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The Efficacy and Safety of tDCS in Patients With Mild Dementia | Clinical Trials | Clareo Health

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The Efficacy and Safety of tDCS in Patients With Mild Dementia

In a Patient With Mild Dementia, Improvement of Cognitive Function Using YMS-201B, To Evaluate the Effectiveness and Safety, Randomized, Double-blinded, Sham Control Comparison, Confirmatory

NCT05495113•Ybrain Inc.

View on ClinicalTrials.gov

Summary

This study evaluated the effectiveness and safety of improving Mild Dementia by applying tDCS for 26 weeks to patients with Mild Dementia.

Detailed Description

Patients received tDCS for 30 minutes with an intensity of 1.5 to 2 mA. tDCS was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC) 5\~7 times a week and they were evaluated every 26weeks through questionnaires.

Eligibility

Age

55 - 90 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Men and women aged 55 to 90 years old.
•Those diagnosed with dementia (major neurocognitive disorder, neurocognitive disorder) according to the criteria of Diagnostic and Statistical Manual (DSM-V) or The International Statistical Classification of Diseases and Related Health Provisions (ICD-10).
•Patients with mild dementia with a MMSE (Mini Mental State Examination) score of 18 points or more and less than 26 points) and less than 26 points.
•Person who has a clinical dementia rating (CDR) global score of 0.5 or 1.0, while CDR-SOB (Sum of Boxes) score satisfies 0.5 to 4.0 points 2)
•Acetylcholinease inhibitors (ACEI) and NMDA receptor inhibitors are those with the same usage and capacity for at least 3 months from the date of screening.
•\* Patients who are taking drugs for cognitive functional treatment (e.g., pregabalin, gabapentincholinephocerate, etc.) other than acetylcholine inhibitor and NMDA receptor antagonist, and drugs for chronic diseases including hypertension, diabetes, hyperlipidemia, thyroid disease, etc.
•A person who can read and understand the subject's explanation and consent form, and who can speak at the level of ability to respond to questionnaires.
•A person who can be accompanied by a guardian when visiting a research institute during the clinical trial process, and who can help the guardian to proceed with the clinical trial process normally.
•A person who voluntarily decided to participate in this clinical trial and agreed in writing to the subject's written consent, who can participate in the pre-clinical trial period.

Exclusion Criteria

•A person with a history of uniaxial psychiatric diseases including intellectual disability, schizophrenia, alcoholism, and bipolar disorder in the past.
•A person who has a history of convulsions within 5 years of screening.
•Those who have been diagnosed with severe cerebrovascular stenosis, subdural hemorrhage, brain tumor, and brain abscess through transient ischemic attack, stroke or MRI within one year from the screening date and are considered inappropriate for participation in this test.
•A person who has cerebral damage due to trauma, ischemia, hypoxia, etc.
•A person who has been hospitalized for mental or emotional problems within 5 years of screening.
•A person who abused drugs within 5 years of screening.
•A person who received treatment for alcoholism within 5 years of screening.
•A person who can't read even with glasses on due to poor eyesight.
•A person who can't understand a conversation because of hearing impairment even when wearing a hearing aid.
•A person who has difficulty breathing when sitting still.
+8 more criteria

Locations (2)

The Catholic University of Korea at incheon

Incheon, South Korea

Korea University

Seoul, South Korea

Key Dates

Start Date

December 1, 2019

Primary Completion Date

September 30, 2022

Completion Date

December 30, 2022

Last Updated

September 28, 2022

Enrollment

118

ESTIMATED participants

Conditions

Mild Dementia

Interventions

YMS-201B (Device: Mind STIM)

DEVICE

Sham stimulation using YMS-201B

DEVICE

Contacts

Kiwon Lee, PhD

CONTACT

+82-10-3911-3010 kwanghyuk.lee@ybrain.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 28, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Efficacy and Safety of tDCS in Patients With Mild Dementia

Inclusion Criteria

Exclusion Criteria

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