Skip to main content
Clinical Trials/NCT05509686
NCT05509686
Completed
N/A

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

The Hong Kong Polytechnic University1 site in 1 country21 target enrollmentJuly 15, 2020
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
The Hong Kong Polytechnic University
Enrollment
21
Locations
1
Primary Endpoint
Motor evoked potential (MEP)
Status
Completed
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
July 15, 2020
End Date
May 15, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kenneth N. K. Fong

Professor in Rehabilitation Sciences

The Hong Kong Polytechnic University

Eligibility Criteria

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.

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.

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)

Study Sites (1)

Loading locations...

Similar Trials