Can a Brain-Zapping device restore steady steps and sharp thinking?
NCT ID NCT06478979
First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time
Summary
This trial is testing a device called Neuclare, which stimulates the brain, to see if it can improve walking and thinking in people with idiopathic normal pressure hydrocephalus (iNPH), a condition that causes gait problems, memory issues, and sometimes incontinence. The study will enroll 20 adults aged 60 to 90 who have these symptoms. Participants will use the device for a week, and researchers will measure changes in walking speed, balance, and cognitive function before and after use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Neuclare, a medical device that stimulates the brain
- What this could lead to
- If effective, Neuclare could offer a non-invasive way to improve walking and cognitive symptoms in people with iNPH, potentially reducing the need for surgery.
- What could go wrong
- This is a small, early exploratory trial with only 20 participants, so results may not be conclusive. The device's safety and effectiveness are not yet established, and individual responses may vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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20 people
The number who actually took part.
- Started
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Jul 2024
- Finished
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Nov 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, 18450, South Korea
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Other studies related to the condition(s) this trial covers.
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