Idiopathic Normal Pressure Hydrocephalus (iNPH)NCT06478979
The Pilot Study of Medical Device-Neuclare for Patients With Idiopathic Normal Pressure Hydrocephalus (iNPH)
A study testing Neuclare in people with Idiopathic Normal Pressure Hydrocephalus (iNPH), run by Deepsonbio at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Idiopathic Normal Pressure Hydrocephalus (iNPH)
- What is being tested?
- Neuclare
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Jul 2024to 21 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, 18450
About this study
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
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.
- Being tested
- Neuclare
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuclareDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | The patient with Idiopathic Normal Pressure Hydrocephalus (iNPH) who will be treated with the medical device-Neuclare Receives: Device: Neuclare |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 1
Secondary outcomes (7)
Change of 10m gait : From Baseline to Week 1
Compare with before and after using Neuclare for the treatment of Idiopathic Normal Pressure Hydrocephalus (iNPH) as evaluated by 10m gait
Measured: Week 1
Change of iNPH grading scale : From Baseline to Week 1
Compare with before and after using Neuclare for the treatment of Idiopathic Normal Pressure Hydrocephalus (iNPH) as evaluated by iNPH grading scale.
The overall score may reach values between 0 and 12, with higher scores indicating more severe impairment
Measured: Week 1
Change of Trail Making Test Black & White Score : From Baseline to Week 1
Compare with before and after using Neuclare for the treatment of Idiopathic Normal Pressure Hydrocephalus (iNPH) as evaluated by Change of Trail Making Test Black \& White Score.
The higher scores mean a worse outcome.
Measured: Week 1
Change of Modified Rankin Scale(mRS) : From Baseline to Week 1
Compare with before and after using Neuclare for the treatment of Idiopathic Normal Pressure Hydrocephalus (iNPH) as evaluated by Modified Rankin Scale(mRS).
Assessment results range from 0-6 points，a higher score means a worse ending
Measured: Week 1
Change of Quality of life-AD Score : From Baseline to Week 1
Compare with before and after using Neuclare for the treatment of Idiopathic Normal Pressure Hydrocephalus (iNPH) as evaluated by Change of Quality of life-AD Score.
QoL-AD was comprised of 13 individual items, each measured on a 4-point Likert scale (ranging from 1 [poor] to 4 [excellent]). Overall QoL-AD score was the sum of the scores for the 13 individual items and ranged from 13 to 52, with higher scores indicating a higher health related quality of life.
Measured: Week 1
Change of MMSE-II Score : From Baseline to Week 5
Compare with before and after using Neuclare for the treatment of Idiopathic Normal Pressure Hydrocephalus (iNPH) as evaluated by Change of MMSE-II Score.
The cognitive function evaluation performed by MMSE test. The Total score range of MMSE is 0-30, and the higher score indicates better cognitive functions.
Measured: Week 1
Change in glymphatic activity, structure, functional connectivity measured by MRI: From Baseline to Week 1
Compare with before and after using Neuclare for the treatment of Idiopathic Normal Pressure Hydrocephalus (iNPH) as evaluated by Change in glymphatic activity, structure, functional connectivity measured by MRI
Measured: Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start22 Jul 2024
- Primary completion21 Nov 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Normal Pressure Hydrocephalus (iNPH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deepsonbio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaeho Kim, M.D. Ph.D, Principal investigator, Hallym University Dongtan Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478979
- Sponsor's protocol ID
- Deepsonbio_Neuclare_iNPH
- Status last verified
- Aug 2026
- First submitted
- 23 Jun 2024
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06478979
- Acronym / sponsor ID
- Deepsonbio_Neuclare_iNPH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- DeepsonbioIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: NeuclareThe patient with Idiopathic Normal Pressure Hydrocephalus (iNPH) who will be treated with the medical device-Neuclare |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuclareIt 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). | Device | Treatment group |
Primary outcome
Change of Time Up & Go Test : From Baseline to Week 1
Time frame: 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
7 secondary outcomes
Change of 10m gait : From Baseline to Week 1
Time frame: Week 1
Change of iNPH grading scale : From Baseline to Week 1
Time frame: Week 1
Change of Trail Making Test Black & White Score : From Baseline to Week 1
Time frame: Week 1
Change of Modified Rankin Scale(mRS) : From Baseline to Week 1
Time frame: Week 1
Change of Quality of life-AD Score : From Baseline to Week 1
Time frame: Week 1
Change of MMSE-II Score : From Baseline to Week 5
Time frame: Week 1
Change in glymphatic activity, structure, functional connectivity measured by MRI: From Baseline to Week 1
Time frame: Week 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Idiopathic Normal Pressure Hydrocephalus (iNPH)
Not yet recruitingObservational study
Prediction of Response to Shunt Surgery in Normal Pressure Hydrocephalus Using Radscale and Lumbar Puncture
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Transcranial Ultrasound Assessment of Cerebral Pulsatility in Shunt Decision-making for Suspected Idiopathic Normal Pressure Hydrocephalus: a Prospective Cohort Study
Brain Pulsatility, Idiopathic Normal Pressure Hydrocephalus (INPH)
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Unsteady Gait in Older People May be a Common and Treatable Neurological Disease Associated With Increased Mortality
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Recruiting
Multi-omics Research of Idopathic Normal Pressure Hydrocephalus (iNPH)
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White Matter Distortion and Dementia Biomarkers in Normal Pressure Hydrocephalus (NPH)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaeho Kim, M.D. Ph.D principal investigator
Hallym University Dongtan Sacred Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuclare in people with Idiopathic Normal Pressure Hydrocephalus (iNPH), run by Deepsonbio at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Time Up & Go Test : From Baseline to Week 1 (time frame: Week 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.