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

Sponsor
The Hong Kong Polytechnic University (Other)
Overall Status
Completed
CT.gov ID
NCT05509686
Collaborator
(none)
21
1
2
22
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Intermittent theta burst stimulation (iTBS)
  • Device: Sham intermittent theta burst stimulation (iTBS)
N/A

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
Actual Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 15, 2020
Actual Primary Completion Date :
Jul 30, 2021
Actual Study Completion Date :
May 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: A single-session intermittent theta burst stimulation (iTBS)

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

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.

Sham Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Transcranial magnetic stimulation-evoked potential [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.

  2. Transcranial magnetic stimulation-evoked potential [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.

  3. Motor evoked potential (MEP) [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

  4. Motor evoked potential (MEP) [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

Secondary Outcome Measures

  1. Cortical silent period [Baseline (before iTBS stimulation)]

    The cortical silent period (cSP) is a protocol measuring the intracortical inhibition, in which suprathreshold test pulses (120% of resting motor threshold of the stimulated cortex) are applied to the contralateral M1, while participants sustain 30% maximum voluntary contraction. Specifically, cSP refers to the interruption of background electromyographic (EMG) activity after the TMS pulse.

  2. Cortical silent period [10 minutes after a single-session iTBS stimulation]

    The cortical silent period (cSP) is a protocol measuring the intracortical inhibition, in which suprathreshold test pulses (120% of resting motor threshold of the stimulated cortex) are applied to the contralateral M1, while participants sustain 30% maximum voluntary contraction. Specifically, cSP refers to the interruption of background electromyographic (EMG) activity after the TMS pulse.

  3. Short-interval intracortical inhibition [Baseline (before iTBS stimulation)]

    Short-interval intracortical inhibition (SICI) is a form of paired-pulse protocol, in which a subthreshold conditioning pulse is delivered 2 ms before a suprathreshold test pulse. Theoretically, the amplitude of motor-evoked potentials (MEPs) evoked by a test pulse at a given intensity is suppressed compared with that evoked by a single pulse at the same intensity. Eight trials are recorded, with inter-trial intervals ranging from 4 s to 5 s. The intensity of test pulses is fixed at 120% of the resting motor threshold, and the intensity of the conditioning pulse is set at 80% of the resting motor threshold. The result of SICI is expressed as the ratio of a paired-pulse MEP amplitude to a single-pulse MEP amplitude.

  4. Short-interval intracortical inhibition [10 minutes after a single-session iTBS stimulation]

    Short-interval intracortical inhibition (SICI) is a form of paired-pulse protocol, in which a subthreshold conditioning pulse is delivered 2 ms before a suprathreshold test pulse. Theoretically, the amplitude of motor-evoked potentials (MEPs) evoked by a test pulse at a given intensity is suppressed compared with that evoked by a single pulse at the same intensity. Eight trials are recorded, with inter-trial intervals ranging from 4 s to 5 s. The intensity of test pulses is fixed at 120% of the resting motor threshold, and the intensity of the conditioning pulse is set at 80% of the resting motor threshold. The result of SICI is expressed as the ratio of a paired-pulse MEP amplitude to a single-pulse MEP amplitude.

  5. Intracortical facilitation [Baseline (before iTBS stimulation)]

    The setups for the intensity of intracortical facilitation (ICF) are almost the same as those for SICI; however, the interstimulus interval is longer, 10 ms. Eight trials are recorded, with inter-trial intervals ranging from 4 s to 5 s. The intensity of test pulses is fixed at 120% of the resting motor threshold, and the intensity of the conditioning pulse is set at 80% of the resting motor threshold. The result of ICF is expressed as the ratio of a paired-pulse MEP amplitude to a single-pulse MEP amplitude.

  6. Intracortical facilitation [10 minutes after a single-session iTBS stimulation]

    The setups for the intensity of intracortical facilitation (ICF) are almost the same as those for SICI; however, the interstimulus interval is longer, 10 ms. Eight trials are recorded, with inter-trial intervals ranging from 4 s to 5 s. The intensity of test pulses is fixed at 120% of the resting motor threshold, and the intensity of the conditioning pulse is set at 80% of the resting motor threshold. The result of ICF is expressed as the ratio of a paired-pulse MEP amplitude to a single-pulse MEP amplitude.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kenneth FONG Hong Kong Hong Kong 000000

Sponsors and Collaborators

  • The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Kenneth Fong, PhD, Hong Kong Polytechnic University, QT517, Hung Hom

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kenneth N. K. Fong, Professor in Rehabilitation Sciences, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT05509686
Other Study ID Numbers:
  • HSEARS20200621001
First Posted:
Aug 22, 2022
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kenneth N. K. Fong, Professor in Rehabilitation Sciences, The Hong Kong Polytechnic University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2022