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

Not Applicable

• Conditions: Cerebral Vascular Accident
• Interventions: Device: VCT; Device: VCT+optimal rTMS group; Device: iTBS+cTBS group; Device: sham theta burst stimulation; Device: continuous theta burst stimulation; Device: intermittent theta burst stimulation

• Registration Number: NCT03350087
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2016-08
• Study First Submitted: 2017-09-07
• Study First Submitted QC: 2017-11-20
• Study First Posted: 2017-11-22
• Status Verified: 2020-01
• Last Update Submitted: 2020-08-17
• Last Update Posted: 2020-08-18
• Primary Completion: 2022-02-11
• Study Completion: 2022-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VCT group	VCT	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.
VCT+optimal rTMS group	VCT+optimal rTMS group	VCT+optimal rTMS group received the VCT training and optimal rTMS in addition to traditional rehabilitation.
iTBS+cTBS group	iTBS+cTBS group	Continuous theta burst stimulation (cTBS group) at first followed by intermittent theta burst stimulation (iTBS group).
sham TBS group	sham theta burst stimulation	In sham theta burst stimulation (sham TBS group), they received sham TBS stimulation.
cTBS group	continuous theta burst stimulation	In continuous theta burst stimulation (cTBS group), they received cTBS (80% of active motor threshold) on unaffected hemisphere.
iTBS group	intermittent theta burst stimulation	In intermittent theta burst stimulation (iTBS group), they received iTBS (80% of active motor threshold) on affected hemisphere.

Primary Outcome Measures

Name	Time	Method
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
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 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 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))

Secondary Outcome Measures

Name	Time	Method
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 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 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 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 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 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 participation for stroke in after 3 weeks treatment and 3 months follow-up	baseline, after 3 weeks of treatment, 3 months	Nottingham Health Profile

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan