NCT05495113

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (estimated)
• Sponsor: Ybrain Inc. · Industry
• Sex: All
• Age: 55 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mild Dementia

Interventions

Type	Name	Description
DEVICE	YMS-201B (Device: Mind STIM)	transcranial Direct Current Stimulation (tDCS) 2mA for 30 min; 30 sec of ramp-up and -down; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)
DEVICE	Sham stimulation using YMS-201B	Sham stimulation; only 30 sec of ramp-up and -down; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)

Timeline

• Start date: 2019-12-01
• Primary completion: 2022-09-30
• Completion: 2022-12-30
• First posted: 2022-08-10
• Last updated: 2022-09-28

Locations

2 sites across 1 country: South Korea