NCT06608316 Intermittent Theta-burst Stimulation for Mild Cognitive Impairment
| NCT ID | NCT06608316 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hong Kong Polytechnic University |
| Condition | Mild Cognitive Impairment (MCI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 66 participants in total. It began in 2024-11-01 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Frequently Asked Questions
Who can join the NCT06608316 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Mild Cognitive Impairment (MCI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06608316 currently recruiting?
Yes, NCT06608316 is actively recruiting participants. Visit ClinicalTrials.gov or contact The Hong Kong Polytechnic University to inquire about joining.
Where is the NCT06608316 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong, Hong Kong, Hong Kong.
Who is sponsoring the NCT06608316 clinical trial?
NCT06608316 is sponsored by The Hong Kong Polytechnic University. The trial plans to enroll 66 participants.