Intermittent Theta-burst Stimulation for Mild Cognitive Impairment
Key facts
- Who runs it
- The Hong Kong Polytechnic University
- Where
- Hong Kong1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 72 people enrolled
- Started
- 1 Nov 2024
- Ended
- 31 Dec 2025
- Type of study
- Interventional, 3 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- Intermittent Theta Burst Stimulation
- Record updated
- 17 September 2026
Who can take part
- Age
- 65 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- Currently taking antidepressants or psychostimulants
- 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
- Unstable vital signs or organ failure
- Neuropsychiatric comorbidity or affective disorder that could affect the test results
- Patients with dementia
- Identified with contraindications in the rTMS screening questionnaire
- Significant damage to the left frontal lobe cortex
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The objectives of this study are to:
Read full original descriptionShow less
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.
The 3 groups in the trial
- Left DLPFC stimulation groupTreatment being tested
80% resting motor threshold (RMT) iTBS stimulated the left DLPFC 4 sessions per day at 15 min intervals (3min per session), 3 days per week for 3 weeks. Sham stimulation of the right DLPFC will be performed.
Treatment: Intermittent Theta Burst Stimulation
- Bilateral DLPFC stimulation groupTreatment being tested
80% RMT iTBS stimulated the bilateral DLPFC 4 sessions per day at 15 min intervals (2 sessions on the left, 2 sessions on the right, 3 min per session), 3 days per week for 3 weeks.
Treatment: Intermittent Theta Burst Stimulation
- Sham stimulation groupSham treatment, for comparison
Sham coil stimulates the left and right DLPFC.
Treatment: Intermittent Theta Burst Stimulation
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Optimizing Intermittent Theta-burst Stimulation for Enhancing Dual-Task Walking, Cognitive, and Physical Function in Mild Cognitive Impairment: A Randomized Double-Blind Controlled Trial
- Record updated
- 17 September 2026