Repetitive Transcranial Magnetic Stimulation in Patients With Hemiplegic Stroke

Dongtan Sacred Heart Hospital

Status: Enrolling

Conditions: Stroke

Treatments: Device: Traditional Theta burst stimulation (TBS); Device: Modified TBS rTMS; Device: Sham rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT01855633

2013-019

Details and patient eligibility

About

Stroke is one of the major causes of death in the World. Many stroke survivors may suffer from long-term sequelae of stroke such as hemiplegia. The effects of rehabilitation therapy are limited. The development of new treatment strategies is essential. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive method to stimulate the focal area of the brain for restoring brain function. The aim of this study is to investigate the therapeutic effect of rTMS on the motor recovery in patients with hemiplegic stroke.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• stroke patients with motor weakness
• Medical research council (MRC) grade 0-4
• More than 2 weeks after stroke onset
• Age 18 years and older
• Able to provide consent for the protocol

Exclusion criteria

• History of previous symptomatic stroke
• pregnant women
• Persons with surgically or traumatically implanted foreign bodies such as a pacemaker, an implanted medication pump, a metal plate in the skull, or metal inside the skull or eyes (other than dental appliances or fillings), intracardiac lines that may pose a physical hazard during magnetic stimulation will also be excluded
• Patients with history of seizure disorder or epilepsy
• Subjects without the capacity to give informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 3 patient groups

Tradtional Theta burst stimulation (TBS) rTMS

Experimental group

Description:

Participants will receive continuous theta burst stimulation (cTBS) rTMS to contralesional hemisphere based on a previous study (Huang et al., 2005)

Treatment:

Device: Traditional Theta burst stimulation (TBS)

Modified TBS rTMS

Active Comparator group

Description:

Participants will receive modified cTBS rTMS to contralesional hemisphere based on a previous study (Nyffeler et al., 2006)

Treatment:

Device: Modified TBS rTMS

Sham rTMS

Sham Comparator group

Description:

Participants will receive sham cTBS rTMS to contralesional hemisphere.

Treatment:

Device: Sham rTMS