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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-13

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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 durations. In the stroke application of tDCS, most non-invasive brain stimulation studies have mainly focused on the modulation of the primary motor cortex (M1) in motor skill relearning. Previous studies have shown that not only the M1, which is the most important area associated with the motor system, but also other secondary motor areas (e.g., premotor cortex (PM) and supplementary motor area (SMA)) can be influenced by the onset of stroke. In fact, SMA activations and shifts in the M1 are commonly observed in stroke patients. However, brain regions do not operate in isolation, but communicate and interact with other discrete regions through networks. Conventional stimulations of one region (normally the M1 in stroke) have neglected the network impact and the changed motor network composition after stroke, which is often limited in stroke rehabilitation. 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. It showed that the excitability following multisite HD-tDCS was more than double the increase following conventional tDCS.

To consider the various lesion site and the different activation patterns of individual stroke survivors, personalized lesion profiles and anatomical features can be determined using finite element modelling, with lesion profiles generated from MRI and advanced algorithms calculating the current density to maximize the modulation effect. 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.

In this study, A randomized cross-over designed trial will be conducted to explore motor activation and reorganization changes before and after multisite HD-tDCS, conventional tDCS, and sham tDCS in stroke survivors. The stimulation effect will be evaluated by fMRI.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Multisite HD-tDCS group

Device:

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

Group Type EXPERIMENTAL

multisite HD-tDCS

Intervention Type 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

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.

Group Type SHAM_COMPARATOR

Sham stimulation

Intervention Type 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.

Conventional tDCS Group

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

Group Type ACTIVE_COMPARATOR

Conventional tDCS

Intervention Type DEVICE

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

Interventions

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multisite HD-tDCS

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.

Intervention Type DEVICE

Conventional tDCS

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

Intervention Type DEVICE

Sham stimulation

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes