Cerebral Vascular AccidentNCT01947413
New Protocols in the Treatment of Upper Limb Dysfunctions of Patients With Stroke.
A study testing intermittent theta burst stimulation and continuous theta burst stimulation in people with Cerebral Vascular Accident, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The fundamental goals of early rehabilitation for patients with stroke are: optimizing motor function within each patient's prognostic potential, preventing the development of secondary conditions that impact life-long health, and promoting patient's participation in their lives. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Vascular Accident
- What is being tested?
- intermittent theta burst stimulation and continuous theta burst stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2012to Jun 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 20-80 y/o
- patients with 1st onset cerebral stroke.
Who cannot join
- Brain stem or cerebellar stroke
- Contraindication to MRI, such as metallic implant
- Contraindication to BoNTA, such as poor controlled epilepsy
- History of psychiatric disease
- Received BoNTA injection or surgery in recent six months
- Severe psychological impairments, such as mental retardation, autism, or severe Communication problems
- Progressive disorders, such as neurodegenerative disease
- Active medical disease, such as infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: New Protocols in the Treatment of Upper Limb Dysfunctions of Patients With Stroke: An Evidence of Clinical and Kinematic Studies.
The fundamental goals of early rehabilitation for patients with stroke are: optimizing motor function within each patient's prognostic potential, preventing the development of secondary conditions that impact life-long health, and promoting patient's participation in their lives. In addition to employ clinical measures after treatment, usual outcome measures employed in the intervention studies included movement kinematics (spatio-temporal characteristics of movements). Recent reports have suggested repetitive transcranial magnetic stimulation (rTMS) and BoNTA (BoNTA) improved motor function in patients with stroke. A novel rTMS paradigm, theta burst stimulation (TBS), including intermittent TBS (iTBS) and continuous TBS (cTBS), that modulates human cortical excitability differently. However, there is lack of literatures in verifying the treatment effect by the integration of clinical and kinematic analysis. Until now, there are no conclusive results regarding optimal rTMS protocol, such as stimulating pattern and for patients with stroke. Additionally, few studies investigate the possible clinical characteristics of patients with stroke that may influence the effects of various treatment protocols proposed in this project.
Read the detailed description
The research program aims at studying patients with stroke the immediate and maintaining effects of new upper-extremity (UE) treatment protocols after brain damage and identifying the possible mechanisms underlying treatment-induced changes in patients with stroke. This research will study new treatment approaches that have been formulated based on principles of integrated central modulation (rTMS) and peripheral modification techniques (BoNTA).
- To compare the movement functions and motor control in patients with stroke of different motor severities.
- To investigate the immediate and maintaining effects of different protocols in the treatment of upper limb functions.
- To evaluate motor control and clinical outcomes after different treatment approaches applied in the UE training of patients with stroke. The treatment approaches to be studied will include different protocols. We hypothesize that there will be improvements in movement performance after the treatment and the level of post-treatment performance will differ among the treatments through different reorganization patterns. 3.1 To compare the motor control and clinical outcomes after different treatment approaches. 3.2 To identify the optimal treatment protocol for patients with stroke.
- To investigate the possible predictors of treatment outcome associated with motor severity, movement and participation for each type of treatments. The possible predictors will include brain lesions, and severity. We hypothesize that the proposed prognostic factors will predict treatment outcomes.
- To analyze the association between motor reorganization measured by kinematic study and behavioral improvement in motor severity, movement and participation measured by clinical tools.
Treating motor dysfunction in patients with stroke requires an understanding of the mechanism underlying motor control. Recent reports have suggested BoNTA and rTMS improved motor function in patients with various disorders. However, there are few researches in identifying the optimal rTMS protocol in the treatment of upper limb dysfunctions in patients with stroke. There is lack of literatures in verifying the treatment effect by movement control studies. The current research will offer valuable kinematic data that support neural-motor models proposed to account for motor control problems in these patients. More important, we will identify the new protocol in the treatment of upper limb dysfunctions in patients with stroke through integration of clinical and kinematic measures. We will identify clinical predictors influencing the outcome for different treatment approaches, and analyze the association between motor control and clinical measures involving motor severity, movement and participation. We believe the results of this study will refine services and supports for patients with stroke to meet these goals. This study may potentially provide directions in kinematic measures for future studies on patients with stroke.
