Transcranial Pulse Stimulation Open-label Self-controlled Trial For Mild Neurocognitive Disorder

Summary

Background:

A significant proportion of older adults suffered from age-related diseases particularly dementia, also known as major neurocognitive disorder (NCD), which is becoming a worldwide health burden. In principle, Interventions for dementia should have optimal benefits at the earliest preclinical stage yet no evidence has been found to support a particular pharmacological approach in preventing cognitive decline during the stage of mild NCD. Non-invasive brain stimulation (NIBS), on the other hand, is increasingly recognized as a potential alternative to tackle this problem. Typical NIBS include transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS). A new kind of NIBS named Transcranial Pulse stimulation (TPS) is also recently used for treating patients with Alzheimer's disease (AD).TPS is a kind of NIBS that uses repetitive sin ultrashort pulses in the ultrasound frequency range to stimulate the brain, and it can provide better spatial precision and reach deeper brain regions comparing to tDCS and TMS. The mechanism of TPS is to convert the mechanical TPS stimulus into biochemical responses, thus influence some fundamental cell functions. A recent study showed that there is a significant improvement in using TPS in treating AD. However, there has been no study investigating the effect of TPS on older adults with mild NCD.

Objective:

This study is an open-label self-controlled study to assess the effectiveness and tolerability of TPS on cognition in older adults with mild NCD. We hypothesized that a 2-week TPS intervention could significantly improve patient's global cognition which will be maintained for 12 weeks.

Design:

The current study is an open-label self-controlled interventional trial of TPS guided by neuro-navigation using structural MRI. All participants will undergo the treatment as usual (TAU) period as self-controlled for 12 weeks. They will then receive a six-session TPS intervention for 2 weeks with three sessions per week. A 12 weeks post-intervention assessment will then be conducted.

Data Analysis:

Primary outcome and secondary outcomes assessment would be carried out at baseline, after TAU period, immediately after the intervention and 12 weeks after the intervention. The primary outcome will be the change of the Hong Kong Chinese version of the Montreal Cognitive Assessment (HK-MoCA). The secondary outcome includes specific cognitive domains, daily functioning, mood, and apathy. The intention-to-treat analysis would be carried out.

Significance:

The result of the current study would provide further data on the effectiveness and tolerability of TPS as a new treatment in patients with mild NCD.

Conditions

• Mild Neurocognitive Disorder

Interventions

DEVICE

Transcranial Pulse Stimulation (TPS)

A global brain stimulation approach, which homogenously distributes the total energy of 6000 TPS pulses per session over all accessible brain areas. Prefrontal, Temporal and Occipital brain areas were stimulated by ultrashort (3μs) ultrasound pulses with typical energy levels of 0.2-0.25 mJ/mm2 and pulse frequencies of 4-5 Hz (pulses per second).

Sponsors & Collaborators

• Storz Medical AG

  collaborator INDUSTRY

• The University of Hong Kong

  lead OTHER

Principal Investigators

• Calvin Pak Wing Cheng, MBBS (HKU) · The University of Hong Kong

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-20

Primary Completion

2023-01-20

Completion

2024-07-30

Countries

• Hong Kong

Study Locations