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AzTrials

StrokeTMSNCT06612437

Optimization of Time Parameters of Priming iTBS for Poststroke Motor Rehabilitation

A study testing continuous theta burst stimulation (cTBS), intermittent theta burst stimulation (iTBS) and Robot-assisted training in people with Stroke and Stroke Rehabilitation, run by The Hong Kong Polytechnic University at 2 sites in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Stroke, Stroke Rehabilitation
What is being tested?
continuous theta burst stimulation (cTBS), intermittent theta burst stimulation (iTBS) and Robot-assisted training
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
62 participants
Where
2 sitesHong Kong
Study dates
1 Oct 2024to 1 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • diagnosis of any clinically significant or unstable medical disorder.
  • any contraindications to TMS based on the TMS safety guidelines (Rossi, Hallett, Rossini, \& Pascual-Leone, 2011).
  • 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.
  • extreme spasticity over the hemiparetic upper limb (Modified Ashworth Score\>2) or severe pain that hindered movement.
  • a history of neurological or psychiatric disease excluding stroke, or current use of psychoactive medication (sedatives, antipsychotics, antidepressants, etc.).

Trial locations and contacts

2 sites in 1 country.

Hong Kong2 sites

  • The Hong Kong Polytechnic University

    Hong Kong, HK

  • The Hong Kong Polytechnic University

    Hong Kong

Other trials in Hong Kong

About this study

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.

Read the 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.

Being tested
continuous theta burst stimulation (cTBS), intermittent theta burst stimulation (iTBS), Robot-assisted training
Keywords
Stroke, TMS, TBS, EEG
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • continuous theta burst stimulation (cTBS)Device

    Also called Repetitive transcranial magnetic stimulation (rTMS)

    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)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 trainingDevice

    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.

Study groups in NCT06612437
Study groupRoleWhat they receive
cTBS primed iTBS with 3-minute intervalExperimentalshort interval(3min) between cTBS and iTBS
Receives: Device: continuous theta burst stimulation (cTBS); Device: intermittent theta burst stimulation (iTBS); Device: Robot-assisted training
cTBS primed iTBS with 10-minute intervalExperimentalexperimental interval(10min) between cTBS and iTBS
Receives: Device: continuous theta burst stimulation (cTBS); Device: intermittent theta burst stimulation (iTBS); Device: Robot-assisted training
cTBS primed iTBS with 20-minute intervalExperimentallong interval(20min) between cTBS and iTBS
Receives: Device: continuous theta burst stimulation (cTBS); Device: intermittent theta burst stimulation (iTBS); Device: Robot-assisted training
Non-primed iTBSSham comparatoriTBS alone
Receives: Device: intermittent theta burst stimulation (iTBS); Device: Robot-assisted training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fugl-Meyer assessment of upper extremity (FMA-UE)

    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.

    Measured: Baseline (Day 1, prior to first treatment), Day 21 (immediately after 10th treatment) , 1 month after completion of treatment

Secondary outcomes (1)

  1. Action Research Arm Test (ARAT)

    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).

    Measured: Baseline (Day 1, prior to first treatment), Day 21 (immediately after 10th treatment) , 1 month after completion of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2024
  2. Study start1 Oct 2024
  3. Primary completion1 Dec 2025
  4. Study completion1 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06612437
Sponsor's protocol ID
HSEARS20240229006
Acronym
TMS
Status last verified
Jan 2026
First submitted
21 Sep 2024
Last updated
6 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: To protect the privacy of patients

Publications

  • Zhang JJ, Bai Z, Fong KNK. Priming Intermittent Theta Burst Stimulation for Hemiparetic Upper Limb After Stroke: A Randomized Controlled Trial. Stroke. 2022 Jul;53(7):2171-2181. doi: 10.1161/STROKEAHA.121.037870. Epub 2022 Mar 23.

    PubMed 35317611

Questions about this trial

What is this clinical trial studying?

A study testing continuous theta burst stimulation (cTBS), intermittent theta burst stimulation (iTBS) and Robot-assisted training in people with Stroke and Stroke Rehabilitation, run by The Hong Kong Polytechnic University at 2 sites in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06612437, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.

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