- Conditions
- Cerebral Vascular Accident
- Being tested
- intermittent theta burst stimulation, continuous theta burst stimulation, sham theta burst stimulation
- Keywords
- repetitive transcranial magnetic stimulation, BoNTA, stroke, optimal treatment protocol, 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 stimulationOther
In intermittent theta burst stimulation pattern (iTBS) will intermittently give a 2 s train of TBS every 10s for a total of 20 times (low pulse: 600 pulses in total)
continuous theta burst stimulationOther
Also called continuous burst stimulation
In continuous burst stimulation pattern (cTBS) will intermittently give a cTBS treatment consists of a continuous train of TBS for 40 seconds(low pulse: 600 pulses in total).
sham theta burst stimulationOther
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: 600 pulses in total).
| 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: Other: 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: Other: continuous theta burst stimulation |
| sham TBS group | Sham comparator | In sham theta burst stimulation (sham TBS group), they received sham TBS stimulation. Receives: Other: sham theta burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of Kinematic analysis after 2 weeks treatment and 3 months , 12 months follow up.
Kinematic analysis for upper limb analysis.
Measured: baseline, after treatment, 3 months , 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startDec 2012
- Primary completionJun 2017
- Study completionJun 2017
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.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Ling Chen, PhD, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947413
- Sponsor's protocol ID
- 100-0012A3
- Status last verified
- Sep 2016
- First submitted
- 18 Sep 2013
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Chen YJ, Huang YZ, Chen CY, Chen CL, Chen HC, Wu CY, Lin KC, Chang TL. Intermittent theta burst stimulation enhances upper limb motor function in patients with chronic stroke: a pilot randomized controlled trial. BMC Neurol. 2019 Apr 25;19(1):69. doi: 10.1186/s12883-019-1302-x.
PubMed 31023258
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Protocols in the Treatment of Upper Limb Dysfunctions of Patients With Stroke: An Evidence of Clinical and Kinematic Studies.
- ClinicalTrials.gov ID
- NCT01947413
- Acronym / sponsor ID
- 100-0012A3
- Conditions
- Cerebral Vascular Accident
- Keywords
- repetitive transcranial magnetic stimulation, BoNTA, stroke, optimal treatment protocol, randomized controlled trial, motor control, clinical predictors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 20 Sep 2013 (estimated)
- 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.
The fundamental goals of early rehabilitation for patients with stroke are: optimizing motor function within each patient's prognostic potential, preventing the development of secondary conditions that impact life-long health, and promoting patient's participation in their lives. In addition to employ clinical measures after treatment, usual outcome measures employed in the intervention studies included movement kinematics (spatio-temporal characteristics of movements). Recent reports have suggested repetitive transcranial magnetic stimulation (rTMS) and BoNTA (BoNTA) improved motor function in patients with stroke. A novel rTMS paradigm, theta burst stimulation (TBS), including intermittent TBS (iTBS) and continuous TBS (cTBS), that modulates human cortical excitability differently. However, there is lack of literatures in verifying the treatment effect by the integration of clinical and kinematic analysis. Until now, there are no conclusive results regarding optimal rTMS protocol, such as stimulating pattern and for patients with stroke. Additionally, few studies investigate the possible clinical characteristics of patients with stroke that may influence the effects of various treatment protocols proposed in this project.
Detailed description
The research program aims at studying patients with stroke the immediate and maintaining effects of new upper-extremity (UE) treatment protocols after brain damage and identifying the possible mechanisms underlying treatment-induced changes in patients with stroke. This research will study new treatment approaches that have been formulated based on principles of integrated central modulation (rTMS) and peripheral modification techniques (BoNTA).
