Mild Cognitive Impairment (MCI)NCT06608316
Intermittent Theta-burst Stimulation for Mild Cognitive Impairment
A study testing Intermittent Theta Burst Stimulation in people with Mild Cognitive Impairment (MCI), run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- Intermittent Theta Burst Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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 join
- 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;
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- Unstable vital signs or organ failure;
- Neuropsychiatric comorbidity or affective disorder that could affect the test results;
- Patients with dementia.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The Hong Kong Polytechnic University
Hong Kong, Hong Kong, 000000
About this study
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
The objectives of this study are to:
- 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.
- 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.
- 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.
Read the detailed description
Mild cognitive impairment (MCI) is a syndrome characterized by cognitive decline that is greater than expected with normal aging; however, it is not severe enough to meet dementia criteria. Accordingly, MCI is considered a transitional state between normal aging and dementia, with a high risk of progression to Alzheimer's disease (AD). In MCI, memory and other cognitive domains such as executive function and visuospatial skills are typically affected. Furthermore, people with MCI have impaired dual-task walking function, decreased balance, and an increased risk of falls compared to cognitively normal older adults, thus affecting the ability to perform daily activities. Moreover, sleep disturbances, such as reduced efficiency and disruptions, are common in MCI, which exacerbates cognitive decline and accelerates the progression to dementia.
Non-invasive brain stimulation (NIBS) techniques have shown potential for enhancing both cognitive and functional outcomes in neuropsychiatric diseases. Transcranial magnetic stimulation (TMS) is the most common form of NIBS, which modulates cortical excitability and neuroplasticity by inducing electromagnetic pulses in targeted brain regions. TMS can be delivered in various forms based on frequency and intervals. Intermittent theta burst stimulation (iTBS) is a type of patterned TMS that mimics endogenous theta rhythms. It has shown cognitive benefits in healthy populations as well as those with AD, depression, and other conditions, but evidence regarding its efficacy in MCI is limited.
While interventions like dual-task training and non-invasive brain stimulation (e.g., tDCS) have shown promise in mitigating dual-task coordination impairments, research specifically focusing on the impact of iTBS on dual-task walking abilities in MCI patients remains scarce. Further research is needed to explore the potential of iTBS to improve dual-task walking ability, balance, and fall prevention in MCI populations.
Although the dorsolateral prefrontal cortex (DLPFC) is often targeted with NIBS due to its role in executive functions, comparisons of bilateral versus unilateral left DLPFC stimulation have not been conducted in MCI. Overall, there is a lack of empirical evidence supporting the use of iTBS protocols to improve cognition and functional activities in MCI. Elucidating the neurophysiological mechanisms underlying NIBS techniques like iTBS remains imperative.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- Intermittent Theta Burst Stimulation
- Keywords
- Intermittent Theta Burst Stimulation (iTBS), Dorsolateral Prefrontal Cortex (DLPFC), dual task walking, cognitive function
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Theta Burst StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Left DLPFC stimulation group | Experimental | 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. Receives: Device: Intermittent Theta Burst Stimulation |
| Bilateral DLPFC stimulation group | Experimental | 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. Receives: Device: Intermittent Theta Burst Stimulation |
| Sham stimulation group | Sham comparator | Sham coil stimulates the left and right DLPFC. Receives: Device: Intermittent Theta Burst Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual-task cost in cognition (Reaction time)
Reaction time will be measured during dual-task conditions
Measured: before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment
Dual-task cost in gait (gait speed)
Gait speed under dual-task condition will be recorded
Measured: before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment
Dual-task cost in cognition (Accuracy)
Accuracy will be measured during dual-task conditions
Measured: before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment
Secondary outcomes (6)
Blood oxygenation level changes of the brain
Blood oxygenation level changes will be measured using Functional Near-Infrared Spectroscopy during dual-task conditions
Measured: before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment
Dual-task gait performance 1 (gait variability)
Gait variability will be measured during dual-task walking
Measured: before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment
Dual-task gait performance 2 (stride length)
Stride length will be measured during dual-task walking
Measured: before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment
Dual-task gait performance 3 (walking distance)
Walking distance will be measured during dual-task walking
Measured: before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment
Dual-task gait performance 4 (gait cadence)
Gait cadence will be measured during dual-task walking
Measured: before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment
Dual-task gait performance 5 (trunk stability)
Trunk stability will be measured during dual-task walking
Measured: before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start1 Nov 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment: After stratification according to gender and age, the participants will be randomly allocated to one of three groups: (1) Left DLPFC stimulation group, (2) Bilateral DLPFC stimulation group, and (3) Sham stimulation group, using a 1:1:1 allocation ratio.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608316
- Sponsor's protocol ID
- Marco_PANG_2024_July
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study data can be provided via contacting the Principal Investigator
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06608316
- Acronym / sponsor ID
- Marco_PANG_2024_July
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- Intermittent Theta Burst Stimulation (iTBS), Dorsolateral Prefrontal Cortex (DLPFC), dual task walking, cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to:
- 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.
