New Protocols in the Treatment of Upper Limb Dysfunctions of Patients With Stroke.
Primary Purpose
Cerebral Vascular Accident
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
intermittent theta burst stimulation
continuous theta burst stimulation
sham theta burst stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Vascular Accident focused on measuring repetitive transcranial magnetic stimulation, BoNTA, stroke, optimal treatment protocol, randomized controlled trial, motor control, clinical predictors
Eligibility Criteria
Inclusion Criteria:
- Age: 20-80 y/o
- patients with 1st onset cerebral stroke.
Exclusion Criteria:
- 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
Sites / Locations
- Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
iTBS group
cTBS group
sham TBS group
Arm Description
In intermittent theta burst stimulation (iTBS group), they received iTBS (80% of active motor threshold) on affected hemisphere.
In continuous theta burst stimulation (cTBS group), they received cTBS (80% of active motor threshold) on unaffected hemisphere.
In sham theta burst stimulation (sham TBS group), they received sham TBS stimulation.
Outcomes
Primary Outcome Measures
Change from baseline of Kinematic analysis after 2 weeks treatment and 3 months , 12 months follow up.
Kinematic analysis for upper limb analysis.
Secondary Outcome Measures
Full Information
NCT ID
NCT01947413
First Posted
September 18, 2013
Last Updated
September 7, 2017
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01947413
Brief Title
New Protocols in the Treatment of Upper Limb Dysfunctions of Patients With Stroke.
Official Title
New Protocols in the Treatment of Upper Limb Dysfunctions of Patients With Stroke: An Evidence of Clinical and Kinematic Studies.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Vascular Accident
Keywords
repetitive transcranial magnetic stimulation, BoNTA, stroke, optimal treatment protocol, randomized controlled trial, motor control, clinical predictors
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iTBS group
Arm Type
Experimental
Arm Description
In intermittent theta burst stimulation (iTBS group), they received iTBS (80% of active motor threshold) on affected hemisphere.
Arm Title
cTBS group
Arm Type
Experimental
Arm Description
In continuous theta burst stimulation (cTBS group), they received cTBS (80% of active motor threshold) on unaffected hemisphere.
Arm Title
sham TBS group
Arm Type
Sham Comparator
Arm Description
In sham theta burst stimulation (sham TBS group), they received sham TBS stimulation.
Intervention Type
Other
Intervention Name(s)
intermittent theta burst stimulation
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
continuous theta burst stimulation
Other Intervention Name(s)
continuous burst stimulation
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
sham theta burst stimulation
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change from baseline of Kinematic analysis after 2 weeks treatment and 3 months , 12 months follow up.
Description
Kinematic analysis for upper limb analysis.
Time Frame
baseline, after treatment, 3 months , 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age: 20-80 y/o
patients with 1st onset cerebral stroke.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-Ling Chen, PhD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31023258
Citation
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.
Results Reference
derived
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New Protocols in the Treatment of Upper Limb Dysfunctions of Patients With Stroke.
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