StrokeNCT04265365
Efficacy of Integrated Therapy of rTMS and rPMS on Upper Limb Function in Patients With Stroke
A study testing rTMS+rPMS_iTBS_R, rTMS+rPMS_cTBS_R and rTMS+rPMS_iTBS_M/U in people with Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Repetitive transcranial magnetic stimulation (rTMS) and repetitive peripheral magnetic stimulation (rPMS) are innovative treatments for patients with stroke. Therefore, the integrated therapy of rTMS and with repetitive peripheral magnetic stimulaiton (rPMS) is employed in this project. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- rTMS+rPMS_iTBS_R, rTMS+rPMS_cTBS_R and rTMS+rPMS_iTBS_M/U
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Feb 2019to 11 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first stoke and in stable phase
- age 20-80 years
- unilateral brain lesions with unilateral hemiplegia
- brain wave examination without epileptic waves
Who cannot join
- brain stem or cerebellar stroke
- 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)
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- 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.)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memoria Hospital
Taoyuan, 333
Chia-Ling Chen, MD,PhD, +886-3-3281200 ext. 8147, clingchen@gmail.com
Chia-Ling Chen, MD,PhD
About this study
Official title: Efficacy of Integrated Therapy of Repetitive Transcranial Magnetic Stimulation and Repetitive Peripheral Magnetic Stimulation on Upper Limb Function in Patients With Stroke
Repetitive transcranial magnetic stimulation (rTMS) and repetitive peripheral magnetic stimulation (rPMS) are innovative treatments for patients with stroke. Therefore, the integrated therapy of rTMS and with repetitive peripheral magnetic stimulaiton (rPMS) is employed in this project. This proposal aims at exploring different novel treatment strategies in the treatment of UE dysfunction in patients with stroke: rTMS integrated with rPMS.
Read the detailed description
Several aims in this study include identifying a better protocol of rPMS with Theta burst stimulation (TBS) and different nerves stimulation location, identifying the most optimal treatment protocols for rPMS (TBS treatment and nerve stimulation location), integrating novel treatment protocol (optimal rTMS + rPMS), comparing efficacy between integrated therapy of optimal rTMS and rPMS treatment and single rTMS or rPMS treatment, determining the mechanism of neuro-motor control, clinical predictors, and related biomarkers for the novel treatment protocol A total of 108-135 patients with stroke will be recruited. During phase 1 (year 1 and year 2), 72 to 90 participants will be randomly enrolled in different groups (12-15 participants in each group). For the first year, the participants will be randomly enrolled in 3 different groups according to the TBS mode (iTBS vs.cTBS). In the second year, the participants will be randomly enrolled in 3 different groups according to the stimulated nerves (radial, median/ulnar nerves) to find the optimal novel treatment protocols for UE dysfunction in patients with stroke. During phase 2 (2-3 years), 36 to 45 patients will be randomly enrolled into 3 groups of rTMS and rPMS integrated therapy to identify optimal integrated novel treatment protocol.
