NCT05448768

Cognitive Effects and Potential Mechanisms of TBS in Subjects With MCI

Biomarker-based Prediction of Cognitive Effects and Potential Mechanisms of Theta-burst Stimulation (TBS) in Subjects With Mild Cognitive Impairment (MCI)

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study aims to examine the effects and potential mechanisms of theta-burst stimulation (TBS) on cognitive function in individuals with mild cognitive impairment (MCI).

Detailed description

The investigators apply the NIA-AA criteria to subtype different endophenotypes of biomarker-defined MCI individuals. This is a prospective, open-label clinical trial, and combined functional neuroimaging study of 18F-FDG-PET to further explore the potential mechanisms. A total of 80 MCI patients will be consecutively recruited and be subjected to iTBS for 5 daily interventions per week for two consecutive weeks. Cognitive evaluation will be performed before and immediately after TBS intervention, and 8 weeks after TBS. Data on functional neuroimaging will be also collected before and after TBS protocol.

Conditions

• Mild Cognitive Impairment

Interventions

Type	Name	Description
DEVICE	TBS for Amyloid-positive MCI	The investigators will perform standard intermittent TBS (iTBS) parameters to left DLPFC of every patient in the study. The frequency parameters of TBS are 3-pulse 50-Hz bursts, every 200 ms at 5 Hz, and the intensity is 90% of active motor threshold. A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times. In this study, The investigators will give two sessions of iTBS separated by 15 min.
DEVICE	TBS for Amyloid-negative MCI	The investigators will perform standard intermittent TBS (iTBS) parameters to left DLPFC of every patient in the study. The frequency parameters of TBS are 3-pulse 50-Hz bursts, every 200 ms at 5 Hz, and the intensity is 90% of active motor threshold. A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times. In this study, The investigators will give two sessions of iTBS separated by 15 min.

Timeline

• Start date: 2022-09-13
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2022-07-07
• Last updated: 2026-03-23

Locations

1 site across 1 country: Taiwan