- To compare the movement functions and motor control in patients with stroke of different motor severities.
- To investigate the immediate and maintaining effects of different protocols in the treatment of upper limb functions.
- To evaluate motor control and clinical outcomes after different treatment approaches applied in the UE training of patients with stroke. The treatment approaches to be studied will include different protocols. We hypothesize that there will be improvements in movement performance after the treatment and the level of post-treatment performance will differ among the treatments through different reorganization patterns. 3.1 To compare the motor control and clinical outcomes after different treatment approaches. 3.2 To identify the optimal treatment protocol for patients with stroke.
- To investigate the possible predictors of treatment outcome associated with motor severity, movement and participation for each type of treatments. The possible predictors will include brain lesions, and severity. We hypothesize that the proposed prognostic factors will predict treatment outcomes.
- To analyze the association between motor reorganization measured by kinematic study and behavioral improvement in motor severity, movement and participation measured by clinical tools.
Treating motor dysfunction in patients with stroke requires an understanding of the mechanism underlying motor control. Recent reports have suggested BoNTA and rTMS improved motor function in patients with various disorders. However, there are few researches in identifying the optimal rTMS protocol in the treatment of upper limb dysfunctions in patients with stroke. There is lack of literatures in verifying the treatment effect by movement control studies. The current research will offer valuable kinematic data that support neural-motor models proposed to account for motor control problems in these patients. More important, we will identify the new protocol in the treatment of upper limb dysfunctions in patients with stroke through integration of clinical and kinematic measures. We will identify clinical predictors influencing the outcome for different treatment approaches, and analyze the association between motor control and clinical measures involving motor severity, movement and participation. We believe the results of this study will refine services and supports for patients with stroke to meet these goals. This study may potentially provide directions in kinematic measures for future studies on patients with stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| iTBS group | Experimental | Other: intermittent theta burst stimulationIn intermittent theta burst stimulation (iTBS group), they received iTBS (80% of active motor threshold) on affected hemisphere. |
| cTBS group | Experimental | Other: continuous theta burst stimulationIn continuous theta burst stimulation (cTBS group), they received cTBS (80% of active motor threshold) on unaffected hemisphere. |
| sham TBS group | Sham comparator | Other: sham theta burst stimulationIn sham theta burst stimulation (sham TBS group), they received sham TBS stimulation. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: 20-80 y/o
- patients with 1st onset cerebral stroke.
Key exclusion criteria (8 listed)
- Brain stem or cerebellar stroke
- Contraindication to MRI, such as metallic implant
- Contraindication to BoNTA, such as poor controlled epilepsy
- History of psychiatric disease
- Received BoNTA injection or surgery in recent six months
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 for a total of 20 times (low pulse: 600 pulses in total) | Other | iTBS group |
| continuous theta burst stimulationAlso: continuous burst stimulationIn continuous burst stimulation pattern (cTBS) will intermittently give a cTBS treatment consists of a continuous train of TBS for 40 seconds(low pulse: 600 pulses in total). | Other | 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: 600 pulses in total). | Other | sham TBS group |
Primary outcome
Change from baseline of Kinematic analysis after 2 weeks treatment and 3 months , 12 months follow up.
Time frame: baseline, after treatment, 3 months , 6 months
Kinematic analysis for upper limb analysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- Derived from this study: PubMed 31023258Chen YJ, Huang YZ, Chen CY, Chen CL, Chen HC, Wu CY, Lin KC, Chang TL. Intermittent theta burst stimulation enhances upper limb motor function in patients with chronic stroke: a pilot randomized controlled trial. BMC Neurol. 2019 Apr 25;19(1):69. doi: 10.1186/s12883-019-1302-x.
- 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, 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 and continuous theta burst stimulation 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 11 Sep 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of Kinematic analysis after 2 weeks treatment and 3 months , 12 months follow up. (time frame: baseline, after treatment, 3 months , 6 months). 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 NCT01947413, 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 11 Sep 2017.