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
- Stroke
- Being tested
- rTMS+rPMS_iTBS_R, rTMS+rPMS_cTBS_R, rTMS +sham-rPMS, rTMS+rPMS_iTBS_M/U, rTMS+rPMS_cTBS_M/U
- Keywords
- Repetitive transcranial magnetic stimulation, Repetitive peripheral magnetic stimulation, stroke, novel treatment
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS+rPMS_iTBS_RDevice
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_RDevice
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-rPMSDevice
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/UDevice
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/UDevice
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-rPMSDevice
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-rPMSDevice
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-rPMSDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| rTMS+rPMS_iTBS_R | Experimental | In this group, they received intermittent theta burst stimulation(iTBS) on affected hemisphere after following iTBS at radial nerve on affected hand. Receives: Device: rTMS+rPMS_iTBS_R |
| rTMS+rPMS_cTBS_R | Experimental | 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. Receives: Device: rTMS+rPMS_cTBS_R |
| rTMS +sham-rPMS | Sham comparator | In this group, they received iTBS on affected hemisphere after following sham TBS stimulation at radial nerve on affected hand. Receives: Device: rTMS +sham-rPMS |
| rTMS+rPMS_iTBS_M/U | Experimental | In this group, they received iTBS on affected hemisphere after following iTBS at median/ulnar nerve on affected hand. Receives: Device: rTMS+rPMS_iTBS_M/U |
| rTMS+rPMS_cTBS_M/U | Experimental | In this group, they received iTBS on affected hemisphere after following cTBS at median/ulnar nerve on affected hand. Receives: Device: rTMS+rPMS_cTBS_M/U |
| sham-rTMS+sham-rPMS | Sham comparator | In this group, they received iTBS on affected hemisphere after following sham TBS stimulation at median/ulnar nerve on affected hand. Receives: Device: sham-rTMS+sham-rPMS |
| rTMS + optimal-rPMS | Experimental | In this group, patient received iTBS on affected hemisphere after following optimal repetitive peripheral magnetic stimulation(rPMS) on affected hand. Receives: Device: rTMS + optimal-rPMS |
| rTMS+ sham-rPMS | Experimental | In this group, patient received iTBS on affected hemisphere after following sham repetitive peripheral magnetic stimulation on affected hand. Receives: Device: rTMS +sham-rPMS |
| sham-rTMS+optimal-rPMS | Sham comparator | In this group, patient received sham iTBS on affected hemisphere after following optimal repetitive peripheral magnetic stimulation on affected hand. Receives: Device: sham-rTMS+optimal-rPMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Motion analysis at after six weeks of treatment and three month
All participants will be instructed to perform a series of upper-extremity tasks. The tasks include reaching and grasping. An 7-camera motion analysis system (Vicon system, 3-D Oxfort Metrics Ltd, Oxford, UK) is used in conjunction with a personal computer to capture the movement of markers placed on the participant's body; analog signals were collected simultaneously. Movements were recorded at 120 Hz and digitally low-pass filtered at 5 Hz using a second-order Butterworth filter. Reference markers are placed on the distal interphalangeal joints of the thumb and index finger, the styloid process of the ulna, proximal end of the second metacarpal, and the object.
Measured: baseline, after 6 weeks of treatment, 3 months
Change from baseline Motor evoked potential at after six weeks of treatment and three month
The comparison of baseline of Motor Evoked Potential for stroke after different therapy, including resting motor threshold (RMT), active motor thresholds (AMT), input-output curve (IO curve) and stationary period.
Measured: baseline, after 6 weeks of treatment, 3 months
Change from baseline Myoton at after six weeks of treatment and three month
The comparison of baseline of Myoton for stroke after different therapy, assessing the functional status of skeletal muscle.
Measured: baseline, after 6 weeks of treatment, 3 months
Change from baseline Muscle strength at after six weeks of treatment and three month
The comparison of baseline of Muscle strength for stroke after different therapy, including lateral pinch, palmar pinch, and tip pinch.
Measured: baseline, after 6 weeks of treatment, 3 months
Change from baseline Brunnstrom stage at after six weeks of treatment and three month
The Brunnstrom stage is used to classify the severity of stroke patient according to specific movement.
Measured: baseline, after 6 weeks of treatment, 3 months
Change from baseline Fugl Meyer Assessment at after six weeks of treatment and three month
The Fugl Meyer Assessment is used to measure upper and lower extremity motor , range of motion, sensation, pain and balance.
Measured: baseline, after 6 weeks of treatment, 3 months
Change from baseline Modified Ashworth Scale at after six weeks of treatment and three month
The Modified Ashworth Scale is used to measure the muscle tone of affected limb, for each item minimum value is 0 and maximum value is 4, higher scores mean a worse outcome.
Measured: baseline, after 6 weeks of treatment, 3 months
Secondary outcomes (9)
Change from baseline Action Research Arm Test at after six weeks of treatment and three month
The Action Research Arm Test is used to measure bilateral gross manual and finger dexterity.
