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

Chang Gung Medical Foundation

Status: Unknown

Conditions: Cerebral Vascular Accident

Treatments: Device: iTBS+cTBS group; Device: VCT+optimal rTMS group; Device: sham theta burst stimulation; Device: VCT; Device: continuous theta burst stimulation; Device: intermittent theta burst stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03350087

104-8816A3

Details and patient eligibility

About

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).

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 6 patient groups

iTBS group

Experimental group

Description:

In intermittent theta burst stimulation (iTBS group), they received iTBS (80% of active motor threshold) on affected hemisphere.

Treatment:

Device: intermittent theta burst stimulation

cTBS group

Experimental group

Description:

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

Treatment:

Device: continuous theta burst stimulation

iTBS+cTBS group

Experimental group

Description:

Continuous theta burst stimulation (cTBS group) at first followed by intermittent theta burst stimulation (iTBS group).

Treatment:

Device: iTBS+cTBS group

sham TBS group

Sham Comparator group

Description:

In sham theta burst stimulation (sham TBS group), they received sham TBS stimulation.

Treatment:

Device: sham theta burst stimulation

VCT group

Experimental group

Description:

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.

Treatment:

Device: VCT

VCT+optimal rTMS group

Experimental group

Description:

VCT+optimal rTMS group received the VCT training and optimal rTMS in addition to traditional rehabilitation.

Treatment:

Device: VCT+optimal rTMS group