2024-12-30

Locations

1 site across 1 country: South Korea