Measured: baseline, after 6 weeks of treatment, 3 months
Change from baseline Box and Block Test at after six weeks of treatment and three month
The Box and Block Test (BBT) measures unilateral gross manual dexterity.
Measured: baseline, after 6 weeks of treatment, 3 months
Change from baseline Nine-Hole test at after six weeks of treatment and three month
The Nine-Hole Peg Test (NHPT) is used to measure finger dexterity in patients with various neurological diagnoses.
Measured: baseline, after 6 weeks of treatment, 3 months
Change from baseline Jebson Taylor Hand Function Test at after six weeks of treatment and three month
The Jebson Taylor Hand Function Test (JTHFT) is used to assess a broad range of unilateral hand functions required for activities of daily living(ADLs).
Measured: baseline, after 6 weeks of treatment, 3 months
Change from baseline Functional Independence Measure at after six weeks of treatment and three month
The purpose of Functional Independence Measure(FIM) is to understand and track adult's life function performance, progress and goal achievement. There are three main areas: self-care, mobility, and cognition. The score is from 1 to 7 points, 1 is completely dependent, and 7 is completely independent.
Measured: baseline, after 6 weeks of treatment, 3 months
Change from baseline Motor Activity Log at after six weeks of treatment and three month
The Motor Activity Log(MAL) is used to measure the quality and quantity of a stroke patient when performing activities using the affected hand.
Measured: baseline, after 6 weeks of treatment, 3 months
Change from baseline Wolf Motor Function Test at after six weeks of treatment and three month
The Wolf Motor Function Test(WMFT) is used to measure unilateral motor quality and strength.
Measured: baseline, after 6 weeks of treatment, 3 months
Change from baseline Nottingham Health Profile at after six weeks of treatment and three month
The Nottingham Health Profile(NHP) is a questionnaire that assesses the quality of life associated with health. There are a total of 38 items, divided into six sub-items: mobility, social isolation, emotional response, pain, sleep and energy.
Measured: baseline, after 6 weeks of treatment, 3 months
Change from baseline Stroke Impact Scale at after six weeks of treatment and three month
The Stroke Impact Scale(SIS) is used to measure the influence of several aspects after stroke, for each item minimum value is 1 and maximum value is 5, higher scores mean a better outcome.
Measured: baseline, after 6 weeks of treatment, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start27 Feb 2019
- Primary completion11 Dec 2022 (estimated)
- Study completion11 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Ling Chen, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265365
- Sponsor's protocol ID
- 201802219A3
- Status last verified
- Jul 2021
- First submitted
- 2 Feb 2020
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38589875
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Integrated Therapy of Repetitive Transcranial Magnetic Stimulation and Repetitive Peripheral Magnetic Stimulation on Upper Limb Function in Patients With Stroke
- ClinicalTrials.gov ID
- NCT04265365
- Acronym / sponsor ID
- 201802219A3
- Conditions
- Stroke
- Keywords
- Repetitive transcranial magnetic stimulation, Repetitive peripheral magnetic stimulation, stroke, novel treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 11 Dec 2022 (estimated)
- Study completion
- 11 Feb 2023 (estimated)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Repetitive transcranial magnetic stimulation (rTMS) and repetitive peripheral magnetic stimulation (rPMS) are innovative treatments for patients with stroke. Therefore, the integrated therapy of rTMS and with repetitive peripheral magnetic stimulaiton (rPMS) is employed in this project. This proposal aims at exploring different novel treatment strategies in the treatment of UE dysfunction in patients with stroke: rTMS integrated with rPMS.