- 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.
- 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.
Detailed description
Mild cognitive impairment (MCI) is a syndrome characterized by cognitive decline that is greater than expected with normal aging; however, it is not severe enough to meet dementia criteria. Accordingly, MCI is considered a transitional state between normal aging and dementia, with a high risk of progression to Alzheimer's disease (AD). In MCI, memory and other cognitive domains such as executive function and visuospatial skills are typically affected. Furthermore, people with MCI have impaired dual-task walking function, decreased balance, and an increased risk of falls compared to cognitively normal older adults, thus affecting the ability to perform daily activities. Moreover, sleep disturbances, such as reduced efficiency and disruptions, are common in MCI, which exacerbates cognitive decline and accelerates the progression to dementia.
Non-invasive brain stimulation (NIBS) techniques have shown potential for enhancing both cognitive and functional outcomes in neuropsychiatric diseases. Transcranial magnetic stimulation (TMS) is the most common form of NIBS, which modulates cortical excitability and neuroplasticity by inducing electromagnetic pulses in targeted brain regions. TMS can be delivered in various forms based on frequency and intervals. Intermittent theta burst stimulation (iTBS) is a type of patterned TMS that mimics endogenous theta rhythms. It has shown cognitive benefits in healthy populations as well as those with AD, depression, and other conditions, but evidence regarding its efficacy in MCI is limited.
While interventions like dual-task training and non-invasive brain stimulation (e.g., tDCS) have shown promise in mitigating dual-task coordination impairments, research specifically focusing on the impact of iTBS on dual-task walking abilities in MCI patients remains scarce. Further research is needed to explore the potential of iTBS to improve dual-task walking ability, balance, and fall prevention in MCI populations.
Although the dorsolateral prefrontal cortex (DLPFC) is often targeted with NIBS due to its role in executive functions, comparisons of bilateral versus unilateral left DLPFC stimulation have not been conducted in MCI. Overall, there is a lack of empirical evidence supporting the use of iTBS protocols to improve cognition and functional activities in MCI. Elucidating the neurophysiological mechanisms underlying NIBS techniques like iTBS remains imperative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel Assignment: After stratification according to gender and age, the participants will be randomly allocated to one of three groups: (1) Left DLPFC stimulation group, (2) Bilateral DLPFC stimulation group, and (3) Sham stimulation group, using a 1:1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Left DLPFC stimulation group | Experimental | Device: Intermittent Theta Burst Stimulation80% 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. |
| Bilateral DLPFC stimulation group | Experimental | Device: Intermittent Theta Burst Stimulation80% 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. |
| Sham stimulation group | Sham comparator | Device: Intermittent Theta Burst StimulationSham coil stimulates the left and right DLPFC. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent Theta Burst StimulationA 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. | Device | Bilateral DLPFC stimulation group, Left DLPFC stimulation group, Sham stimulation group |
Primary outcome
Dual-task cost in cognition (Reaction time)
Time frame: before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment
Reaction time will be measured during dual-task conditions
Dual-task cost in gait (gait speed)
Time frame: before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment
Gait speed under dual-task condition will be recorded
Dual-task cost in cognition (Accuracy)
Time frame: before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment
Accuracy will be measured during dual-task conditions
6 secondary outcomes
Blood oxygenation level changes of the brain
Time frame: before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment
Dual-task gait performance 1 (gait variability)
Time frame: before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment
Dual-task gait performance 2 (stride length)
Time frame: before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment
Dual-task gait performance 3 (walking distance)
Time frame: before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment
Dual-task gait performance 4 (gait cadence)
Time frame: before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment
Dual-task gait performance 5 (trunk stability)
Time frame: before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Yes. The study data can be provided via contacting the Principal Investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Theta Burst Stimulation in people with Mild Cognitive Impairment (MCI), run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual-task cost in cognition (Reaction time) (time frame: before the initiation of treatment, after 3 weeks of treatment, 4 weeks after termination of the treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.