StrokeNCT05053711
Augmented Efficacy of rPMS on the rTMS on Upper Limb Function in Patients With Stroke
A study testing rTMS+rPMS_iTBS_M, rTMS+rPMS_cTBS_M and rTMS+rPMS_iTBS_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, augmented efficacy of rPMS on the rTMS 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_M, rTMS+rPMS_cTBS_M and rTMS+rPMS_iTBS_U
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2021to Sep 2024
- 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)
Show all 12Show fewer
- 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
Chia-Ling Chen, MD,PhD, +886-3-3281200 ext. 8148, clingchen@gmail.com
About this study
Official title: Augmented Efficacy of Repetitive Peripheral Magnetic Stimulation on the Repetitive Transcranial Magnetic Stimulation on Upper Limb Function in Patients With Stroke: a Randomized Controlled Trial
Repetitive transcranial magnetic stimulation (rTMS) and repetitive peripheral magnetic stimulation (rPMS) are innovative treatments for patients with stroke. Therefore, augmented efficacy of rPMS on the rTMS is employed in this project. This proposal aims at exploring different novel treatment strategies in the treatment of UE dysfunction in patients with stroke: augmented efficacy of rPMS on the rTMS. Several aims in this study include (1) identifying the most optimal treatment protocols for rPMS (TBS treatment and nerve stimulation location), (2 ) establish a novel treatment protocol (augmented efficacy of rPMS on the rTMS), (3) identifying augmented efficacy of rPMS on the rTMS, (4) determining the mechanism of neuro-motor control, and (5) related biomarkers for the novel treatment protocol. The investigators applied a 3-year plan before, however, the Ministry of Science and Technology plan passed one year only (108-2314-B-182-043-). The investigators carried out the pilot study to investigate the augmented effects of rPMS (radial nerve) on the rTMS in the treatment of upper limb function in patients with stroke patients. The previous plan had preliminary results. This year the investigators will apply for a three-year plan to continue the previous pilot study for getting the comprehensive results.
Read the detailed description
This study intends to further explore whether rPMS intervention in different nerves can augment rTMS efficacy on upper limb function in patients with stroke. A total of 72-96 patients with stroke will be recruited in 2 phases and 36-48 participants will be divided into four groups according to their severity and the onset of stroke, and then randomly enrolled into 3 groups in each phase (12-16 participants in each group) based on different rPMS- stimulated methods and location. All patients will receive the rPMS in addition rTMS on the brain cortex. In phase 1, each patient will receive either one of three rPMS methods on median nerve (iTBS, cTBS, sham). During phase 2, each patient will receive either one of three rPMS methods on ulnar nerve. Outcome measures include clinical assessments based on International Classification of Functioning, Disability and Health (ICF) and motor control (Motor Evoked Potential, MEP, kinetics, and kinematics) that administered at pretest, posttest, and 3-month follow-up. This study aims to establish a novel assessment and treatment protocols in patients with stroke. The intervention will be conducted 10 times for each participant. The optimal effective treatment protocol of augmented efficacy of rPMS on the rTMS 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_M, rTMS+rPMS_cTBS_M, rTMS+sham rPMS_M, rTMS+rPMS_iTBS_U, rTMS+rPMS_cTBS_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_MDevice
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 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_MDevice
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 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_MDevice
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 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+rPMS_iTBS_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 ulnaris 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_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 ulnar 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_UDevice
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 ulnar nerve 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).
| Study group | Role | What they receive |
|---|---|---|
| rTMS+rPMS_iTBS_M | Experimental | In this group, they received iTBS on affected hemisphere after following iTBS at median nerve on affected hand. Receives: Device: rTMS+rPMS_iTBS_M |
| rTMS+rPMS_cTBS_M | Experimental | In this group, they received iTBS on affected hemisphere after following cTBS at median nerve on affected hand. Receives: Device: rTMS+rPMS_cTBS_M |
| rTMS+sham rPMS_M | Sham comparator | In this group, they received iTBS on affected hemisphere after following sham TBS stimulation at median nerve on affected hand. Receives: Device: rTMS+sham rPMS_M |
| rTMS+rPMS_iTBS_U | Experimental | In this group, they received iTBS on affected hemisphere after following iTBS at ulnar nerve on affected hand. Receives: Device: rTMS+rPMS_iTBS_U |
| rTMS+rPMS_cTBS_U | Experimental | In this group, they received iTBS on affected hemisphere after following cTBS at ulnar nerve on affected hand. Receives: Device: rTMS+rPMS_cTBS_U |
| rTMS+sham rPMS_U | Sham comparator | In this group, they received iTBS on affected hemisphere after following sham TBS stimulation at ulnar nerve on affected hand. Receives: Device: rTMS+sham rPMS_U |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Motion analysis at after 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 two weeks of treatment, 3 months
Change from baseline Motor evoked potential at afte 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 two weeks of treatment, 3 months
Change from baseline Myoton at after treatment and three month
The comparison of baseline of Myoton for stroke after different therapy, assessing the functional status of skeletal muscle, including tone or state of tension(natural oscillation frequency[Hz]), biochanical properties(dynamic stiffness [N/m], logarithmic decrement of natural oscillation), viscoelastic properties(mechanical stress relaxation time [ms], ratio of deformation and relaxation time, characterising Creep (Deborah number)).
