Repetitive Transcranial Magnetic Stimulation in Patients With Hemiplegic Stroke
1 other identifier
interventional
48
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Apr 2013
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 10, 2013
CompletedFirst Posted
Study publicly available on registry
May 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2039
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2040
February 4, 2025
February 1, 2025
26.7 years
May 10, 2013
February 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Keyboard tapping test
Participants will be asked to tap a key of a computer keyboard as fast as possible in five seconds. They will be asked to do three times. We will measure the number of tapping. The primary outcome will be the averaged data of the numbers.This will be done before and after 5-day rTMS intervention.
1 day
Study Arms (3)
Tradtional Theta burst stimulation (TBS) rTMS
EXPERIMENTALParticipants will receive continuous theta burst stimulation (cTBS) rTMS to contralesional hemisphere based on a previous study (Huang et al., 2005)
Modified TBS rTMS
ACTIVE COMPARATORParticipants will receive modified cTBS rTMS to contralesional hemisphere based on a previous study (Nyffeler et al., 2006)
Sham rTMS
SHAM COMPARATORParticipants will receive sham cTBS rTMS to contralesional hemisphere.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, 445-170, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
May 10, 2013
First Posted
May 16, 2013
Study Start
April 1, 2013
Primary Completion (Estimated)
December 1, 2039
Study Completion (Estimated)
December 1, 2040
Last Updated
February 4, 2025
Record last verified: 2025-02