NCT05509686

The Immediate Effects of Intermittent Theta Burst Stimulation on Intracortical Excitability of the Primary Motor Cortex in Patients With Chronic Stroke

The Immediate Effects of Intermittent Theta Burst Stimulation on Intracortical Excitability of the Primary Motor Cortex in Patients With Chronic Stroke: A Concurrent TMS-EEG Sham-controlled Crossover Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is to investigate the immediate effects of intermittent theta burst stimulation (iTBS) on intracortical excitatory and inhibitory circuits, neural connectivity, and network properties in patients with chronic stroke, using transcranial magnetic stimulation and electroencephalogram (TMS-EEG) and TMS-electromyography (EMG) and approaches.

Detailed description

The neurophysiological effect of intermittent theta burst stimulation (iTBS) has been examined with TMS-electromyography (EMG)-based outcomes in healthy people; however, its effects in intracortical excitability and inhibition are largely unknown in patients with stroke. Concurrent transcranial magnetic stimulation and electroencephalogram (TMS-EEG) recording can be used to investigate both intracortical excitatory and inhibitory circuits of the primary motor cortex (M1) and the property of brain networks. This study is to investigate the immediate effects of iTBS on intracortical excitatory and inhibitory circuits, neural connectivity, and network properties in patients with chronic stroke, using TMS-EEG and TMS-EMG approaches. In this randomized, sham-controlled, crossover study, 21 patients with chronic stroke receive two separate stimulation conditions: a single-session iTBS or sham stimulation applied to the ipsilesional M1, in two separate visits, with a washout period of five to seven days between the two visits after crossover. A battery of TMS-EMG and TMS-EEG measurements are taken before and immediately after stimulation during the visit.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Intermittent theta burst stimulation (iTBS)	A single-session standard 600-pulse intermittent theta burst stimulation (iTBS) is applied to the ipsilesional primary motor cortex.
DEVICE	Sham intermittent theta burst stimulation (iTBS)	The sham stimulation is the same as that of iTBS, but the coil is placed five centimeters away from the scalp. Electrical field simulation shows that the setups for sham stimulation would not induce any valid cortical activation.

Timeline

• Start date: 2020-07-15
• Primary completion: 2021-07-30
• Completion: 2022-05-15
• First posted: 2022-08-22
• Last updated: 2022-08-22

Locations

1 site across 1 country: Hong Kong