Mild Cognitive ImpairmentNCT06407141
The Effect of TPS on Cognitive Functions in Older Adults With MCI
A study testing transcranial pulse stimulation in people with Mild Cognitive Impairment, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The goal of this randomized controlled trial is to learn if Transcranial Pulse Stimulation (TPS) can improve cognitive functions in older adults with mild cognitive impairment (MCI). The study will also assess the safety of TPS. Read more about this study
- Who is it for?
- Ages 50 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- transcranial pulse stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Oct 2024to 31 Aug 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 50 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community-dwelling older adults aged 55 and above
- Diagnosed with Mild Cognitive Impairment (MCI), classified based on:
- Subjective reporting of memory deficits A score of 19-24 on the Hong Kong version of the Montreal Cognitive Assessment (HK-MoCA) A score greater than 2 standard deviations on the Lawton Instrumental Activities of Daily Living (IADL) scale A score of 1 point or less on the AD8 questionnaire Right-handedness Ability to cooperate with assessment and intervention, without significant communicative impairments Absence of depression or anxiety, scoring less than 8 on both the Hamilton Depression Scale (HAM-D) and the Hamilton Anxiety Rating Scale (HAM-A)
Who cannot join
- Current or history of dementia or other psychiatric diseases Score greater than or equal to 5 on the Hachinski Ischemic Scale (HIS) for identifying possible vascular-related causes Current or history of alcohol or drug abuse On medication within the last 2 weeks that may affect cognitive functions Report having any present neurological or psychiatric condition besides MCI Report having hemophilia, other blood clotting disorders, or medication that may cause these conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Transcranial Pulse Stimulation on Cognitive Functions in Older Adults With Mild Cognitive Impairment: A Randomized Controlled Trial
The goal of this randomized controlled trial is to learn if Transcranial Pulse Stimulation (TPS) can improve cognitive functions in older adults with mild cognitive impairment (MCI). The study will also assess the safety of TPS. The main questions it aims to answer is:
Does TPS improve cognitive functions such as global cognition, attention, memory, and executive function?
Read more
Researchers will compare TPS to a sham control to evaluate the efficacy and safety of TPS in improving cognitive functions in older adults with MCI.
Participants will:
Be randomly assigned to receive either TPS or a sham intervention Undergo 6 sessions of TPS or sham intervention over a 2-week period Visit the clinic for cognitive assessments at 4 different time points (baseline, immediately post-intervention, 1-month follow-up, and 3-month follow-up) Complete questionnaires and undergo standardized neurocognitive tests, and/or MRI scans, and/or EEG assessments
The study aims to provide insights into the potential therapeutic role of TPS in enhancing cognitive functions among older adults with mild cognitive impairment.
- Conditions
- Mild Cognitive Impairment
- Being tested
- transcranial pulse stimulation, Sham TMS
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial pulse stimulationBehavioural
Participants in the experimental arm will receive six sessions of Transcranial Pulse Stimulation (TPS) over a two-week period, using the NEUROLITH® TPS system (Storz Medical AG, Switzerland). Each session will involve delivering 6,000 ultrasound pulses at an energy level of 0.2-0.25 mJ/mm² and a frequency of 4-5 Hz, targeting specified brain regions based on MRI navigation.
Sham TMSBehavioural
Participants in the sham control group will undergo six sessions over a two-week period, utilizing the same NEUROLITH® TPS system (Storz Medical AG, Switzerland) as used in the experimental group. The key difference lies in the standoff device attached to the handpiece: while the experimental arm uses a standoff filled with silicone oil to transmit ultrasound pulses, the sham group\'s standoff is filled with air. This design ensures that the sham device replicates the appearance, feel, and sound of the active treatment without transmitting any therapeutic pulses, effectively maintaining the blinding aspect of the study.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Not described Receives: Behavioral: transcranial pulse stimulation |
| Sham Control Arm | Sham comparator | Not described Receives: Behavioral: Sham TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Global Cognitive Function
Change in global cognitive function scores from baseline, as measured by the Hong Kong version of the Montreal Cognitive Assessment (HK-MoCA). The HK-MoCA assesses various cognitive domains, including attention, memory, language, visuospatial skills, and executive functions. Scores on the HK-MoCA range from 0 to 30, with higher scores indicating better cognitive function.
