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

NCT06407141 | Enrolling By Invitation DMC

• 1 other identifier: PSYTPS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (16)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up

Secondary Outcomes (1)

• Adverse Reactions

  Immediately after each TPS session

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Behavioral: transcranial pulse stimulation

Sham Control Arm

SHAM COMPARATOR

Behavioral: Sham TMS

Interventions

transcranial pulse stimulation BEHAVIORAL

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.

Experimental Arm

Sham TMS BEHAVIORAL

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.

Sham Control Arm

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Department of Psychology

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Leung Pong Lee, MOT MPsyMed

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSocSc Clinical Psychology Student

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: October 2, 2024
• Primary Completion: June 30, 2025
• Study Completion: August 31, 2025
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)