Cerebral Vascular AccidentNCT03350087
Efficacy of rTMS and VCT on Upper Limb Function in Patients With Stroke
A study testing intermittent theta burst stimulation, continuous theta burst stimulation and iTBS+cTBS group in people with Cerebral Vascular Accident, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Stroke is the major cause of motor impairment and physical disabilities in the adult population. Spasticity and loss of dexterity are the common problems in stroke. Recently, current interventions, such as cycling training, virtual reality (VR) and repetitive transcranial magnetic stimulation (rTMS), were used for the… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Cerebral Vascular Accident
- What is being tested?
- intermittent theta burst stimulation, continuous theta burst stimulation and iTBS+cTBS group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2016to 31 May 2022
- 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 stroke
- chronic stroke (onset > 3 months)
- unilateral cerebral lesion with hemiparesis or hemiplegia
- age of 20-80 years
- no epileptic spikes on the EEG
Who cannot join
- brain stem or cerebellum stroke
- epilepsy
- aneurysm
- arteriovenous malformation
- psychiatric disease
- degenerative disease
Show all 12Show fewer
- severe cognitive and communicative impairment or aphasia
- severe medical disease
- active medical problems
- metal implant in the body
- pregnancy
- poor cooperation with assessments
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial 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 Repetitive Transcranial Magnetic Stimulation and Virtual Cycling Training on Upper Limb Function in Patients With Stroke
Stroke is the major cause of motor impairment and physical disabilities in the adult population. Spasticity and loss of dexterity are the common problems in stroke. Recently, current interventions, such as cycling training, virtual reality (VR) and repetitive transcranial magnetic stimulation (rTMS), were used for the treatment of upper extremity (UE) dysfunction in patients with stroke. However, few studies investigated the effects of the combinations of different treatment strategies using by integrating brain imaging and motor control studies. This project proposes different novel treatment strategies in the treatment of UE dysfunction in patients with stroke: combined inhibitory/facilitatory rTMS, VR-based cycling training (VCT), and combined rTMS and VCT. We hypothesize that the treatment effect of the combined protocol (optimal rTMS protocol and VCT) is more effective than single treatment due to integration of central and peripheral effects. Different treatment protocols will induce different changes in the brain reorganization and motor control, which further improve motor function, activity, participation, and health related quality of life (HRQOL).
Read the detailed description
This study aims to 1. identify the immediate effects of different treatment protocols in for UE training in these patients through brain image, motor control and clinical measures; 2. to determine the maintaining therapeutic effects; 3. to elucidate the most optimal treatment protocols; 4. to determine the neuro-motor control mechanism underlying clinical improvement; 5. to determine the clinimetric properties of the brain imaging and motor control measure that are responsive and valid for detecting changes after treatment protocol intervention, and 6. to identify clinical predictors influencing the outcome for treatment protocols.
The research will offer valuable motor control biomarkers for outcome prediction and targeting patients who benefit from new protocols. This project is significant for the translational and evidence-based medicine on stroke neurorehabilitation.
- Conditions
- Cerebral Vascular Accident
- Being tested
- intermittent theta burst stimulation, continuous theta burst stimulation, iTBS+cTBS group, sham theta burst stimulation, VCT
- Keywords
- repetitive transcranial magnetic stimulation, stroke, optimal treatment protocol, VR-based cycling training (VCT), randomized controlled trial, motor control, clinical predictors
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent theta burst stimulationDevice
In intermittent theta burst stimulation pattern (iTBS) will intermittently give a 2 s train of TBS every 10s repeated 2 times for a total of 40 times (low pulse: 1200 pulses in total)
Other Names:
intermittent theta burst stimulation
continuous theta burst stimulationDevice
In 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(low pulse: 1200 pulses in total).
Other Names:
continuous burst stimulation
iTBS+cTBS groupDevice
In iTBS+cTBS pattern, continuous cTBS will be followed by intermittent iTBS (low pulse; 1200 pulses in total)
sham theta burst stimulationDevice
In sham burst stimulation pattern (sham TBS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds(almost no pulse: 1200 pulses in total).
Other Names:
sham theta burst stimulation
VCTDevice
The UE VCT programs were conducted three times per week, for 12 weeks. Each UE VCT session involved upper limb cycling training followed by UE training in addition to home program. The cycling program consisted of a warm-up exercise, twenty repetitions of hand push-up movements in the sitting position, UE cycling, and a cool-down exercise. The warm-up and cool-down exercises involved stretching and relaxing the head, neck, and the upper and lower body.
Other Names:
The upper extremity programs virtual cycling training program
VCT+optimal rTMS groupDevice
In VCT+optimal rTMS group, VCT will be combined with optimal rTMS, which has the best outcome in phase 1.
| Study group | Role | What they receive |
|---|---|---|
| iTBS group | Experimental | In intermittent theta burst stimulation (iTBS group), they received iTBS (80% of active motor threshold) on affected hemisphere. Receives: Device: intermittent theta burst stimulation |
| cTBS group | Experimental | In continuous theta burst stimulation (cTBS group), they received cTBS (80% of active motor threshold) on unaffected hemisphere. Receives: Device: continuous theta burst stimulation |
| iTBS+cTBS group | Experimental | Continuous theta burst stimulation (cTBS group) at first followed by intermittent theta burst stimulation (iTBS group). Receives: Device: iTBS+cTBS group |
| sham TBS group | Sham comparator | In sham theta burst stimulation (sham TBS group), they received sham TBS stimulation. Receives: Device: sham theta burst stimulation |
| VCT group | Experimental | VCT group received the VCT training in addition to traditional rehabilitation. Each UE VCT session involved upper limb cycling training followed by UE training in addition to home program. The cycling program consisted of a warm-up exercise, twenty repetitions of hand push-up movements in the sitting position, UE cycling, and a cool-down exercise. Receives: Device: VCT |
| VCT+optimal rTMS group | Experimental | VCT+optimal rTMS group received the VCT training and optimal rTMS in addition to traditional rehabilitation. Receives: Device: VCT+optimal rTMS group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of mechanical measurement for stroke after 3 weeks treatment and 3 months follow-up
Kinematic analysis for upper limb
Measured: baseline, after 3 weeks of treatment, 3 months
Change from baseline of severity for stroke after 3 weeks treatment and 3 months follow-up
Brunnstrom stage classification(by severity from stage 1 to stage 6), Modified Ashworth Scale (tension of upper limb from min(0) to max (4)) and National Institute of Health Stroke Scale (severity from min(0) to max(4))
Measured: baseline, after 3 weeks of treatment, 3 months
Change from baseline of Muscle tone measurement for stroke after 3 weeks treatment and 3 months follow-up
Muscle tone
Measured: baseline, after 3 weeks of treatment, 3 months
Change from baseline of Muscle strength measurement for stroke after 3 weeks treatment and 3 months follow-up
Muscle strength
Measured: baseline, after 3 weeks of treatment, 3 months
Secondary outcomes (9)
Change from baseline of body composition for stroke in after 3 weeks treatment and 3 months follow-up
InBodyS10 Body Composition Analyzer
Measured: baseline, after 3 weeks of treatment, 3 months
Change from baseline of activity for stroke in after 3 weeks treatment and 3 months follow-up
Barthel Index
Measured: baseline, after 3 weeks of treatment, 3 months
Change from baseline of ABAS for stroke in after 3 weeks treatment and 3 months follow-up
Adaptive behavior assessment system
Measured: baseline, after 3 weeks of treatment, 3 months
Change from baseline of quality of life for stroke in after 3 weeks treatment and 3 months follow-up
Stroke Impact Scale
Measured: baseline, after 3 weeks of treatment, 3 months
Change from baseline of WMFT for stroke in after 3 weeks treatment and 3 months follow-up
Wolf motor function test
Measured: baseline, after 3 weeks of treatment, 3 months
Change from baseline of MAL for stroke in after 3 weeks treatment and 3 months follow-up
Motor activity log
Measured: baseline, after 3 weeks of treatment, 3 months
Change from baseline of TUG for stroke in after 3 weeks treatment and 3 months follow-up
Timed 'Up \& Go' test
Measured: baseline, after 3 weeks of treatment, 3 months
Change from baseline of FIM for stroke in after 3 weeks treatment and 3 months follow-up
Functional Independence Measure
Measured: baseline, after 3 weeks of treatment, 3 months
Change from baseline of participation for stroke in after 3 weeks treatment and 3 months follow-up
Nottingham Health Profile
Measured: baseline, after 3 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 Nov 2017
- Study startAug 2016
- Primary completion11 Feb 2022 (estimated)
- Study completion31 May 2022 (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 Cerebral Vascular AccidentStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 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, MD, PhD, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350087
- Sponsor's protocol ID
- 104-8816A3
- Status last verified
- Jan 2020
- First submitted
- 7 Sep 2017
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen YH, Chen CL, Huang YZ, Chen HC, Chen CY, Wu CY, Lin KC. Augmented efficacy of intermittent theta burst stimulation on the virtual reality-based cycling training for upper limb function in patients with stroke: a double-blinded, randomized controlled trial. J Neuroeng Rehabil. 2021 May 31;18(1):91. doi: 10.1186/s12984-021-00885-5.