Measured: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Improvement in Auditory Attention
Change in auditory attention scores from baseline, as measured by the Auditory Attention Span (AAS) test. This test assesses participants\' ability to maintain focus on auditory stimuli and recall sequences of numbers or words. Higher scores indicate better auditory attention performance.
Measured: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Improvement in Visual Attention
Change in visual attention scores from baseline, as measured by the Visual Attention Span (VAS) test. The VAS test assesses the ability to maintain and recall visual stimuli. Higher scores reflect better visual attention.
Measured: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Improvement in Sustained Attention
Change in sustained attention scores from baseline, as measured by the Continuous Performance Test (CPT). This test evaluates sustained attention and response control, with higher scores indicating improved sustained attention over time.
Measured: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Improvement in Visual-Spatial Judgment
Change in visual-spatial judgment scores from baseline, as measured by the Vision Space Judgment (VSJ) test. This test evaluates the ability to judge spatial relationships between objects, with higher scores indicating improved visual-spatial judgment.
Measured: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Improvement in Working Memory
Change in working memory scores from baseline, as measured by the Math Problems (MP) task. This test evaluates the ability to store and manipulate information related to calculations in working memory. Higher scores indicate better working memory performance.
Measured: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Improvement in Working Memory (Math)
Change in working memory scores from baseline, as measured by the Math Problems (MP) task. This test evaluates the ability to store and manipulate information related to calculations in working memory. Higher scores indicate better working memory performance.
Measured: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Improvement in Working Memory (General)
Change in working memory scores from baseline, as measured by the Working Memory (WM) task. This test evaluates participants\' ability to retain and manipulate verbal and non-verbal information. Higher scores indicate better working memory performance.
Measured: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Improvement in Verbal Memory
Change in verbal memory scores from baseline, as measured by the Verbal Memory List Learning (VMLL) task. This task assesses the ability to encode, store, and retrieve verbal information. Higher scores indicate improved verbal memory.
Measured: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Improvement in Processing Speed
Change in processing speed scores from baseline, as measured by the Symbol Digit Modality Test (SDMT). This test assesses the speed of processing visual information and converting it into a motor response. Higher scores indicate better processing speed.
Measured: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Improvement in Language - Vocabulary
Change in vocabulary scores from baseline, as measured by the Receptive Vocabulary (RV) task. This test evaluates participants\' understanding and recognition of spoken words. Higher scores indicate improved language and vocabulary skills.
Measured: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Improvement in Executive Functioning - Fluency
Change in executive functioning scores from baseline, as measured by the Figural Fluency Test (FFT). This test assesses participants\' ability to generate novel responses and plan effectively. Higher scores indicate better executive functioning.
Measured: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Improvement in Depressive Symptoms
Change in depressive symptoms from baseline, as measured by the Hamilton Depression Rating Scale (HAM-D). Higher scores indicate more severe depressive symptoms, while lower scores indicate improvement.
Measured: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Improvement in Anxiety Symptoms
Change in anxiety symptoms from baseline, as measured by the Hamilton Anxiety Rating Scale (HAM-A). Higher scores indicate more severe anxiety symptoms, while lower scores indicate improvement.
Measured: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Improvement in Instrumental Activities of Daily Living
Change in functional independence from baseline, as measured by the Hong Kong Lawton Instrumental Activities of Daily Living (IADL) Scale. Higher scores indicate greater independence in daily living activities.
Measured: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Improvement in Quality of Life
Change in quality of life scores from baseline, as measured by the Quality of Life in Alzheimer\'s Disease (QoL-AD) scale. Higher scores indicate better perceived quality of life.
Measured: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Secondary outcomes (1)
Adverse Reactions
Monitoring of adverse reactions using a self-reported questionnaire after each TPS session. The questionnaire assesses potential side effects such as headaches, dizziness, or other discomforts.
