Effects of Brain Network by Simultaneous Dual-mode Stimulation in Subacute Stroke Patients

Stroke Clinical Trial

Official title:

Investigation for Individualized Noninvasive Neuromodulation in Neurorehabilitation of Brain Disease: Longitudinal Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03279640
• Other study ID #: 2013-06-002
• Status: Completed
• Phase: N/A
• First received: September 10, 2017
• Last updated: September 12, 2017
• Start date: March 1, 2014
• Est. completion date: February 28, 2017

Study information

• Verified date: June 2017
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) has been used for the modulation of stroke patients' motor function by altering the cortical excitability. Recently, more challenging approaches, such as stimulation of two or more sites or use of dual modality have been studied in stroke patients. In this study, simultaneous stimulation using both rTMS and tDCS (dual-mode stimulation) over bilateral primary motor cortices (M1s) was investigated to compare its modulatory effects with single rTMS stimulation in subacute stroke patients.

Description:

Investigators assessed each patient's motor function using the Fugl-Meyer Assessment (FMA) score and acquired their resting-state fMRI (rs-fMRI) data at two times: prior to stimulation and 2 months after stimulation. Changes in rs-fMRI network measures were investigated between groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 28, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• First-ever stroke patients

• Subacute stage (less than 4 weeks)

• Total Fugl-Meyer Assessment (FMA) score under 84

Exclusion Criteria:

• Major active neurological disease or psychiatric disease

• A history of seizure

• Metallic implants in their brain

Related Conditions & MeSH terms

• Motor Disorder
• Motor Disorders
• Stroke

Intervention

Device:
• rTMS on ipsilesional M1

• tDCS on contralesional M1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuroimaging Assessment	Resting-state fMRI	Change from baseline resting-state brain network at 8 weeks after intervention