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

NCT05331560 | Unknown DMC

• 1 other identifier: UW20-024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Transcranial pulse stimulation; mild neurocognitive disorder; open-label; self-controlled trial

Outcome Measures

Primary Outcomes (1)

• Change in Global Cognition

  Global cognition measured using the Hong Kong Chinese version of the Montreal Cognitive Assessment (HK-MoCA) is our primary outcome. The total score ranges from 0-30 with higher scores indicating better cognition.

  Baseline, 12-week Treatment-As-Usual, Immediate after 2-week TPS Treatment, 12-week Follow-up

Secondary Outcomes (11)

• Changes in Verbal Fluency

  Baseline, 12-week Treatment-As-Usual, Immediate after 2-week TPS Treatment, 12-week Follow-up

• Change in Working Memory

  Baseline, 12-week Treatment-As-Usual, Immediate after 2-week TPS Treatment, 12-week Follow-up

• Change in Executive Functioning

  Baseline, 12-week Treatment-As-Usual, Immediate after 2-week TPS Treatment, 12-week Follow-up

• Change in Attention

  Baseline, 12-week Treatment-As-Usual, Immediate after 2-week TPS Treatment, 12-week Follow-up

• Change in Depressive Symptoms

  Baseline, 12-week Treatment-As-Usual, Immediate after 2-week TPS Treatment, 12-week Follow-up

Study Arms (1)

Treatment Group

EXPERIMENTAL

A 2-week intervention TPS intervention will result in a significant improvement in the Montreal Cognitive Assessment (HK-MoCA; Hong Kong Chinese version), which will be maintained for 12 weeks.

Device: Transcranial Pulse Stimulation (TPS)

Interventions

Transcranial Pulse Stimulation (TPS) DEVICE

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).

Treatment Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 60 years of age or above
• \. Chinese ethnicity
• \. Mild neurocognitive disorder (NCD) meeting the 5th Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria
• \. At least 3 months of stable anti-dementia therapy prior to enrolment (unchanged medication, if receiving)
• \. Written informed consent

You may not qualify if:

• \. A HK-MoCA score below the second percentile according to the subject's age and education level
• \. Alcohol or substance dependence
• \. Concomitant unstable major medical conditions or major neurological conditions such as brain tumour, brain aneurysm
• \. Haemophilia or other blood clotting disorders or thrombosis
• \. Significant communicative impairments
• \. Participants with any metal implant in brain or treated area of the head

Sponsors & Collaborators

• The University of Hong Kong: lead
• Storz Medical AG: collaborator

Study Sites (1)

The Hong Kong Jockey Club Building for Interdisciplinary Research

Hong Kong, Hong Kong

RECRUITING

Related Publications (14)

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  PMID: 29380485 BACKGROUND

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• Spagnolo PA, Wang H, Srivanitchapoom P, Schwandt M, Heilig M, Hallett M. Lack of Target Engagement Following Low-Frequency Deep Transcranial Magnetic Stimulation of the Anterior Insula. Neuromodulation. 2019 Dec;22(8):877-883. doi: 10.1111/ner.12875. Epub 2018 Oct 29.

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MeSH Terms

Conditions

Neurocognitive Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Calvin Pak Wing Cheng, MBBS (HKU)

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Calvin Pak Wing Cheng, MBBS (HKU)

CONTACT

22554486; chengpsy@hku.hk

Tommy Kwan Hin Fong, MPsyMed

CONTACT

64214186; tommykhf@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Since TPS is a new NIBS technology, no studies have been done on older adults with mild NCD, which is a golden period for intervention before the pathology involved the whole brain and leading to irreversible damage. We would like to perform an open-label self-controlled study to assess the effectiveness and tolerability of TPS with neuro-navigation on cognition in older adults with mild NCD.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 15, 2022
• Study Start: January 20, 2020
• Primary Completion: January 20, 2023
• Study Completion: July 30, 2024
• Last Updated: April 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)