Measured: baseline, after two weeks of treatment, 3 months
Change from baseline Muscle strength at after treatment and three month
The comparison of baseline of Muscle strength for stroke after different therapy, including lateral pinch, palmar pinch, and tip pinch, the strength will be tested by hand dynamometer.
Measured: baseline, after two weeks of treatment, 3 months
Change from baseline Brunnstrom stage at after treatment and three month
The Brunnstrom stage is used to classify the severity of stroke patient according to specific movement.
Measured: baseline, after two weeks of treatment, 3 months
Change from baseline Fugl Meyer Assessment at after 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 two weeks of treatment, 3 months
Change from baseline Modified Ashworth Scale at after 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 two weeks of treatment, 3 months
Secondary outcomes (9)
Change from baseline Action Research Arm Test at after treatment and three month
The Action Research Arm Test is used to measure bilateral gross manual and finger dexterity.
Measured: baseline, after two weeks of treatment, 3 months
Change from baseline Box and Block Test at after treatment and three month
The Box and Block Test (BBT) measures unilateral gross manual dexterity.
Measured: baseline, after two weeks of treatment, 3 months
Change from baseline Nine-Hole test at after 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 two weeks of treatment, 3 months
Change from baseline Jebson Taylor Hand Function Test at after 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 two weeks of treatment, 3 months
Change from baseline Functional Independence Measure at after 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 two weeks of treatment, 3 months
Change from baseline Motor Activity Log at after 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 two weeks of treatment, 3 months
Change from baseline Wolf Motor Function Test at after treatment and three month
The Wolf Motor Function Test(WMFT) is used to measure unilateral motor quality and strength.
Measured: baseline, after two weeks of treatment, 3 months
Change from baseline Nottingham Health Profile at after 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 two weeks of treatment, 3 months
Change from baseline Stroke Impact Scale at after 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 two 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 posted22 Sep 2021
- Study start1 Aug 2021
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
- Investigators
- Chia-Ling Chen, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053711
- Sponsor's protocol ID
- 202002582A3
- Status last verified
- Aug 2021
- First submitted
- 3 Sep 2021
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Efficacy of Repetitive Peripheral Magnetic Stimulation on the Repetitive Transcranial Magnetic Stimulation on Upper Limb Function in Patients With Stroke: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05053711
- Acronym / sponsor ID
- 202002582A3
- Conditions
- Stroke
- Keywords
- Repetitive transcranial magnetic stimulation, Repetitive peripheral magnetic stimulation, stroke, novel treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 22 Sep 2021 (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, augmented efficacy of rPMS on the rTMS is employed in this project. This proposal aims at exploring different novel treatment strategies in the treatment of UE dysfunction in patients with stroke: augmented efficacy of rPMS on the rTMS. Several aims in this study include (1) identifying the most optimal treatment protocols for rPMS (TBS treatment and nerve stimulation location), (2 ) establish a novel treatment protocol (augmented efficacy of rPMS on the rTMS), (3) identifying augmented efficacy of rPMS on the rTMS, (4) determining the mechanism of neuro-motor control, and (5) related biomarkers for the novel treatment protocol. The investigators applied a 3-year plan before, however, the Ministry of Science and Technology plan passed one year only (108-2314-B-182-043-). The investigators carried out the pilot study to investigate the augmented effects of rPMS (radial nerve) on the rTMS in the treatment of upper limb function in patients with stroke patients. The previous plan had preliminary results. This year the investigators will apply for a three-year plan to continue the previous pilot study for getting the comprehensive results.
