Intermittent Theta-burst Stimulation for Mild Cognitive Impairment
Hong Kong66 participantsStarted 2024-11-01
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dual-task cost in cognition (Reaction time)
Timeframe: before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment
2
Dual-task cost in gait (gait speed)
Timeframe: before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment
3
Dual-task cost in cognition (Accuracy)
Timeframe: before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment