Optimization of Time Parameters of Priming iTBS for Poststroke Motor Rehabilitation

NCT06612437 | Completed DMC

• 1 other identifier: HSEARS20240229006
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

Brief 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. Using electroencephalography (EEG) to explore potential sensorimotor neuroplasticity underying stroke.

Conditions

Stroke; Stroke Rehabilitation

Keywords

Stroke; TMS; TBS; EEG

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

• Action Research Arm Test (ARAT)

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

Other Outcomes (2)

• Sensorimotor event-related desynchronization

  Baseline (Day 1, prior to first treatment), Day 1 (immediately after first treatment), Day 21 (immediately after 10th treatment)

• Sensory evoked potential

  Baseline (Day 1, prior to first treatment), Day 1 (immediately after first treatment), Day 21 (immediately after 10th treatment)

Study Arms (4)

cTBS primed iTBS with 3-minute interval

EXPERIMENTAL

short interval(3min) between cTBS and iTBS

Device: continuous theta burst stimulation (cTBS); Device: intermittent theta burst stimulation (iTBS); Device: Robot-assisted training

cTBS primed iTBS with 10-minute interval

EXPERIMENTAL

experimental interval(10min) between cTBS and iTBS

Device: continuous theta burst stimulation (cTBS); Device: intermittent theta burst stimulation (iTBS); Device: Robot-assisted training

cTBS primed iTBS with 20-minute interval

EXPERIMENTAL

long interval(20min) between cTBS and iTBS

Device: continuous theta burst stimulation (cTBS); Device: intermittent theta burst stimulation (iTBS); Device: Robot-assisted training

Non-primed iTBS

SHAM COMPARATOR

iTBS alone

Device: intermittent theta burst stimulation (iTBS); Device: Robot-assisted training

Interventions

continuous theta burst stimulation (cTBS) 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.

Also known as: Repetitive transcranial magnetic stimulation (rTMS)

cTBS primed iTBS with 10-minute interval; cTBS primed iTBS with 20-minute interval; cTBS primed iTBS with 3-minute interval

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.

Non-primed iTBS; cTBS primed iTBS with 10-minute interval; cTBS primed iTBS with 20-minute interval; cTBS primed iTBS with 3-minute interval

Robot-assisted training 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; cTBS primed iTBS with 10-minute interval; cTBS primed iTBS with 20-minute interval; cTBS primed iTBS with 3-minute interval

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of hemorrhagic or ischemic stroke using computed tomography (CT) or magnetic resonance imaging (MRI).
• the first-ever stroke with unilateral hemiplegia.
• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (2)

The Hong Kong Polytechnic University

Hong Kong, HK, Hong Kong

Location

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 35317611 RESULT

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

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

Study Record Dates

• First Submitted: September 21, 2024
• First Posted: September 25, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)