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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06407141
• Other study ID #: PSYTPS
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 8, 2024
• Est. completion date: August 31, 2025

Study information

• Verified date: May 2024
• Source: The University of Hong Kong
• Contact: Leung Pong Lee, BSocSc (Hons 1) MOT MPsyMed
• Phone: 64969335
• Email: dinollp[@]connect.hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

Inclusion Criteria:

• Community-dwelling older adults aged 55 and above; and diagnosed with MCI, classified based on subjective reporting of memory deficits, a score of 19-24 on the Hong Kong version of the MoCA (HK-MoCA), a score greater than 2 standard deviations on the Lawton Instrumental Activities of Daily Living (IADL) scale, and 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:

• (1) Current or history of dementia or other psychiatric diseases (2) Score greater than or equal to 5 on the Hachinski Ischemic Scale (HIS) 35 for identifying possible vascular-related causes.

(3) Current or history of alcohol or drug abuse (4) On medication within the last 2 weeks that may affect cognitive functions (5) Report having any present neurological or psychiatric condition besides MCI (6) Report having hemophilia, other blood clotting disorders, or medication that may cause these conditions.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline, immediately post-intervention, 1-month follow-up, 3-month follow-up