Evaluating the Neuclare device for improving gait in patients with idiopathic normal pressure hydrocephalus
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 study is testing if the Neuclare device can help improve walking for older adults with idiopathic normal pressure hydrocephalus who have trouble with their gait.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 60 Years to 90 Years |
| Sex | All |
| Sponsor | Deepsonbio Industry-sponsored |
| Locations | 1 site (Hwaseong-si, Gyeonggi-do) |
| Trial ID | NCT06478979 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness and safety of the Neuclare medical device in enhancing gait for patients diagnosed with Idiopathic Normal Pressure Hydrocephalus (iNPH). Participants aged 60 to 90 with gait disturbances and additional symptoms such as cognitive impairment or urinary incontinence will be evaluated using various tests, including the Timed Up & Go Test and the iNPH grading scale. The study aims to assess gait improvement before and after the use of the Neuclare device, providing insights into its potential benefits for this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 60 to 90 with gait disturbances and at least one additional symptom related to iNPH.
Not a fit: Patients with significant brain lesions or other neurological disorders that explain their symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved mobility and quality of life for patients suffering from iNPH.
How similar studies have performed: While this approach is novel, similar studies exploring gait improvement in neurological conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hwaseong-si, Gyeonggi-do
- Hallym University Dongtan Sacred Heart Hospital — Hwaseong-si, Gyeonggi-do, South Korea (Recruiting)
Study contacts
- Principal investigator: Jaeho Kim, M.D. Ph.D — Hallym University Dongtan Sacred Heart Hospital
- Study coordinator: jandi Kim
- Email: jandis2@deepsonbio.com
- Phone: +82-70-7722-3468
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.