The Effect of TPS on Cognitive Functions in Older Adults With MCI

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted9 May 2024
2. Study start2 Oct 2024
3. Primary completion30 Jun 2025 (estimated)
4. 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.