Effect of Cerebral and Cerebellar rTMS in Stroke Patient

Stroke Clinical Trial

Official title:

Effect of Cerebral and Cerebellar Repetitive Transcranial Magnetic Stimulation on Motor Function in Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04570774
• Other study ID #: 2020-06-068
• Status: Completed
• Phase: N/A
• Start date: September 2, 2020
• Est. completion date: November 30, 2023

Study information

• Verified date: March 2024
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is based on the characteristics of motor learning theory and motor learning neural network to improve motor function in stroke patients. This study is to investigate whether the cerebral-cerebellar repetitive transcranial magnetic stimulation (rTMS) is effective in improving motor function compared to the conventional cerebral rTMS in stroke patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 30, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Hemiplegic stroke patients within 1 month after onset

• Moderate to severe motor impairment (Fugl-Meyer assessment <85)

• Cognitive and language functions to perform more than one step of command

• More than 19 years old

Exclusion Criteria:

• Contraindicated to rTMS

• Progressive or unstable stroke

• Pre-existing and active major neurological disease or major psychiatric disease

• A history of advanced liver, kidney, cardiac or pulmonary disease, a terminal medical diagnosis consistent with survival <1 year

Related Conditions & MeSH terms

• Motor Recovery
• Repetitive Transcranial Magnetic Stimulation
• rTMS
• Stroke

Intervention

Procedure:
• Repetitive transcranial magnetic stimulation
rTMS over cerebral motor cortex and cerebellar hemisphere

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of upper limb motor score in Fugl-Meyer assessment	(upper limb motor score in Fugl-Meyer assessment at post-intervention) - (upper limb motor score in Fugl-Meyer assessment at baseline); Higher scores mean a better outcome	2 weeks