Optimization of Time Parameters of Priming iTBS for Poststroke Motor Rehabilitation (TMS)

January 3, 2026 updated by: Kenneth N. K. Fong, The Hong Kong Polytechnic University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The Hong Kong Polytechnic University
    • HK
      • Hong Kong, HK, Hong Kong
        • The Hong Kong Polytechnic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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, & 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) < 22/30) and communication deficiency.
  4. extreme spasticity over the hemiparetic upper limb (Modified Ashworth Score>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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cTBS primed iTBS with 3-minute interval
short interval(3min) between cTBS and iTBS
Device: 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.
Other Names:
  • Repetitive transcranial magnetic stimulation (rTMS)
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.
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.
Experimental: cTBS primed iTBS with 10-minute interval
experimental interval(10min) between cTBS and iTBS
Device: 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.
Other Names:
  • Repetitive transcranial magnetic stimulation (rTMS)
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.
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.
Experimental: cTBS primed iTBS with 20-minute interval
long interval(20min) between cTBS and iTBS
Device: 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.
Other Names:
  • Repetitive transcranial magnetic stimulation (rTMS)
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.
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.
Sham Comparator: Non-primed iTBS
iTBS alone
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer assessment of upper extremity (FMA-UE)
Time Frame: Baseline (Day 1, prior to first treatment), Day 21 (immediately after 10th treatment) , 1 month after completion of treatment
Fugl-Meyer Assessment of upper extremity (FMA-UE) scale is an index to assess the sensorimotor impairment in individuals who have had stroke. It contains motor assessment and sensory assessment. The motor parts includes 33 items assessing the movement, coordination and reflex actions of the shoulder, elbow, forearm and wrist, as well as the hand joints of the paretic arm. Each item consists of a three-point scale (0, 1 and 2), with a total maximum score of 66. The sensory component consists of 6 items assessing light touch and position of the shoulder, elbow, wrist, and thumb. Each item consists of a three-point scale (0, 1, and 2) with a total score of 12 points.
Baseline (Day 1, prior to first treatment), Day 21 (immediately after 10th treatment) , 1 month after completion of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Action Research Arm Test (ARAT)
Time Frame: Baseline (Day 1, prior to first treatment), Day 21 (immediately after 10th treatment) , 1 month after completion of treatment
The ARAT is a clinical assessment for upper limb functional activities for patients with stroke, which mainly focuses on the proximal and distal upper limb function. It consists of four subscales: grasp, grip, pinch and gross movement. It has 19 movement tasks, each graded using a four-point scale (total scores range from 0 to 57) (McDonnell, 2008). The MCID of ARAT is 5.70 points (Van der Lee et al., 2001).
Baseline (Day 1, prior to first treatment), Day 21 (immediately after 10th treatment) , 1 month after completion of treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensorimotor event-related desynchronization
Time Frame: Baseline (Day 1, prior to first treatment), Day 1 (immediately after first treatment), Day 21 (immediately after 10th treatment)
Electroencephalographical assessment for cortical activation induced by movement and mirror visual feedback-based observation of movement
Baseline (Day 1, prior to first treatment), Day 1 (immediately after first treatment), Day 21 (immediately after 10th treatment)
Sensory evoked potential
Time Frame: Baseline (Day 1, prior to first treatment), Day 1 (immediately after first treatment), Day 21 (immediately after 10th treatment)
Electroencephalographical assessment for cortical activation induced by periphral magenetic stimulation over the bilateral forearm.
Baseline (Day 1, prior to first treatment), Day 1 (immediately after first treatment), Day 21 (immediately after 10th treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Actual)

December 1, 2025

Study Completion (Actual)

December 1, 2025

Study Registration Dates

First Submitted

September 21, 2024

First Submitted That Met QC Criteria

September 21, 2024

First Posted (Actual)

September 25, 2024

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 3, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSEARS20240229006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To protect the privacy of patients

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on continuous theta burst stimulation (cTBS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe