Actively Recruiting
Pilot Study of Neuclare Device for Gait and Cognitive Improvement in Idiopathic Normal Pressure Hydrocephalus A Prospective, Single-arm Clinical Trial Evaluating Neuclare's Safety and Effects in iNPH Patients
Led by Deepsonbio · Updated on 2024-12-30
20
Participants Needed
1
Research Sites
75 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Neuclare, a medical device designed to improve walking ability in patients with Idiopathic Normal Pressure Hydrocephalus (iNPH). This condition involves symptoms like walking difficulties, cognitive problems, and urinary incontinence. The study uses tests such as the Timed Up & Go Test, 10-meter walking test, and iNPH grading scale to measure changes in gait before and after using Neuclare. The Neuclare device stimulates the brain for a certain period aimed at assessing improvements in walking for patients with iNPH. This is a single-arm, open-label trial without randomization. Participants will use Neuclare as part of the study to observe any changes in gait and cognitive function. During the study, participants will be evaluated using clinical tests like the Timed Up & Go Test to measure walking ability, along with other assessments related to gait and cognition. Researchers will monitor safety and effectiveness throughout the trial. The main outcome measured is the change in the Timed Up & Go Test from the start of the study to one week after the intervention. Participants are adults aged 60 to 90 years with specific inclusion criteria related to iNPH symptoms and diagnosis.
CONDITIONS
Official Title
The Pilot Study of Medical Device-Neuclare for Patients With Idiopathic Normal Pressure Hydrocephalus (iNPH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 60 to 90, regardless of gender
- Individuals with gait disturbances plus cognitive impairment or urinary incontinence
- Evans' index greater than 0.3
- Symptoms not fully explained by other neurological or non-neurological diseases
- Diagnosis of iNPH based on Investigator's clinical judgement and iNPH Guidelines
You will not qualify if you...
- Brain lesions identified by MRI such as cerebral edema, hemorrhage, infarction, malformation, or tumor
- Metabolic disorders like thyroid dysfunction, hyperglycemia, hypoglycemia, liver or kidney dysfunction
- Long-term use of drugs causing cognitive decline such as anticholinergic drugs
- History of psychiatric disorders not included in the study criteria
- Severe history of cancer or tuberculosis
- Contact dermatitis or sensitive skin abnormalities
- High fever of 40°C or higher
- Bleeding affecting vital signs due to procedures or surgery
- Unable to undergo MRI tests
- Allergic reactions to MRI contrast agents
- Behavioral and psychological symptoms of dementia preventing cooperation
- Severe cognitive impairment with MMSE score 17 or below
- Shunt surgery within the past year
- Uncontrolled thyroid, liver, or kidney dysfunction
- Medication changes affecting gait, cognition, or urinary function within past 3 months
- Cerebrospinal fluid drainage test within the past month
- Other conditions judged by investigator to make participation difficult
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, South Korea, 18450
Actively Recruiting
Research Team
J
jandi Kim
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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