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Efficacy of rTMS and VCT on Upper Limb Function in Patients With Stroke

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ClinicalTrials.gov Identifier: NCT03350087
Recruitment Status : Recruiting
First Posted : November 22, 2017
Last Update Posted : May 14, 2018
Sponsor:
Collaborator:
Ministry of Science and Technology, Taiwan
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief 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 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).

Condition or disease Intervention/treatment Phase
Cerebral Vascular Accident Device: intermittent theta burst stimulation Device: continuous theta burst stimulation Device: iTBS+cTBS group Device: sham theta burst stimulation Device: VCT Device: VCT+optimal rTMS group Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Repetitive Transcranial Magnetic Stimulation and Virtual Cycling Training on Upper Limb Function in Patients With Stroke
Actual Study Start Date : August 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : November 2019

Arm Intervention/treatment
Experimental: iTBS group
In intermittent theta burst stimulation (iTBS group), they received iTBS (80% of active motor threshold) on affected hemisphere.
Device: intermittent theta burst stimulation

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


Experimental: cTBS group
In continuous theta burst stimulation (cTBS group), they received cTBS (80% of active motor threshold) on unaffected hemisphere.
Device: continuous theta burst stimulation

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


Experimental: iTBS+cTBS group
Continuous theta burst stimulation (cTBS group) at first followed by intermittent theta burst stimulation (iTBS group).
Device: iTBS+cTBS group
In iTBS+cTBS pattern, continuous cTBS will be followed by intermittent iTBS (low pulse; 1200 pulses in total)

Sham Comparator: sham TBS group
In sham theta burst stimulation (sham TBS group), they received sham TBS stimulation.
Device: sham theta burst stimulation

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


Experimental: VCT group
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.
Device: VCT

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


Experimental: VCT+optimal rTMS group
VCT+optimal rTMS group received the VCT training and optimal rTMS in addition to traditional rehabilitation.
Device: VCT+optimal rTMS group
In VCT+optimal rTMS group, VCT will be combined with optimal rTMS, which has the best outcome in phase 1.




Primary Outcome Measures :
  1. 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

  2. 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))

  3. 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

  4. 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


Secondary Outcome Measures :
  1. 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 ]
    InBodyS10 Body Composition Analyzer

  2. 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 ]
    Barthel Index

  3. 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 ]
    Adaptive behavior assessment system

  4. 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 ]
    Stroke Impact Scale

  5. 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 ]
    Wolf motor function test

  6. 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 ]
    Motor activity log

  7. 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 ]
    Timed 'Up & Go' test

  8. 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 ]
    Functional Independence Measure

  9. 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 ]
    Nottingham Health Profile



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • brain stem or cerebellum stroke
  • epilepsy
  • aneurysm
  • arteriovenous malformation
  • psychiatric disease
  • degenerative disease
  • severe cognitive and communicative impairment or aphasia
  • severe medical disease
  • active medical problems
  • metal implant in the body
  • pregnancy
  • poor cooperation with assessments

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03350087


Contacts
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Contact: Chia-Ling Chen, MD, PhD +886-3-3281200 ext 8148 clingchen@gmail.com

Locations
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Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Contact: Chia-Ling Chen, MD, PhD    +886-3-3281200 ext 8147    clingchen@gmail.com   
Principal Investigator: Chia-Ling Chen, MD, PhD         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Ministry of Science and Technology, Taiwan
Investigators
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Study Director: Chia-Ling Chen, MD, PhD Chang Gung Memorial Hospital

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03350087     History of Changes
Other Study ID Numbers: 104-8816A3
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chang Gung Memorial Hospital:
repetitive transcranial magnetic stimulation
stroke
optimal treatment protocol
VR-based cycling training (VCT)
randomized controlled trial
motor control
clinical predictors

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases