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

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03350087

Collaborator

Ministry of Science and Technology, Taiwan (Other)

120

Enrollment

Location

Arms

69.9

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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 :

Aug 1, 2016

Anticipated Primary Completion Date :

Feb 11, 2022

Anticipated Study Completion Date :

May 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Change from baseline of mechanical measurement for stroke after 3 weeks treatment and 3 months follow-up [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 [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 [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 [baseline, after 3 weeks of treatment, 3 months]
Muscle strength

Secondary Outcome Measures

Change from baseline of body composition for stroke in after 3 weeks treatment and 3 months follow-up [baseline, after 3 weeks of treatment, 3 months]
InBodyS10 Body Composition Analyzer
Change from baseline of activity for stroke in after 3 weeks treatment and 3 months follow-up [baseline, after 3 weeks of treatment, 3 months]
Barthel Index
Change from baseline of ABAS for stroke in after 3 weeks treatment and 3 months follow-up [baseline, after 3 weeks of treatment, 3 months]
Adaptive behavior assessment system
Change from baseline of quality of life for stroke in after 3 weeks treatment and 3 months follow-up [baseline, after 3 weeks of treatment, 3 months]
Stroke Impact Scale
Change from baseline of WMFT for stroke in after 3 weeks treatment and 3 months follow-up [baseline, after 3 weeks of treatment, 3 months]
Wolf motor function test
Change from baseline of MAL for stroke in after 3 weeks treatment and 3 months follow-up [baseline, after 3 weeks of treatment, 3 months]
Motor activity log
Change from baseline of TUG for stroke in after 3 weeks treatment and 3 months follow-up [baseline, after 3 weeks of treatment, 3 months]
Timed 'Up & Go' test
Change from baseline of FIM for stroke in after 3 weeks treatment and 3 months follow-up [baseline, after 3 weeks of treatment, 3 months]
Functional Independence Measure
Change from baseline of participation for stroke in after 3 weeks treatment and 3 months follow-up [baseline, after 3 weeks of treatment, 3 months]
Nottingham Health Profile