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

NCT06478979 | Recruiting

• 1 other identifier: Deepsonbio_Neuclare_iNPH
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

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

  Week 1

Secondary Outcomes (7)

• Change of 10m gait : From Baseline to Week 1

  Week 1

• Change of iNPH grading scale : From Baseline to Week 1

  Week 1

• Change of Trail Making Test Black & White Score : From Baseline to Week 1

  Week 1

• Change of Modified Rankin Scale(mRS) : From Baseline to Week 1

  Week 1

• Change of Quality of life-AD Score : From Baseline to Week 1

  Week 1

Study Arms (1)

Treatment group

EXPERIMENTAL

The patient with Idiopathic Normal Pressure Hydrocephalus (iNPH) who will be treated with the medical device-Neuclare

Device: Neuclare

Interventions

Neuclare DEVICE

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).

Treatment group

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• A person with a severe history of cancer/tuberculosis
• A person who has contact dermatitis or sensitive skin abnormalities
• Patients with a high fever of 40 degrees Celsius or higher based on eardrum body temperature
• A person whose bleeding is identified due to a common procedure or surgery that may affect vital signs
• A person who is unable to perform MRI tests
• A person with an allergic reaction to MRI contrast agents such as Definity or Gadovist.
• Other cases where the investigator judged that it is difficult to participate in the study
• Patient with behavioral and psychological symptoms of dementia (BPSD) that make cooperation in the clinical trial difficult
• Patients with severe cognitive impairment, defined as an MMSE score of 17 or below
• Patients who have undergone shunt surgery in the past year
• Patients with a history of uncontrolled thyroid, liver, or kidney dysfunction
• Patients taking medications that affect gait, cognition, or urinary tract function and who have had a change in medication regimen within the past 3 months.

Sponsors & Collaborators

• Deepsonbio: lead

Study Sites (1)

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, Gyeonggi-do, 18450, South Korea

RECRUITING

Study Officials

• Jaeho Kim, M.D. Ph.D

  Hallym University Dongtan Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jandi Kim

CONTACT

+82-70-7722-3468; jandis2@deepsonbio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: June 27, 2024
• Study Start: July 22, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)