NCT05331560

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

Status unknown NA Last updated 15 April 2022

What this trial tests

NA trial testing Transcranial Pulse Stimulation (TPS) in Mild Neurocognitive Disorder in 20 participants. Status unknown.

Timeline

20 January 2020

Primary endpoint
20 January 2023

30 July 2024

Quick facts

Lead sponsor	The University of Hong Kong
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	20 January 2020
Primary completion	20 January 2023
Estimated completion	30 July 2024
Sites	1 location across Hong Kong

Drugs / interventions tested

• Transcranial Pulse Stimulation (TPS)

Conditions studied

• Mild Neurocognitive Disorder — all drugs for Mild Neurocognitive Disorder →

Sponsor

The University of Hong Kong

Who can join

60 and older, any sex, with Mild Neurocognitive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current state of clinical ultrasound neuromodulation.
   Matt E, Radjenovic S, Mitterwallner M, Beisteiner R. · · 2024 · cited 27× · PMID 38962179 · DOI 10.3389/fnins.2024.1420255
2. Transcranial pulse stimulation in the treatment of mild neurocognitive disorders.
   Fong TKH, Cheung T, Ngan STJ, Tong K, et al · · 2023 · cited 18× · PMID 37607114 · DOI 10.1002/acn3.51882
3. Enhanced Cognition and Modulation of Brain Connectivity in Mild Neurocognitive Disorder: The Promise of Transcranial Pulse Stimulation.
   Lo HK, Fong TK, Cheung T, Ngan SJ, et al · · 2024 · cited 8× · PMID 39335594 · DOI 10.3390/biomedicines12092081