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

Официальное название

The Effect of Transcranial Pulse Stimulation on Cognitive Functions in Older Adults With Mild Cognitive Impairment: A Randomized Controlled Trial

Обзор

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.

Вмешательства

• Поведенческое transcranial pulse stimulation
  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.
• Поведенческое Sham TMS
  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 s

Первичные конечные точки

• Improvement in Global Cognitive Function [Срок оценки: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up]
• Improvement in Auditory Attention [Срок оценки: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up]
• Improvement in Visual Attention [Срок оценки: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up]
• Improvement in Sustained Attention [Срок оценки: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up]
• Improvement in Visual-Spatial Judgment [Срок оценки: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up]
• Improvement in Working Memory [Срок оценки: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up]
• Improvement in Working Memory (Math) [Срок оценки: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up]
• Improvement in Working Memory (General) [Срок оценки: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up]
• Improvement in Verbal Memory [Срок оценки: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up]
• Improvement in Processing Speed [Срок оценки: Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up]

Вторичные конечные точки (1)

• Adverse Reactions [Срок оценки: Immediately after each TPS session]

Критерии участия

Eligibility Criteria

Критерии включения

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)

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• Department of Psychology — Гонконг

Идентификаторы

NCT: NCT06407141 · PSYTPS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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