Detailed description
This study intends to further explore whether rPMS intervention in different nerves can augment rTMS efficacy on upper limb function in patients with stroke. A total of 72-96 patients with stroke will be recruited in 2 phases and 36-48 participants will be divided into four groups according to their severity and the onset of stroke, and then randomly enrolled into 3 groups in each phase (12-16 participants in each group) based on different rPMS- stimulated methods and location. All patients will receive the rPMS in addition rTMS on the brain cortex. In phase 1, each patient will receive either one of three rPMS methods on median nerve (iTBS, cTBS, sham). During phase 2, each patient will receive either one of three rPMS methods on ulnar nerve. Outcome measures include clinical assessments based on International Classification of Functioning, Disability and Health (ICF) and motor control (Motor Evoked Potential, MEP, kinetics, and kinematics) that administered at pretest, posttest, and 3-month follow-up. This study aims to establish a novel assessment and treatment protocols in patients with stroke. The intervention will be conducted 10 times for each participant. The optimal effective treatment protocol of augmented efficacy of rPMS on the rTMS 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
- 6
| Arm | Type | Receives |
|---|---|---|
| rTMS+rPMS_iTBS_M | Experimental | Device: rTMS+rPMS_iTBS_MIn this group, they received iTBS on affected hemisphere after following iTBS at median nerve on affected hand. |
| rTMS+rPMS_cTBS_M | Experimental | Device: rTMS+rPMS_cTBS_MIn this group, they received iTBS on affected hemisphere after following cTBS at median nerve on affected hand. |
| rTMS+sham rPMS_M | Sham comparator | Device: rTMS+sham rPMS_MIn this group, they received iTBS on affected hemisphere after following sham TBS stimulation at median nerve on affected hand. |
| rTMS+rPMS_iTBS_U | Experimental | Device: rTMS+rPMS_iTBS_UIn this group, they received iTBS on affected hemisphere after following iTBS at ulnar nerve on affected hand. |
| rTMS+rPMS_cTBS_U | Experimental | Device: rTMS+rPMS_cTBS_UIn this group, they received iTBS on affected hemisphere after following cTBS at ulnar nerve on affected hand. |
| rTMS+sham rPMS_U | Sham comparator | Device: rTMS+sham rPMS_UIn this group, they received iTBS on affected hemisphere after following sham TBS stimulation at ulnar nerve 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_MRepetitive 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 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 |
| rTMS+rPMS_cTBS_MRepetitive 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 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 |
| rTMS+sham rPMS_MRepetitive 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 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 | rTMS+sham rPMS_M |
| rTMS+rPMS_iTBS_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 ulnaris 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_U |
| rTMS+rPMS_cTBS_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 ulnar 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_U |
| rTMS+sham rPMS_URepetitive 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 ulnar nerve 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 | rTMS+sham rPMS_U |
Primary outcome
Change from baseline Motion analysis at after treatment and three month
Time frame: baseline, after two 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 afte treatment and three month
Time frame: baseline, after two 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 treatment and three month
Time frame: baseline, after two weeks of treatment, 3 months
The comparison of baseline of Myoton for stroke after different therapy, assessing the functional status of skeletal muscle, including tone or state of tension(natural oscillation frequency[Hz]), biochanical properties(dynamic stiffness [N/m], logarithmic decrement of natural oscillation), viscoelastic properties(mechanical stress relaxation time [ms], ratio of deformation and relaxation time, characterising Creep (Deborah number)).
Change from baseline Muscle strength at after treatment and three month
Time frame: baseline, after two 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, the strength will be tested by hand dynamometer.
Change from baseline Brunnstrom stage at after treatment and three month
Time frame: baseline, after two 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 treatment and three month
Time frame: baseline, after two 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 treatment and three month
Time frame: baseline, after two 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 treatment and three month
Time frame: baseline, after two weeks of treatment, 3 months
Change from baseline Box and Block Test at after treatment and three month
Time frame: baseline, after two weeks of treatment, 3 months
Change from baseline Nine-Hole test at after treatment and three month
Time frame: baseline, after two weeks of treatment, 3 months
Change from baseline Jebson Taylor Hand Function Test at after treatment and three month
Time frame: baseline, after two weeks of treatment, 3 months
Change from baseline Functional Independence Measure at after treatment and three month
Time frame: baseline, after two weeks of treatment, 3 months
Change from baseline Motor Activity Log at after treatment and three month
Time frame: baseline, after two weeks of treatment, 3 months
Change from baseline Wolf Motor Function Test at after treatment and three month
Time frame: baseline, after two weeks of treatment, 3 months
Change from baseline Nottingham Health Profile at after treatment and three month
Time frame: baseline, after two weeks of treatment, 3 months
Change from baseline Stroke Impact Scale at after treatment and three month
Time frame: baseline, after two 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 17 Aug 2022.
- 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_M, rTMS+rPMS_cTBS_M and rTMS+rPMS_iTBS_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 17 Aug 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 treatment and three month (time frame: baseline, after two 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?
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 17 Aug 2022.