New Protocols in the Treatment of Upper Limb Dysfunctions of Patients With Stroke.
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 18, 2013
CompletedFirst Posted
Study publicly available on registry
September 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedSeptember 11, 2017
September 1, 2016
4.5 years
September 18, 2013
September 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline of Kinematic analysis after 2 weeks treatment and 3 months , 12 months follow up.
Kinematic analysis for upper limb analysis.
baseline, after treatment, 3 months , 6 months
Study Arms (3)
iTBS group
EXPERIMENTALIn intermittent theta burst stimulation (iTBS group), they received iTBS (80% of active motor threshold) on affected hemisphere.
cTBS group
EXPERIMENTALIn continuous theta burst stimulation (cTBS group), they received cTBS (80% of active motor threshold) on unaffected hemisphere.
sham TBS group
SHAM COMPARATORIn sham theta burst stimulation (sham TBS group), they received sham TBS stimulation.
Interventions
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)
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).
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).
Eligibility Criteria
You may qualify if:
- Age: 20-80 y/o
- patients with 1st onset cerebral stroke.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chang Gung Memorial Hospital
Taoyuan District, 333, Taiwan
Related Publications (1)
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.
PMID: 31023258DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chia-Ling Chen, PhD
Chang Gung Memorial Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2013
First Posted
September 20, 2013
Study Start
December 1, 2012
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
September 11, 2017
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share