Clinical trial NCT06407141: The Effect of TPS on Cognitive Functions in Older Adults With MCI
Official title: The Effect of Transcranial Pulse Stimulation on Cognitive Functions in Older Adults With Mild Cognitive Impairment: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Primary outcomes:
measure: Improvement in Global Cognitive Function
timeFrame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
measure: Improvement in Auditory Attention
timeFrame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
measure: Improvement in Visual Attention
timeFrame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
measure: Improvement in Sustained Attention
timeFrame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
measure: Improvement in Visual-Spatial Judgment
timeFrame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
measure: Improvement in Working Memory
timeFrame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
measure: Improvement in Working Memory (Math)
timeFrame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
measure: Improvement in Working Memory (General)
timeFrame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
measure: Improvement in Verbal Memory
timeFrame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
measure: Improvement in Processing Speed
timeFrame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
measure: Improvement in Language - Vocabulary
timeFrame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
measure: Improvement in Executive Functioning - Fluency
timeFrame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
measure: Improvement in Depressive Symptoms
timeFrame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
measure: Improvement in Anxiety Symptoms
timeFrame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
measure: Improvement in Instrumental Activities of Daily Living
timeFrame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
measure: Improvement in Quality of Life
timeFrame: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up
Secondary outcomes:
measure: Adverse Reactions
timeFrame: Immediately after each TPS session
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Psychology
Study officials:
affiliation: The University of Hong Kong
name: Leung Pong Lee, MOT MPsyMed
role: PRINCIPAL_INVESTIGATOR
References: