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Recruiting NCT01855633

Repetitive Transcranial Magnetic Stimulation in Patients With Hemiplegic Stroke

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Traditional Theta burst stimulation (TBS), Modified TBS rTMS, Sham rTMS.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Device Traditional Theta burst stimulation (TBS)
  • Device Modified TBS rTMS
  • Device Sham rTMS

Primary outcome measures

  • Keyboard tapping test [Time frame: 1 day]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Dongtan Sacred Heart Hospital — Hwaseong-si

Identifiers

NCT: NCT01855633 · 2013-019

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