Optimization of Time Parameters of Priming iTBS for Poststroke Motor Rehabilitation

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

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-12-01

Brief Summary

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The goal of this clinical trial is to identify the effect of different time intervals between continuous theta burst stimulation (cTBS) and intermittent theta burst stimulation(iTBS), on top of a standard robot-assisted training (RAT) for sensorimotor rehabilitation in patients with chronic stroke. Using electroencephalography (EEG) to explore potential sensorimotor neuroplasticity underying stroke.

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Detailed Description

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Delivering Intermittent theta burst stimulation (iTBS) primed with continuous theta burst stimulation (cTBS) to the primary motor cortex (M1) may enhance the facilitatory effect of iTBS on the stimulated M1 through metaplasticity. Previous studies have verified the effectiveness of priming iTBS on improving motor rehabilitation in patients with stroke. However, the optimal time interval between cTBS and iTBS remains unknown. The aim of this clinical trial is to identify the effect of different time intervals between cTBS and iTBS, followed with a standard robot-assisted training (RAT) for sensorimotor rehabilitation in patients with chronic stroke. Using electroencephalography (EEG) to explore potential sensorimotor neuroplasticity. A three-arm randomized controlled trial (RCT) will be performed with an estimated total of 30 patients with chronic stroke. All participants will be randomly allocated to receive 10-session intervention of different TBS protocols (i.e., cTBS-3min interval-iTBS, cTBS-10min interval-iTBS and cTBS-20min interval-iTBS), delivered for 2-4 sessions per week, lasting for 3-4 weeks. All participants will receive a 20-minute standard RAT after each stimulation session. Primary outcome will be Fugl-Meyer Assessment-Upper Extremity scores (FMA-UE). Secondary outcomes will be Action Research Arm Test (ARAT), kinematic outcomes generated during RAT as well as EEG.

Conditions

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Stroke Stroke Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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cTBS primed iTBS with 3-minute interval

short interval(3min) between cTBS and iTBS

Group Type EXPERIMENTAL

continuous theta burst stimulation (cTBS)

Intervention Type DEVICE

Standard 600-pulse continuous theta burst stimulation (cTBS) can inhibit the corticomotor excitability. The cTBS will be delivered with an intensity of 70% individual resting motor threshold (RMT) of the hand knob over the contralesional M1.

intermittent theta burst stimulation (iTBS)

Intervention Type DEVICE

Standard 600-pulse intermittent theta burst stimulation (iTBS) can increase the corticomotor excitability. The iTBS will be delivered with an intensity of 70% individual resting motor threshold (RMT) of the hand knob over the contralesional M1.

Robot-assisted training

Intervention Type DEVICE

Fourier M2 upper limb rehabilitation robot (Fourier Intelligence Co. Ltd., Shanghai, China), will be used for upper limb proximal joints training. Fourier M2 upper limb rehab robot is an end-effector robot-assisted device. The device targets (1) flexion and extension of shoulder joint, (2) flexion and extension of elbow, (3) internal and external rotation of shoulder joint, and (4) abduction and adduction of shoulder joint, supported by tailored interactive TV games in the device.

cTBS primed iTBS with 10-minute interval

experimental interval(10min) between cTBS and iTBS

Group Type EXPERIMENTAL

continuous theta burst stimulation (cTBS)

Intervention Type DEVICE

Standard 600-pulse continuous theta burst stimulation (cTBS) can inhibit the corticomotor excitability. The cTBS will be delivered with an intensity of 70% individual resting motor threshold (RMT) of the hand knob over the contralesional M1.

intermittent theta burst stimulation (iTBS)

Intervention Type DEVICE

Standard 600-pulse intermittent theta burst stimulation (iTBS) can increase the corticomotor excitability. The iTBS will be delivered with an intensity of 70% individual resting motor threshold (RMT) of the hand knob over the contralesional M1.

Robot-assisted training

Intervention Type DEVICE

Fourier M2 upper limb rehabilitation robot (Fourier Intelligence Co. Ltd., Shanghai, China), will be used for upper limb proximal joints training. Fourier M2 upper limb rehab robot is an end-effector robot-assisted device. The device targets (1) flexion and extension of shoulder joint, (2) flexion and extension of elbow, (3) internal and external rotation of shoulder joint, and (4) abduction and adduction of shoulder joint, supported by tailored interactive TV games in the device.

cTBS primed iTBS with 20-minute interval

long interval(20min) between cTBS and iTBS

Group Type EXPERIMENTAL

continuous theta burst stimulation (cTBS)

Intervention Type DEVICE

Standard 600-pulse continuous theta burst stimulation (cTBS) can inhibit the corticomotor excitability. The cTBS will be delivered with an intensity of 70% individual resting motor threshold (RMT) of the hand knob over the contralesional M1.

intermittent theta burst stimulation (iTBS)

Intervention Type DEVICE

Standard 600-pulse intermittent theta burst stimulation (iTBS) can increase the corticomotor excitability. The iTBS will be delivered with an intensity of 70% individual resting motor threshold (RMT) of the hand knob over the contralesional M1.

Robot-assisted training

Intervention Type DEVICE

Fourier M2 upper limb rehabilitation robot (Fourier Intelligence Co. Ltd., Shanghai, China), will be used for upper limb proximal joints training. Fourier M2 upper limb rehab robot is an end-effector robot-assisted device. The device targets (1) flexion and extension of shoulder joint, (2) flexion and extension of elbow, (3) internal and external rotation of shoulder joint, and (4) abduction and adduction of shoulder joint, supported by tailored interactive TV games in the device.

Non-primed iTBS

iTBS alone

Group Type SHAM_COMPARATOR

intermittent theta burst stimulation (iTBS)

Intervention Type DEVICE

Standard 600-pulse intermittent theta burst stimulation (iTBS) can increase the corticomotor excitability. The iTBS will be delivered with an intensity of 70% individual resting motor threshold (RMT) of the hand knob over the contralesional M1.

Robot-assisted training

Intervention Type DEVICE

Fourier M2 upper limb rehabilitation robot (Fourier Intelligence Co. Ltd., Shanghai, China), will be used for upper limb proximal joints training. Fourier M2 upper limb rehab robot is an end-effector robot-assisted device. The device targets (1) flexion and extension of shoulder joint, (2) flexion and extension of elbow, (3) internal and external rotation of shoulder joint, and (4) abduction and adduction of shoulder joint, supported by tailored interactive TV games in the device.

Interventions

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continuous theta burst stimulation (cTBS)

Standard 600-pulse continuous theta burst stimulation (cTBS) can inhibit the corticomotor excitability. The cTBS will be delivered with an intensity of 70% individual resting motor threshold (RMT) of the hand knob over the contralesional M1.

Intervention Type DEVICE

intermittent theta burst stimulation (iTBS)

Standard 600-pulse intermittent theta burst stimulation (iTBS) can increase the corticomotor excitability. The iTBS will be delivered with an intensity of 70% individual resting motor threshold (RMT) of the hand knob over the contralesional M1.

Intervention Type DEVICE

Robot-assisted training

Fourier M2 upper limb rehabilitation robot (Fourier Intelligence Co. Ltd., Shanghai, China), will be used for upper limb proximal joints training. Fourier M2 upper limb rehab robot is an end-effector robot-assisted device. The device targets (1) flexion and extension of shoulder joint, (2) flexion and extension of elbow, (3) internal and external rotation of shoulder joint, and (4) abduction and adduction of shoulder joint, supported by tailored interactive TV games in the device.

Intervention Type DEVICE

Other Intervention Names

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Repetitive transcranial magnetic stimulation (rTMS)

Eligibility Criteria

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Inclusion Criteria

1. diagnosis of hemorrhagic or ischemic stroke using computed tomography (CT) or magnetic resonance imaging (MRI).
2. the first-ever stroke with unilateral hemiplegia.
3. 18-75 years old.
4. chronic stroke ( ≥ 6 months).
5. residual hemiparetic upper limb functional level in the Functional Test for the Hemiplegic Upper Extremity (FTHUE-HK) ≥ 2.
6. can understand and read Chinese.
7. signed informed consent.

Exclusion Criteria

1. diagnosis of any clinically significant or unstable medical disorder.
2. any contraindications to TMS based on the TMS safety guidelines (Rossi, Hallett, Rossini, \&amp; Pascual-Leone, 2011).
3. inability to follow treatment instructions due to severe cognitive (using the Hong Kong version of the Montreal Cognitive Assessment (MoCA-HK) \&lt; 22/30) and communication deficiency.
4. extreme spasticity over the hemiparetic upper limb (Modified Ashworth Score\&gt;2) or severe pain that hindered movement.
5. a history of neurological or psychiatric disease excluding stroke, or current use of psychoactive medication (sedatives, antipsychotics, antidepressants, etc.).

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes