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

Cerebral Vascular Accident Clinical Trial

Official title:

Efficacy of Repetitive Transcranial Magnetic Stimulation and Virtual Cycling Training on Upper Limb Function in Patients With Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03350087
• Other study ID #: 104-8816A3
• Status: Recruiting
• Phase: N/A
• Start date: August 2016
• Est. completion date: May 31, 2022

Study information

• Verified date: January 2020
• Source: Chang Gung Memorial Hospital
• Contact: Chia-Ling Chen, MD, PhD
• Phone: +886-3-3281200
• Email: clingchen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 31, 2022
• Est. primary completion date: February 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Vascular Accident
• Stroke

Intervention

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
• 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
• iTBS+cTBS group
In iTBS+cTBS pattern, continuous cTBS will be followed by intermittent iTBS (low pulse; 1200 pulses in total)
• 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
• 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
• VCT+optimal rTMS group
In VCT+optimal rTMS group, VCT will be combined with optimal rTMS, which has the best outcome in phase 1.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of mechanical measurement for stroke after 3 weeks treatment and 3 months follow-up	Kinematic analysis for upper limb	baseline, after 3 weeks of treatment, 3 months
Primary	Change from baseline of severity for stroke after 3 weeks treatment and 3 months follow-up	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))	baseline, after 3 weeks of treatment, 3 months
Primary	Change from baseline of Muscle tone measurement for stroke after 3 weeks treatment and 3 months follow-up	Muscle tone	baseline, after 3 weeks of treatment, 3 months
Primary	Change from baseline of Muscle strength measurement for stroke after 3 weeks treatment and 3 months follow-up	Muscle strength	baseline, after 3 weeks of treatment, 3 months
Secondary	Change from baseline of body composition for stroke in after 3 weeks treatment and 3 months follow-up	InBodyS10 Body Composition Analyzer	baseline, after 3 weeks of treatment, 3 months
Secondary	Change from baseline of activity for stroke in after 3 weeks treatment and 3 months follow-up	Barthel Index	baseline, after 3 weeks of treatment, 3 months
Secondary	Change from baseline of ABAS for stroke in after 3 weeks treatment and 3 months follow-up	Adaptive behavior assessment system	baseline, after 3 weeks of treatment, 3 months
Secondary	Change from baseline of quality of life for stroke in after 3 weeks treatment and 3 months follow-up	Stroke Impact Scale	baseline, after 3 weeks of treatment, 3 months
Secondary	Change from baseline of WMFT for stroke in after 3 weeks treatment and 3 months follow-up	Wolf motor function test	baseline, after 3 weeks of treatment, 3 months
Secondary	Change from baseline of MAL for stroke in after 3 weeks treatment and 3 months follow-up	Motor activity log	baseline, after 3 weeks of treatment, 3 months
Secondary	Change from baseline of TUG for stroke in after 3 weeks treatment and 3 months follow-up	Timed 'Up & Go' test	baseline, after 3 weeks of treatment, 3 months
Secondary	Change from baseline of FIM for stroke in after 3 weeks treatment and 3 months follow-up	Functional Independence Measure	baseline, after 3 weeks of treatment, 3 months
Secondary	Change from baseline of participation for stroke in after 3 weeks treatment and 3 months follow-up	Nottingham Health Profile	baseline, after 3 weeks of treatment, 3 months