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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Motor evoked potential (MEP)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •suffered from first-ever, ischemic or hemorrhagic, unilateral stroke, verified by neuroimaging examinations such as CT or MRI.
- •detectable motor evoked potentials from the affected first dorsal interosseous muscle;
- •provided written informed consent.
Exclusion Criteria
- •had any contraindication to transcranial magnetic stimulation;
- •had a known neurological disease excluding stroke, or psychiatric disease;
- •were using a psychostimulant, sedative, antidepressant, or antiepileptic medication.
Arms & Interventions
A single-session intermittent theta burst stimulation (iTBS)
The classical 600-pulse iTBS protocol is delivered to the motor hotspot over the ipsilesional hemisphere.
Intervention: Intermittent theta burst stimulation (iTBS) (Device)
A single-session 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.
Intervention: Sham intermittent theta burst stimulation (iTBS) (Device)
Outcomes
Primary Outcomes
Motor evoked potential (MEP)
Time Frame: 10 minutes after a single-session iTBS stimulation
Single TMS pulses with suprathreshold intensity (120% of resting motor threshold of the stimulated cortex) applied to the primary motor cortex (M1) can produce recordable MEPs in contralateral muscles; additionally, the peak-to-peak amplitude of MEPs can be used to represent the corticospinal excitability
Transcranial magnetic stimulation-evoked potential
Time Frame: 10 minutes after a single-session iTBS stimulation
Single pulses evoked an initial response in electroencephalogram, followed by a series of time- and phase-locked positive and negative deflections which could spread to the connected brain areas. The evoked potential is called transcranial magnetic stimulation-evoked potential.
Transcranial magnetic stimulation-evoked potential
Time Frame: Baseline (before iTBS stimulation)
Single pulses evoked an initial response in electroencephalogram, followed by a series of time- and phase-locked positive and negative deflections which could spread to the connected brain areas. The evoked potential is called transcranial magnetic stimulation-evoked potential.
Motor evoked potential (MEP)
Time Frame: Baseline (before iTBS stimulation)
Single TMS pulses with suprathreshold intensity (120% of resting motor threshold of the stimulated cortex) applied to the primary motor cortex (M1) can produce recordable MEPs in contralateral muscles; additionally, the peak-to-peak amplitude of MEPs can be used to represent the corticospinal excitability
Secondary Outcomes
- Cortical silent period(10 minutes after a single-session iTBS stimulation)
- Short-interval intracortical inhibition(10 minutes after a single-session iTBS stimulation)
- Intracortical facilitation(10 minutes after a single-session iTBS stimulation)
- Cortical silent period(Baseline (before iTBS stimulation))
- Short-interval intracortical inhibition(Baseline (before iTBS stimulation))
- Intracortical facilitation(Baseline (before iTBS stimulation))
Investigators
Kenneth N. K. Fong
Professor in Rehabilitation Sciences
The Hong Kong Polytechnic University