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New treatment option for Idiopathic Normal Pressure Hydrocephalus (iNPH)
Official title The Pilot Study of Medical Device-Neuclare for Patients With Idiopathic Normal Pressure Hydrocephalus (iNPH)
ClinicalTrials.gov ID: NCT06478979
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 90
You may be able to join 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 likely can't join 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...
- Patients with metabolic disorders such as thyroid dysfunction, hyperglycemia, hypoglycemia, liver or kidney dysfunction, and long-term use of drugs...
- History of psychiatric disorder other than the inclusion criteria.
- A person with a severe history of cancer/tuberculosis
- A person who has contact dermatitis or sensitive skin abnormalities
See the full eligibility criteria
- 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
- 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)
- History of psychiatric disorder other than the inclusion criteria.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hwaseong-si, Gyeonggi-do, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hwaseong-si, Gyeonggi-do, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.