PubMed 34059090
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Repetitive Transcranial Magnetic Stimulation and Virtual Cycling Training on Upper Limb Function in Patients With Stroke
- ClinicalTrials.gov ID
- NCT03350087
- Acronym / sponsor ID
- 104-8816A3
- Conditions
- Cerebral Vascular Accident
- Keywords
- repetitive transcranial magnetic stimulation, stroke, optimal treatment protocol, VR-based cycling training (VCT), randomized controlled trial, motor control, clinical predictors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- Aug 2016 (actual)
- Primary completion
- 11 Feb 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 22 Nov 2017 (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.
Stroke is the major cause of motor impairment and physical disabilities in the adult population. Spasticity and loss of dexterity are the common problems in stroke. Recently, current interventions, such as cycling training, virtual reality (VR) and repetitive transcranial magnetic stimulation (rTMS), were used for the treatment of upper extremity (UE) dysfunction in patients with stroke. However, few studies investigated the effects of the combinations of different treatment strategies using by integrating brain imaging and motor control studies. This project proposes different novel treatment strategies in the treatment of UE dysfunction in patients with stroke: combined inhibitory/facilitatory rTMS, VR-based cycling training (VCT), and combined rTMS and VCT. We hypothesize that the treatment effect of the combined protocol (optimal rTMS protocol and VCT) is more effective than single treatment due to integration of central and peripheral effects. Different treatment protocols will induce different changes in the brain reorganization and motor control, which further improve motor function, activity, participation, and health related quality of life (HRQOL).
Detailed description
This study aims to 1. identify the immediate effects of different treatment protocols in for UE training in these patients through brain image, motor control and clinical measures; 2. to determine the maintaining therapeutic effects; 3. to elucidate the most optimal treatment protocols; 4. to determine the neuro-motor control mechanism underlying clinical improvement; 5. to determine the clinimetric properties of the brain imaging and motor control measure that are responsive and valid for detecting changes after treatment protocol intervention, and 6. to identify clinical predictors influencing the outcome for treatment protocols.
The research will offer valuable motor control biomarkers for outcome prediction and targeting patients who benefit from new protocols. This project is significant for the translational and evidence-based medicine on stroke neurorehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| iTBS group | Experimental | Device: intermittent theta burst stimulationIn intermittent theta burst stimulation (iTBS group), they received iTBS (80% of active motor threshold) on affected hemisphere. |
| cTBS group | Experimental | Device: continuous theta burst stimulationIn continuous theta burst stimulation (cTBS group), they received cTBS (80% of active motor threshold) on unaffected hemisphere. |
| iTBS+cTBS group | Experimental | Device: iTBS+cTBS groupContinuous theta burst stimulation (cTBS group) at first followed by intermittent theta burst stimulation (iTBS group). |
| sham TBS group | Sham comparator | Device: sham theta burst stimulationIn sham theta burst stimulation (sham TBS group), they received sham TBS stimulation. |
| VCT group | Experimental | Device: VCTVCT group received the VCT training in addition to traditional rehabilitation. Each UE VCT session involved upper limb cycling training followed by UE training in addition to home program. The cycling program consisted of a warm-up exercise, twenty repetitions of hand push-up movements in the sitting position, UE cycling, and a cool-down exercise. |
| VCT+optimal rTMS group | Experimental | Device: VCT+optimal rTMS groupVCT+optimal rTMS group received the VCT training and optimal rTMS in addition to traditional rehabilitation. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- first stroke
- chronic stroke (onset > 3 months)
- unilateral cerebral lesion with hemiparesis or hemiplegia
- age of 20-80 years
- no epileptic spikes on the EEG
Key exclusion criteria (12 listed)
- brain stem or cerebellum stroke
- epilepsy
- aneurysm
- arteriovenous malformation
- psychiatric disease
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 |
|---|---|---|
| intermittent theta burst stimulationIn intermittent theta burst stimulation pattern (iTBS) will intermittently give a 2 s train of TBS every 10s repeated 2 times for a total of 40 times (low pulse: 1200 pulses in total) Other Names: intermittent theta burst stimulation | Device | iTBS group |
