Cognitive Effects and Potential Mechanisms of TBS in Subjects With MCI

Enrolling by invitation · Not applicable

Conditions studied: Mild Cognitive Impairment

In brief

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).

Key facts

Study ID

NCT05448768

Run by

Chang Gung Memorial Hospital

People needed

80

Starts

2022-09-13

Expected to finish

2027-06-30

Last updated by the study team

2026-03-23

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects aged 50-90 year
• Subjects meet Petersen's criteria for mild cognitive impairment (Petersen, Smith et al. 1999)
• The CDR of MCI patients can be 0-0.5
• Amyloid PET should ever be performed

You may not qualify if…

• Any subject has a definite diagnosis of epilepsy or history of seizure attack.
• Current or past history of clinically significant neurological insults affecting brain structure or function like completed stroke, head injury or brain tumor.
• Any subject has clinically significant or unstable medical diseases including metabolic, renal,liver, lung or cardiovascular disorders including metabolic, renal, liver, lung or cardiovascular disorders.
• Any subject has current alcohol or other substances abuse and/ or dependence within the recent one year, or prolonged history of major psychiatric disorder like schizophrenia,bipolar disorder, and previously prolonged substances abuse.
• Any females who is pregnant or lactating.
• General MRI, TMS and/or PET exclusion criteria including subjects who had received brain aneurysm surgery, or implanted pacemaker, mechanical valves, cochlear implant or other metal devices/ objects that are not MR compatible in the body.
• Withdrawal criteria
• Complications onset after intervention that affect efficacy and safety judgments.
• New onset or progression of disease that may affect outcomes.
• Use of other therapies or drugs during the intervention period to change cognitive functions.
• Any subjects who are recognized as high risk of adverse effects by principle investigator.

Where it is running

• Chang Gung Memorial Hospital — Taoyuan, Taiwan

Full record on ClinicalTrials.gov

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