Using intermittent theta-burst stimulation to improve cognitive and physical functions in older adults with 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
This study is testing if a new brain stimulation technique can help older adults with mild cognitive impairment think better and move more easily.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | The Hong Kong Polytechnic University Academic / other |
| Locations | 2 sites (Hong Kong, Hong Kong and 1 other locations) |
| Trial ID | NCT06608316 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of intermittent theta-burst stimulation (iTBS) on cognitive and physical functions in older adults with mild cognitive impairment (MCI). It compares the efficacy of iTBS targeting the left dorsolateral prefrontal cortex versus bilateral stimulation, aiming to identify differences in therapeutic outcomes. Additionally, the study investigates the neurophysiological mechanisms behind improvements in cognitive functions and dual-task walking abilities using fNIRS neuroimaging. The goal is to enhance daily functioning and reduce the risk of falls in this population.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 65 and above with mild cognitive impairment who can walk independently and have intact daily functioning.
Not a fit: Patients with cognitive dysfunction due to neurological diseases or those with severe physical illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve cognitive and physical functions in patients with mild cognitive impairment, enhancing their quality of life.
How similar studies have performed: Previous studies have shown promising results with non-invasive brain stimulation techniques like TMS, suggesting potential for success with this novel application of iTBS.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hong Kong, Hong Kong and 1 other locations
- The Hong Kong Polytechnic University — Hong Kong, Hong Kong, Hong Kong (Not_yet_recruiting)
- The Hong Kong Polytechnic University — Hong Kong, Hong Kong, Hong Kong (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.