NCT06612437

Optimization of Time Parameters of Priming iTBS for Poststroke Motor Rehabilitation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Stroke
• Stroke Rehabilitation

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-09-25
• Last updated: 2026-01-06

Locations

2 sites across 1 country: Hong Kong