The Immediate Effects of Intermittent Theta Burst Stimulation on Intracortical Excitability of the Primary Motor Cortex in Patients With Chronic Stroke
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Jul 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2022
CompletedFirst Submitted
Initial submission to the registry
August 18, 2022
CompletedFirst Posted
Study publicly available on registry
August 22, 2022
CompletedAugust 22, 2022
August 1, 2022
1 year
August 18, 2022
August 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Transcranial magnetic stimulation-evoked potential
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.
Baseline (before iTBS stimulation)
Transcranial magnetic stimulation-evoked potential
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.
10 minutes after a single-session iTBS stimulation
Motor evoked potential (MEP)
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
Baseline (before iTBS stimulation)
Motor evoked potential (MEP)
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
10 minutes after a single-session iTBS stimulation
Secondary Outcomes (6)
Cortical silent period
Baseline (before iTBS stimulation)
Cortical silent period
10 minutes after a single-session iTBS stimulation
Short-interval intracortical inhibition
Baseline (before iTBS stimulation)
Short-interval intracortical inhibition
10 minutes after a single-session iTBS stimulation
Intracortical facilitation
Baseline (before iTBS stimulation)
- +1 more secondary outcomes
Study Arms (2)
A single-session intermittent theta burst stimulation (iTBS)
EXPERIMENTALThe classical 600-pulse iTBS protocol is delivered to the motor hotspot over the ipsilesional hemisphere.
A single-session sham intermittent theta burst stimulation (iTBS)
SHAM COMPARATORThe sham stimulation is the same as that of iTBS, but the coil is placed five centimeters away from the scalp.
Interventions
A single-session standard 600-pulse intermittent theta burst stimulation (iTBS) is applied to the ipsilesional primary motor cortex.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kenneth FONG
Hong Kong, 000000, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth Fong, PhD
Hong Kong Polytechnic University, QT517, Hung Hom
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor in Rehabilitation Sciences
Study Record Dates
First Submitted
August 18, 2022
First Posted
August 22, 2022
Study Start
July 15, 2020
Primary Completion
July 30, 2021
Study Completion
May 15, 2022
Last Updated
August 22, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share
The data will be shared for research purpose upon reasonable request.