The Pilot Study of Medical Device-Neuclare for Patients With Idiopathic Normal Pressure Hydrocephalus (iNPH)
NCT ID: NCT06478979
Last Updated: 2024-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-07-22
2026-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment group
The patient with Idiopathic Normal Pressure Hydrocephalus (iNPH) who will be treated with the medical device-Neuclare
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
* Patients who have undergone a cerebrospinal fluid drainage test within the past 1 month.
Exclusion Criteria
* 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)
60 Years
90 Years
ALL
No
Sponsors
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Deepsonbio
INDUSTRY
Responsible Party
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Principal Investigators
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Jaeho Kim, M.D. Ph.D
Role: PRINCIPAL_INVESTIGATOR
Hallym University Dongtan Sacred Heart Hospital
Locations
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Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Jaeho Kim
Role: primary
Other Identifiers
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Deepsonbio_Neuclare_iNPH
Identifier Type: -
Identifier Source: org_study_id