| continuous theta burst stimulationIn 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(low pulse: 1200 pulses in total). Other Names: continuous burst stimulation | Device | cTBS group |
| iTBS+cTBS groupIn iTBS+cTBS pattern, continuous cTBS will be followed by intermittent iTBS (low pulse; 1200 pulses in total) | Device | iTBS+cTBS group |
| sham theta burst stimulationIn sham burst stimulation pattern (sham TBS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds(almost no pulse: 1200 pulses in total). Other Names: sham theta burst stimulation | Device | sham TBS group |
| VCTThe UE VCT programs were conducted three times per week, for 12 weeks. Each UE VCT session involved upper limb cycling training followed by UE training in addition to home program. The cycling program consisted of a warm-up exercise, twenty repetitions of hand push-up movements in the sitting position, UE cycling, and a cool-down exercise. The warm-up and cool-down exercises involved stretching and relaxing the head, neck, and the upper and lower body. Other Names: The upper extremity programs virtual cycling training program | Device | VCT group |
| VCT+optimal rTMS groupIn VCT+optimal rTMS group, VCT will be combined with optimal rTMS, which has the best outcome in phase 1. | Device | VCT+optimal rTMS group |
Primary outcome
Change from baseline of mechanical measurement for stroke after 3 weeks treatment and 3 months follow-up
Time frame: baseline, after 3 weeks of treatment, 3 months
Kinematic analysis for upper limb
Change from baseline of severity for stroke after 3 weeks treatment and 3 months follow-up
Time frame: baseline, after 3 weeks of treatment, 3 months
Brunnstrom stage classification(by severity from stage 1 to stage 6), Modified Ashworth Scale (tension of upper limb from min(0) to max (4)) and National Institute of Health Stroke Scale (severity from min(0) to max(4))
Change from baseline of Muscle tone measurement for stroke after 3 weeks treatment and 3 months follow-up
Time frame: baseline, after 3 weeks of treatment, 3 months
Muscle tone
Change from baseline of Muscle strength measurement for stroke after 3 weeks treatment and 3 months follow-up
Time frame: baseline, after 3 weeks of treatment, 3 months
Muscle strength
9 secondary outcomes
Change from baseline of body composition for stroke in after 3 weeks treatment and 3 months follow-up
Time frame: baseline, after 3 weeks of treatment, 3 months
Change from baseline of activity for stroke in after 3 weeks treatment and 3 months follow-up
Time frame: baseline, after 3 weeks of treatment, 3 months
Change from baseline of ABAS for stroke in after 3 weeks treatment and 3 months follow-up
Time frame: baseline, after 3 weeks of treatment, 3 months
Change from baseline of quality of life for stroke in after 3 weeks treatment and 3 months follow-up
Time frame: baseline, after 3 weeks of treatment, 3 months
Change from baseline of WMFT for stroke in after 3 weeks treatment and 3 months follow-up
Time frame: baseline, after 3 weeks of treatment, 3 months
Change from baseline of MAL for stroke in after 3 weeks treatment and 3 months follow-up
Time frame: baseline, after 3 weeks of treatment, 3 months
Change from baseline of TUG for stroke in after 3 weeks treatment and 3 months follow-up
Time frame: baseline, after 3 weeks of treatment, 3 months
Change from baseline of FIM for stroke in after 3 weeks treatment and 3 months follow-up
Time frame: baseline, after 3 weeks of treatment, 3 months
Change from baseline of participation for stroke in after 3 weeks treatment and 3 months follow-up
Time frame: baseline, after 3 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 18 Aug 2020.
- Derived from this study: PubMed 34059090Chen YH, Chen CL, Huang YZ, Chen HC, Chen CY, Wu CY, Lin KC. Augmented efficacy of intermittent theta burst stimulation on the virtual reality-based cycling training for upper limb function in patients with stroke: a double-blinded, randomized controlled trial. J Neuroeng Rehabil. 2021 May 31;18(1):91. doi: 10.1186/s12984-021-00885-5.
- Individual participant dataSharing planned: No
Related trials for Cerebral Vascular Accident
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
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, MD, PhD 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 intermittent theta burst stimulation, continuous theta burst stimulation and iTBS+cTBS group in people with Cerebral Vascular Accident, 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 5 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 18 Aug 2020. 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 of mechanical measurement for stroke after 3 weeks treatment and 3 months follow-up (time frame: baseline, after 3 weeks of treatment, 3 months). The study lists 4 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 NCT03350087, 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 18 Aug 2020.