Measured: Immediately after each TPS session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start2 Oct 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LEE LEUNG PONG, The University of Hong Kong
- Investigators
- Leung Pong Lee, MOT MPsyMed, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407141
- Sponsor's protocol ID
- PSYTPS
- Status last verified
- Oct 2024
- First submitted
- 6 May 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcranial Pulse Stimulation on Cognitive Functions in Older Adults With Mild Cognitive Impairment: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06407141
- Acronym / sponsor ID
- PSYTPS
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 9 May 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 goal of this randomized controlled trial is to learn if Transcranial Pulse Stimulation (TPS) can improve cognitive functions in older adults with mild cognitive impairment (MCI). The study will also assess the safety of TPS. The main questions it aims to answer is:
Does TPS improve cognitive functions such as global cognition, attention, memory, and executive function?
Researchers will compare TPS to a sham control to evaluate the efficacy and safety of TPS in improving cognitive functions in older adults with MCI.
Participants will:
Be randomly assigned to receive either TPS or a sham intervention Undergo 6 sessions of TPS or sham intervention over a 2-week period Visit the clinic for cognitive assessments at 4 different time points (baseline, immediately post-intervention, 1-month follow-up, and 3-month follow-up) Complete questionnaires and undergo standardized neurocognitive tests, and/or MRI scans, and/or EEG assessments
The study aims to provide insights into the potential therapeutic role of TPS in enhancing cognitive functions among older adults with mild cognitive impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Behavioral: transcranial pulse stimulation |
| Sham Control Arm | Sham comparator | Behavioral: Sham TMS |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Community-dwelling older adults aged 55 and above
- Subjective reporting of memory deficits A score of 19-24 on the Hong Kong version of the Montreal Cognitive Assessment (HK-MoCA) A score greater than 2 standard deviations on the Lawton Instrumental Activities of Daily Living (IADL) scale A score of 1 point or less on the AD8 questionnaire Right-handedness Ability to cooperate with assessment and intervention, without significant communicative impairments Absence of depression or anxiety, scoring less than 8 on both the Hamilton Depression Scale (HAM-D) and the Hamilton Anxiety Rating Scale (HAM-A)
Key exclusion criteria (1 listed)
- Current or history of dementia or other psychiatric diseases Score greater than or equal to 5 on the Hachinski Ischemic Scale (HIS) for identifying possible vascular-related causes Current or history of alcohol or drug abuse On medication within the last 2 weeks that may affect cognitive functions Report having any present neurological or psychiatric condition besides MCI Report having hemophilia, other blood clotting disorders, or medication that may cause these conditions
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 |
|---|---|---|
| transcranial pulse stimulationParticipants in the experimental arm will receive six sessions of Transcranial Pulse Stimulation (TPS) over a two-week period, using the NEUROLITH® TPS system (Storz Medical AG, Switzerland). Each session will involve delivering 6,000 ultrasound pulses at an energy level of 0.2-0.25 mJ/mm² and a frequency of 4-5 Hz, targeting specified brain regions based on MRI navigation. | Behavioural | Experimental Arm |
| Sham TMSParticipants in the sham control group will undergo six sessions over a two-week period, utilizing the same NEUROLITH® TPS system (Storz Medical AG, Switzerland) as used in the experimental group. The key difference lies in the standoff device attached to the handpiece: while the experimental arm uses a standoff filled with silicone oil to transmit ultrasound pulses, the sham group\'s standoff is filled with air. This design ensures that the sham device replicates the appearance, feel, and sound of the active treatment without transmitting any therapeutic pulses, effectively maintaining the blinding aspect of the study. | Behavioural | Sham Control Arm |
Primary outcome
Improvement in Global Cognitive Function
Time frame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Change in global cognitive function scores from baseline, as measured by the Hong Kong version of the Montreal Cognitive Assessment (HK-MoCA). The HK-MoCA assesses various cognitive domains, including attention, memory, language, visuospatial skills, and executive functions. Scores on the HK-MoCA range from 0 to 30, with higher scores indicating better cognitive function.