Detailed description
Several aims in this study include identifying a better protocol of rPMS with Theta burst stimulation (TBS) and different nerves stimulation location, identifying the most optimal treatment protocols for rPMS (TBS treatment and nerve stimulation location), integrating novel treatment protocol (optimal rTMS + rPMS), comparing efficacy between integrated therapy of optimal rTMS and rPMS treatment and single rTMS or rPMS treatment, determining the mechanism of neuro-motor control, clinical predictors, and related biomarkers for the novel treatment protocol A total of 108-135 patients with stroke will be recruited. During phase 1 (year 1 and year 2), 72 to 90 participants will be randomly enrolled in different groups (12-15 participants in each group). For the first year, the participants will be randomly enrolled in 3 different groups according to the TBS mode (iTBS vs.cTBS). In the second year, the participants will be randomly enrolled in 3 different groups according to the stimulated nerves (radial, median/ulnar nerves) to find the optimal novel treatment protocols for UE dysfunction in patients with stroke. During phase 2 (2-3 years), 36 to 45 patients will be randomly enrolled into 3 groups of rTMS and rPMS integrated therapy to identify optimal integrated novel treatment protocol.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| rTMS+rPMS_iTBS_R | Experimental | Device: rTMS+rPMS_iTBS_RIn this group, they received intermittent theta burst stimulation(iTBS) on affected hemisphere after following iTBS at radial nerve on affected hand. |
| rTMS+rPMS_cTBS_R | Experimental | Device: rTMS+rPMS_cTBS_RIn 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 +sham-rPMS | Sham comparator | Device: rTMS +sham-rPMSIn this group, they received iTBS on affected hemisphere after following sham TBS stimulation at radial nerve on affected hand. |
| rTMS+rPMS_iTBS_M/U | Experimental | Device: rTMS+rPMS_iTBS_M/UIn this group, they received iTBS on affected hemisphere after following iTBS at median/ulnar nerve on affected hand. |
| rTMS+rPMS_cTBS_M/U | Experimental | Device: rTMS+rPMS_cTBS_M/UIn this group, they received iTBS on affected hemisphere after following cTBS at median/ulnar nerve on affected hand. |
| sham-rTMS+sham-rPMS | Sham comparator | Device: sham-rTMS+sham-rPMSIn this group, they received iTBS on affected hemisphere after following sham TBS stimulation at median/ulnar nerve on affected hand. |
| rTMS + optimal-rPMS | Experimental | Device: rTMS + optimal-rPMSIn this group, patient received iTBS on affected hemisphere after following optimal repetitive peripheral magnetic stimulation(rPMS) on affected hand. |
| rTMS+ sham-rPMS | Experimental | Device: rTMS +sham-rPMSIn this group, patient received iTBS on affected hemisphere after following sham repetitive peripheral magnetic stimulation on affected hand. |
| sham-rTMS+optimal-rPMS | Sham comparator | Device: sham-rTMS+optimal-rPMSIn this group, patient received sham iTBS on affected hemisphere after following optimal repetitive peripheral magnetic stimulation on affected hand. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- first stoke and in stable phase
- age 20-80 years
- unilateral brain lesions with unilateral hemiplegia
- brain wave examination without epileptic waves
Key exclusion criteria (12 listed)
- brain stem or cerebellar stroke
- Patients with epilepsy
- Patients with aneurysm or cerebrovascular malformation
- Patients with mental illness
- Patients with degenerative diseases (such as neurodegenerative diseases)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMS+rPMS_iTBS_RRepetitive 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). | Device | rTMS+rPMS_iTBS_R |
| rTMS+rPMS_cTBS_RRepetitive 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). | Device | rTMS+rPMS_cTBS_R |
| rTMS +sham-rPMSRepetitive 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). | Device | rTMS +sham-rPMS, rTMS+ sham-rPMS |
| rTMS+rPMS_iTBS_M/URepetitive 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). | Device | rTMS+rPMS_iTBS_M/U |
| rTMS+rPMS_cTBS_M/URepetitive 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). | Device | rTMS+rPMS_cTBS_M/U |
| sham-rTMS+sham-rPMSRepetitive 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). | Device | sham-rTMS+sham-rPMS |
| rTMS + optimal-rPMSThe 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). | Device | rTMS + optimal-rPMS |
| sham-rTMS+optimal-rPMSThe 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). | Device | sham-rTMS+optimal-rPMS |
Primary outcome
Change from baseline Motion analysis at after six weeks of treatment and three month
Time frame: baseline, after 6 weeks of treatment, 3 months
All participants will be instructed to perform a series of upper-extremity tasks. The tasks include reaching and grasping. An 7-camera motion analysis system (Vicon system, 3-D Oxfort Metrics Ltd, Oxford, UK) is used in conjunction with a personal computer to capture the movement of markers placed on the participant's body; analog signals were collected simultaneously. Movements were recorded at 120 Hz and digitally low-pass filtered at 5 Hz using a second-order Butterworth filter. Reference markers are placed on the distal interphalangeal joints of the thumb and index finger, the styloid process of the ulna, proximal end of the second metacarpal, and the object.
Change from baseline Motor evoked potential at after six weeks of treatment and three month
Time frame: baseline, after 6 weeks of treatment, 3 months
The comparison of baseline of Motor Evoked Potential for stroke after different therapy, including resting motor threshold (RMT), active motor thresholds (AMT), input-output curve (IO curve) and stationary period.
Change from baseline Myoton at after six weeks of treatment and three month
Time frame: baseline, after 6 weeks of treatment, 3 months
The comparison of baseline of Myoton for stroke after different therapy, assessing the functional status of skeletal muscle.
Change from baseline Muscle strength at after six weeks of treatment and three month
Time frame: baseline, after 6 weeks of treatment, 3 months
The comparison of baseline of Muscle strength for stroke after different therapy, including lateral pinch, palmar pinch, and tip pinch.
Change from baseline Brunnstrom stage at after six weeks of treatment and three month
Time frame: baseline, after 6 weeks of treatment, 3 months
The Brunnstrom stage is used to classify the severity of stroke patient according to specific movement.
Change from baseline Fugl Meyer Assessment at after six weeks of treatment and three month
Time frame: baseline, after 6 weeks of treatment, 3 months
The Fugl Meyer Assessment is used to measure upper and lower extremity motor , range of motion, sensation, pain and balance.
Change from baseline Modified Ashworth Scale at after six weeks of treatment and three month
Time frame: baseline, after 6 weeks of treatment, 3 months
The Modified Ashworth Scale is used to measure the muscle tone of affected limb, for each item minimum value is 0 and maximum value is 4, higher scores mean a worse outcome.
9 secondary outcomes
Change from baseline Action Research Arm Test at after six weeks of treatment and three month
Time frame: baseline, after 6 weeks of treatment, 3 months
Change from baseline Box and Block Test at after six weeks of treatment and three month
Time frame: baseline, after 6 weeks of treatment, 3 months
Change from baseline Nine-Hole test at after six weeks of treatment and three month
Time frame: baseline, after 6 weeks of treatment, 3 months
Change from baseline Jebson Taylor Hand Function Test at after six weeks of treatment and three month
Time frame: baseline, after 6 weeks of treatment, 3 months
Change from baseline Functional Independence Measure at after six weeks of treatment and three month
Time frame: baseline, after 6 weeks of treatment, 3 months
Change from baseline Motor Activity Log at after six weeks of treatment and three month
Time frame: baseline, after 6 weeks of treatment, 3 months
Change from baseline Wolf Motor Function Test at after six weeks of treatment and three month
Time frame: baseline, after 6 weeks of treatment, 3 months
Change from baseline Nottingham Health Profile at after six weeks of treatment and three month
Time frame: baseline, after 6 weeks of treatment, 3 months
Change from baseline Stroke Impact Scale at after six weeks of treatment and three month
Time frame: baseline, after 6 weeks of treatment, 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Derived from this study: PubMed 38589875Chang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Ling Chen study director
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS+rPMS_iTBS_R, rTMS+rPMS_cTBS_R and rTMS+rPMS_iTBS_M/U in people with Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chia-Ling Chen, MD, PhD (+886-3-3281200 ext. 8148, clingchen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Motion analysis at after six weeks of treatment and three month (time frame: baseline, after 6 weeks of treatment, 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04265365, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.