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

The Hong Kong Polytechnic University

Status: Completed

Conditions: Stroke

Treatments: Device: Intermittent theta burst stimulation (iTBS); Device: Sham intermittent theta burst stimulation (iTBS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05509686

HSEARS20200621001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. suffered from first-ever, ischemic or hemorrhagic, unilateral stroke, verified by neuroimaging examinations such as CT or MRI.
2. detectable motor evoked potentials from the affected first dorsal interosseous muscle;
3. provided written informed consent.

Exclusion criteria

1. had any contraindication to transcranial magnetic stimulation;
2. had a known neurological disease excluding stroke, or psychiatric disease;
3. were using a psychostimulant, sedative, antidepressant, or antiepileptic medication.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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21 participants in 2 patient groups

A single-session intermittent theta burst stimulation (iTBS)

Experimental group

Description:

The classical 600-pulse iTBS protocol is delivered to the motor hotspot over the ipsilesional hemisphere.

Treatment:

Device: Intermittent theta burst stimulation (iTBS)

A single-session sham intermittent theta burst stimulation (iTBS)

Sham Comparator group

Description:

The sham stimulation is the same as that of iTBS, but the coil is placed five centimeters away from the scalp.

Treatment:

Device: Sham intermittent theta burst stimulation (iTBS)