Improvement in Auditory Attention
Time frame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Change in auditory attention scores from baseline, as measured by the Auditory Attention Span (AAS) test. This test assesses participants\' ability to maintain focus on auditory stimuli and recall sequences of numbers or words. Higher scores indicate better auditory attention performance.
Improvement in Visual Attention
Time frame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Change in visual attention scores from baseline, as measured by the Visual Attention Span (VAS) test. The VAS test assesses the ability to maintain and recall visual stimuli. Higher scores reflect better visual attention.
Improvement in Sustained Attention
Time frame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Change in sustained attention scores from baseline, as measured by the Continuous Performance Test (CPT). This test evaluates sustained attention and response control, with higher scores indicating improved sustained attention over time.
Improvement in Visual-Spatial Judgment
Time frame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Change in visual-spatial judgment scores from baseline, as measured by the Vision Space Judgment (VSJ) test. This test evaluates the ability to judge spatial relationships between objects, with higher scores indicating improved visual-spatial judgment.
Improvement in Working Memory
Time frame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Change in working memory scores from baseline, as measured by the Math Problems (MP) task. This test evaluates the ability to store and manipulate information related to calculations in working memory. Higher scores indicate better working memory performance.
Improvement in Working Memory (Math)
Time frame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Change in working memory scores from baseline, as measured by the Math Problems (MP) task. This test evaluates the ability to store and manipulate information related to calculations in working memory. Higher scores indicate better working memory performance.
Improvement in Working Memory (General)
Time frame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Change in working memory scores from baseline, as measured by the Working Memory (WM) task. This test evaluates participants\' ability to retain and manipulate verbal and non-verbal information. Higher scores indicate better working memory performance.
Improvement in Verbal Memory
Time frame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Change in verbal memory scores from baseline, as measured by the Verbal Memory List Learning (VMLL) task. This task assesses the ability to encode, store, and retrieve verbal information. Higher scores indicate improved verbal memory.
Improvement in Processing Speed
Time frame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Change in processing speed scores from baseline, as measured by the Symbol Digit Modality Test (SDMT). This test assesses the speed of processing visual information and converting it into a motor response. Higher scores indicate better processing speed.
Improvement in Language - Vocabulary
Time frame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Change in vocabulary scores from baseline, as measured by the Receptive Vocabulary (RV) task. This test evaluates participants\' understanding and recognition of spoken words. Higher scores indicate improved language and vocabulary skills.
Improvement in Executive Functioning - Fluency
Time frame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Change in executive functioning scores from baseline, as measured by the Figural Fluency Test (FFT). This test assesses participants\' ability to generate novel responses and plan effectively. Higher scores indicate better executive functioning.
Improvement in Depressive Symptoms
Time frame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Change in depressive symptoms from baseline, as measured by the Hamilton Depression Rating Scale (HAM-D). Higher scores indicate more severe depressive symptoms, while lower scores indicate improvement.
Improvement in Anxiety Symptoms
Time frame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Change in anxiety symptoms from baseline, as measured by the Hamilton Anxiety Rating Scale (HAM-A). Higher scores indicate more severe anxiety symptoms, while lower scores indicate improvement.
Improvement in Instrumental Activities of Daily Living
Time frame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Change in functional independence from baseline, as measured by the Hong Kong Lawton Instrumental Activities of Daily Living (IADL) Scale. Higher scores indicate greater independence in daily living activities.
Improvement in Quality of Life
Time frame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Change in quality of life scores from baseline, as measured by the Quality of Life in Alzheimer\'s Disease (QoL-AD) scale. Higher scores indicate better perceived quality of life.
1 secondary outcome
Adverse Reactions
Time frame: Immediately after each TPS session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Leung Pong Lee, MOT MPsyMed principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial pulse stimulation in people with Mild Cognitive Impairment, run by The University of Hong Kong 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Oct 2024. 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?
Results are not available in the source record.
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?
Improvement in Global Cognitive Function (time frame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up). The study lists 16 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 10 Oct 2024.