RecruitingNot ApplicableNCT06608316

Intermittent Theta-burst Stimulation for Mild Cognitive Impairment

Optimizing Intermittent Theta-burst Stimulation for Enhancing Dual-Task Walking, Cognitive, and Physical Function in Mild Cognitive Impairment: a Randomized Double-Blind Controlled Trial

Sponsor

The Hong Kong Polytechnic University

Enrollment

66 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

Mild Cognitive Impairment (MCI)

Summary

The objectives of this study are to: 1. Evaluating the Impact of iTBS on Cognitive and Physical Functions: The investigators will investigate the efficacy of intermittent theta burst stimulation (iTBS) in patients with mild cognitive impairment (MCI), focusing on its effects on dual-task walking abilities, balance abilities, and cognitive function. 2. Comparing Clinical Efficacy Based on Stimulation Sites: The investigators will compare the clinical efficacy of iTBS targeting the left dorsolateral prefrontal cortex (DLPFC) versus bilateral DLPFC stimulation. This comparison aims to directly examine potential differences in therapeutic outcomes based on the site of stimulation. 3. Investigating Neurophysiological Mechanisms: The investigators plan to elucidate the neurophysiological mechanisms underlying the improvements in cognitive functions and dual-task walking abilities in MCI patients facilitated by iTBS. This will be achieved using fNIRS neuroimaging of brain activity.

Eligibility

Min Age: 65 Years

Inclusion Criteria5

Aged≥65 years;
Patient-reported subjective cognitive decline and the total score of the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) was between 19 and 25;
Intact daily functioning in ADL scales and being independent in daily living, and ability to walk at least for 1 minute independently without an assistive device;
No serious visual or hearing impairment and can complete relevant assessment and testing;
Signed informed consent of patients and their families for iTBS treatment.

Exclusion Criteria9

Identified with contraindications in the rTMS screening questionnaire;
Cognitive dysfunction due to craniocerebral trauma or neurological diseases;
Presence of severe physical illnesses such as speech disorders or unstable cardiac arrhythmias;
Currently in a critical condition such as fever, infection, or organ failure;
Significant damage to the left frontal lobe cortex;
Currently taking antidepressants or psychostimulants;
Unstable vital signs or organ failure;
Neuropsychiatric comorbidity or affective disorder that could affect the test results;
Patients with dementia.

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Interventions

DEVICEIntermittent Theta Burst Stimulation

A novel transcranial magnetic stimulation protocol called intermittent theta pulse stimulation (iTBS) effectively mimics the brain's naturally occurring theta rhythms and promotes significant synaptic changes. Compared to traditional stimulation methods, iTBS is more effective at initiating long-term potential (LTP) and produces significant excitatory effects in a shorter period of time.