Effect of Multisite High-definition Transcranial Direct Current Stimulation Targeting Sensorimotor Network

NCT06648954 | Recruiting

• 1 other identifier: 2018.661b
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Transcranial direct current stimulation (tDCS) has been applied to facilitate cortical excitability in stroke populations, as increasing evidence suggests that clinical recovery from stroke is attributed to neuroplastic reorganization. However, recovery from stroke following this kind of non-invasive neuromodulation remains divergent across stroke patients due to variations in their etiologies, lesion profiles and post-stroke duration. A novel multisite high definition tDCS (HD-tDCS) in healthy people showed that such network-targeted stimulation could enhance motor excitability beyond conventional stimulation which targeting only one region. The electrode placements could be determined by the montage optimization, which targets individual motor network activation navigated by task-based fMRI using computation algorithms. By targeting motor network, the new multisite electrode montage may provide a potential to facilitate better cortical activation than conventional tDCS montage.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Resting-state functional connectivity

  Functional magnetic resonance imaging for collecting BOLD signals during resting-state.

  before and immediately after stimulation

Secondary Outcomes (2)

• Fugl-Meyer Assessment

  before experiment

• task-based brain activation

  before and immediately after stimulation

Study Arms (3)

Multisite HD-tDCS group

EXPERIMENTAL

Device: Constant current will be applied for 20min and the electrodes will be placed over the target area

Device: multisite HD-tDCS

Sham stimulation group

SHAM COMPARATOR

The stimulator will be applied for 20 minutes with only 30s ramp-up and ramp-down stimulation delivered. The patients will feel the initial itching sensation at the beginning in order to evaluate the placebo effect.

Device: Sham stimulation

Conventional tDCS Group

ACTIVE COMPARATOR

Constant current (2mA) will be applied for 20min and the anode will be placed over the standard C3/C4 position.

Device: Conventional tDCS

Interventions

multisite HD-tDCS DEVICE

5-8 MRI compatible electrodes (2 cm diameter) will be placed based on the neuroimaging and computation modelling. The electrodes will be placed inside MRI compatible sponges and affixed to the head using a device matched cap which will be filled with saline to have good contact with the scalp.

Multisite HD-tDCS group

Conventional tDCS DEVICE

A pair of 25 cm2 rubber electrodes enclosed in saline-soaked sponges and affixed to the head with rubber bands.

Conventional tDCS Group

Sham stimulation DEVICE

5-8 MRI compatible electrodes (2 cm diameter) will be placed based on the neuroimaging and computation modelling. The electrodes will be placed inside MRI compatible sponges and affixed to the head using a device matched cap which will be filled with saline to have good contact with the scalp.

Sham stimulation group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• first-ever stroke, the duration after stroke exceeds 12 months;
• mild to moderate upper extremity motor function deficit, determined by the Fugl-meyer assessment of upper extremity (FMAUE) scores between 15 and 53;
• could voluntarily perform grasping hand movement.
• sufficient cognitive function to follow the assessment and experiment instructions.

You may not qualify if:

• history of epilepsy, or any other contradictions of brain stimulation and MRI scanning;
• severe joint contracture of elbow or shoulder, or pain induced by any other neurological, neuromuscular, and orthopedic diseases.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Biomedical Engineering, The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Raymond Kai-yu Tong, PhD

  Department of Biomedical Engineering, CUHK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raymond Kai-yu Tong, PhD

CONTACT

+852 3943 8454; kytong@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 15, 2024
• First Posted: October 18, 2024
• Study Start: August 13, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

HK (1)