ITBS in MCI and Mild AD

National Defense Medical Center, Taiwan

Status: Not yet enrolling

Conditions: Mild Cognitive Impairment (MCI); Mild Alzheimer Disease

Treatments: Device: Sham rTMS; Device: Active rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT06670820

A202305164

Details and patient eligibility

About

This study aims to examine the effects of iTBS on cognitive function in individuals with MCI or mild AD, with a secondary objective of exploring prefrontal TBS mechanisms for cognitive function and the effect of iTBS on BDNF.

Enrollment: 80 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of MCI (overall Clinical Dementia Rating of 0.5)
• Clinical diagnosis of mild Alzheimer's Disease (overall Clinical Dementia Rating of 0.5 or 1)

Exclusion criteria

• History of stroke
• History of uncontrol seizure
• History of significant head trauma followed by persistent neurologic deficit or known structural brain abnormality
• Mental illness
• Drug abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Active iTBS for Patients With MCI or AD

Active Comparator group

Description:

The patient will receive one daily rTMS session for 10 days of iTBS, delivered through an H-coil applied to the left dorsolateral prefrontal cortex. The TBS frequency parameters consist of 3-pulse 50-Hz bursts every 200 ms at 5 Hz, and the intensity will be set at 80% of the active motor threshold (AMT). A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times.

Treatment:

Device: Active rTMS

Sham iTBS for Patients With MCI or AD

Sham Comparator group

Description:

Sham stimulation will be delivered 10 sessions.

Treatment:

Device: Sham rTMS