Clinical trial NCT05509686: The Immediate Effects of Intermittent Theta Burst Stimulation on Intracortical Excitability of the Primary Motor Cortex in Patients With Chronic Stroke
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
theta burst stimulation
transcranial magnetic stimulation-evoked potentials
intracortical inhibition
cortical excitability
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Transcranial magnetic stimulation-evoked potential
timeFrame: Baseline (before iTBS stimulation)
measure: Transcranial magnetic stimulation-evoked potential
timeFrame: 10 minutes after a single-session iTBS stimulation
measure: Motor evoked potential (MEP)
timeFrame: Baseline (before iTBS stimulation)
measure: Motor evoked potential (MEP)
timeFrame: 10 minutes after a single-session iTBS stimulation
Secondary outcomes:
measure: Cortical silent period
timeFrame: Baseline (before iTBS stimulation)
measure: Cortical silent period
timeFrame: 10 minutes after a single-session iTBS stimulation
measure: Short-interval intracortical inhibition
timeFrame: Baseline (before iTBS stimulation)
measure: Short-interval intracortical inhibition
timeFrame: 10 minutes after a single-session iTBS stimulation
measure: Intracortical facilitation
timeFrame: Baseline (before iTBS stimulation)
measure: Intracortical facilitation
timeFrame: 10 minutes after a single-session iTBS stimulation
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Kenneth FONG
Study officials:
affiliation: Hong Kong Polytechnic University, QT517, Hung Hom
name: Kenneth Fong, PhD
role: PRINCIPAL_INVESTIGATOR
References: