Clinical trial NCT06478979: The Pilot Study of Medical Device-Neuclare for Patients With Idiopathic Normal Pressure Hydrocephalus (iNPH)
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Idiopathic Normal Pressure Hydrocephalus (iNPH)
Lead sponsor: Deepsonbio
Sponsor class: INDUSTRY
First posted: 2024-06-27
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change of Time Up & Go Test : From Baseline to Week 1
timeFrame: Week 1
Secondary outcomes:
measure: Change of 10m gait : From Baseline to Week 1
timeFrame: Week 1
measure: Change of iNPH grading scale : From Baseline to Week 1
timeFrame: Week 1
measure: Change of Trail Making Test Black & White Score : From Baseline to Week 1
timeFrame: Week 1
measure: Change of Modified Rankin Scale(mRS) : From Baseline to Week 1
timeFrame: Week 1
measure: Change of Quality of life-AD Score : From Baseline to Week 1
timeFrame: Week 1
measure: Change of MMSE-II Score : From Baseline to Week 5
timeFrame: Week 1
measure: Change in glymphatic activity, structure, functional connectivity measured by MRI: From Baseline to Week 1
timeFrame: Week 1
Other outcomes:
Locations:
city: Hwaseong-si
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital
state: Gyeonggi-do
Study officials:
affiliation: Hallym University Dongtan Sacred Heart Hospital
name: Jaeho Kim, M.D. Ph.D
role: PRINCIPAL_INVESTIGATOR
References: