Efficacy of Integrated Therapy of rTMS and rPMS on Upper Limb Function in Patients With Stroke
NCT ID: NCT04265365
Last Updated: 2022-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2019-02-27
2023-02-11
Brief Summary
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Detailed Description
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Outcome measures include clinical based on International Classification of Functioning, Disability and Health (ICF) and motor control (Motor Evoked Potential, MEP; muscle tone assessment (MYOTON); pinch and grip strength and kinematics of upper extremity) assessments that administered at pretest, posttest, and 3-month follow-up. The aim of this study is to establish the novel assessment and treatment protocols in patients with stroke. The intervention will be conducted 10 times in 2 weeks (five times per week). The optimal effective treatment protocol of combination of rTMS and rPMS will also be established. The results of this study will be applied to the translational and evidence-based medicine of the neuro-rehabilitation field of stroke research.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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rTMS+rPMS_iTBS_R
In this group, they received intermittent theta burst stimulation(iTBS) on affected hemisphere after following iTBS at radial nerve on affected hand.
rTMS+rPMS_iTBS_R
Repetitive peripheral magnetic stimulation (rPMS) intermittent theta-burst stimulation pattern (iTBS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times at radial nerve on the affected hand(low pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times on affected hemisphere(low pulse: 1200 pulses in total).
rTMS+rPMS_cTBS_R
In this group, they received intermittent theta burst stimulation on affected hemisphere after following continuous theta burst stimulation(cTBS) at radial nerve on affected hand.
rTMS+rPMS_cTBS_R
Repetitive peripheral magnetic stimulation (rPMS) continuous burst stimulation pattern (cTBS) will intermittently give a cTBS treatment consists of a continuous train of TBS for 40 seconds repeated for 2 times at radial nerve on the affected hand(low pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times on affected hemisphere(low pulse: 1200 pulses in total).
rTMS +sham-rPMS
In this group, they received iTBS on affected hemisphere after following sham TBS stimulation at radial nerve on affected hand.
rTMS +sham-rPMS
Repetitive peripheral magnetic stimulation (rPMS) sham burst stimulation pattern (sham TBS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds at radial nerve on the affected hand(almost no pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times on affected hemisphere(low pulse: 1200 pulses in total).
rTMS+rPMS_iTBS_M/U
In this group, they received iTBS on affected hemisphere after following iTBS at median/ulnar nerve on affected hand.
rTMS+rPMS_iTBS_M/U
Repetitive peripheral magnetic stimulation (rPMS) intermittent theta-burst stimulation pattern (iTBS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times at median nerve/nervus ulnaris on the affected hand(low pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times on affected hemisphere(low pulse: 1200 pulses in total).
rTMS+rPMS_cTBS_M/U
In this group, they received iTBS on affected hemisphere after following cTBS at median/ulnar nerve on affected hand.
rTMS+rPMS_cTBS_M/U
Repetitive peripheral magnetic stimulation (rPMS) continuous burst stimulation pattern (cTBS) will intermittently give a cTBS treatment consists of a continuous train of TBS for 40 seconds repeated for 2 times at median nerve/nervus ulnaris on the affected hand(low pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times on affected hemisphere(low pulse: 1200 pulses in total).
sham-rTMS+sham-rPMS
In this group, they received iTBS on affected hemisphere after following sham TBS stimulation at median/ulnar nerve on affected hand.
sham-rTMS+sham-rPMS
Repetitive peripheral magnetic stimulation (rPMS) sham burst stimulation pattern (sham TBS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds at median nerve/nervus ulnaris on the affected hand(almost no pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds on affected hemisphere(almost no pulse: 1200 pulses in total).
rTMS + optimal-rPMS
In this group, patient received iTBS on affected hemisphere after following optimal repetitive peripheral magnetic stimulation(rPMS) on affected hand.
rTMS + optimal-rPMS
The optimal Repetitive peripheral magnetic stimulation (rPMS) depend on previous results to give an iTBS or cTBS. Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times on affected hemisphere(low pulse: 1200 pulses in total).
rTMS+ sham-rPMS
In this group, patient received iTBS on affected hemisphere after following sham repetitive peripheral magnetic stimulation on affected hand.
rTMS +sham-rPMS
Repetitive peripheral magnetic stimulation (rPMS) sham burst stimulation pattern (sham TBS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds at radial nerve on the affected hand(almost no pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times on affected hemisphere(low pulse: 1200 pulses in total).
sham-rTMS+optimal-rPMS
In this group, patient received sham iTBS on affected hemisphere after following optimal repetitive peripheral magnetic stimulation on affected hand.
sham-rTMS+optimal-rPMS
The optimal Repetitive peripheral magnetic stimulation (rPMS) depend on previous results to give an iTBS or cTBS. Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds on affected hemisphere(almost no pulse: 1200 pulses in total).
Interventions
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rTMS+rPMS_iTBS_R
Repetitive peripheral magnetic stimulation (rPMS) intermittent theta-burst stimulation pattern (iTBS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times at radial nerve on the affected hand(low pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times on affected hemisphere(low pulse: 1200 pulses in total).
rTMS+rPMS_cTBS_R
Repetitive peripheral magnetic stimulation (rPMS) continuous burst stimulation pattern (cTBS) will intermittently give a cTBS treatment consists of a continuous train of TBS for 40 seconds repeated for 2 times at radial nerve on the affected hand(low pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times on affected hemisphere(low pulse: 1200 pulses in total).
rTMS +sham-rPMS
Repetitive peripheral magnetic stimulation (rPMS) sham burst stimulation pattern (sham TBS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds at radial nerve on the affected hand(almost no pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times on affected hemisphere(low pulse: 1200 pulses in total).
rTMS+rPMS_iTBS_M/U
Repetitive peripheral magnetic stimulation (rPMS) intermittent theta-burst stimulation pattern (iTBS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times at median nerve/nervus ulnaris on the affected hand(low pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times on affected hemisphere(low pulse: 1200 pulses in total).
rTMS+rPMS_cTBS_M/U
Repetitive peripheral magnetic stimulation (rPMS) continuous burst stimulation pattern (cTBS) will intermittently give a cTBS treatment consists of a continuous train of TBS for 40 seconds repeated for 2 times at median nerve/nervus ulnaris on the affected hand(low pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times on affected hemisphere(low pulse: 1200 pulses in total).
sham-rTMS+sham-rPMS
Repetitive peripheral magnetic stimulation (rPMS) sham burst stimulation pattern (sham TBS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds at median nerve/nervus ulnaris on the affected hand(almost no pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds on affected hemisphere(almost no pulse: 1200 pulses in total).
rTMS + optimal-rPMS
The optimal Repetitive peripheral magnetic stimulation (rPMS) depend on previous results to give an iTBS or cTBS. Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times on affected hemisphere(low pulse: 1200 pulses in total).
sham-rTMS+optimal-rPMS
The optimal Repetitive peripheral magnetic stimulation (rPMS) depend on previous results to give an iTBS or cTBS. Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds on affected hemisphere(almost no pulse: 1200 pulses in total).
Eligibility Criteria
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Inclusion Criteria
* age 20-80 years
* unilateral brain lesions with unilateral hemiplegia
* brain wave examination without epileptic waves
Exclusion Criteria
* Patients with epilepsy
* Patients with aneurysm or cerebrovascular malformation
* Patients with mental illness
* Patients with degenerative diseases (such as neurodegenerative diseases)
* Patients with severe intelligence or language barriers (such as mental retardation or severe communication impairment)
* Patients with serious medical conditions (such as heart failure)
* Patients with acute disease (such as infection)
* Patients had metal implants in the body (such as cardiac rhythm or brain metal implants, metal clips for aneurysms)
* Patients had botox injection or surgery in the first half of the study
* pregnant woman or breastfeeding woman
* other obstacles (such as claustrophobia, obesity, etc.)
20 Years
80 Years
ALL
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Principal Investigators
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Chia-Ling Chen
Role: STUDY_DIRECTOR
Chang Gung Memorial Hospital
Locations
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Chang Gung Memoria Hospital
Taoyuan District, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Chang CS, Chen CL, Chen RS, Chen HC, Chen CY, Chung CY, Wu KP, Wu CY, Lin KC. Synergistic efficacy of repetitive peripheral magnetic stimulation on central intermittent theta burst stimulation for upper limb function in patients with stroke: a double-blinded, randomized controlled trial. J Neuroeng Rehabil. 2024 Apr 8;21(1):49. doi: 10.1186/s12984-024-01341-w.
Other Identifiers
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201802219A3
Identifier Type: -
Identifier Source: org_study_id
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