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

NCT03279640 | Completed

• 1 other identifier: 2013-06-002
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stroke; Motor Disorder

Keywords

Motor Network; Resting-state fMRI; Repetitive Transcranial Magnetic Stimulation; Transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (1)

• Neuroimaging Assessment

  Resting-state fMRI

  Change from baseline resting-state brain network at 8 weeks after intervention

Study Arms (2)

Dual-mode stimulation

EXPERIMENTAL

rTMS on ipsilesional M1 + tDCS on contralesional M1 10 Hz of rTMS was applied over the ipsilesional M1 for 20 minutes with simultaneous application of cathodal tDCS on the contralesional M1. Each participant's total FMA score is assessed and their resting-state fMRI data at two times: prior to stimulation (pre-stimulation) and 2 months after stimulation (post-stimulation) are acquired.

Device: rTMS on ipsilesional M1; Device: tDCS on contralesional M1

Single stimulation

EXPERIMENTAL

rTMS on ipsilesional M1 10 Hz of rTMS over the ipsilesional M1 was applied for 20 minutes. Each participant's total FMA score is assessed and their resting-state fMRI data at two times: prior to stimulation (pre-stimulation) and 2 months after stimulation (post-stimulation) are acquired.

Device: rTMS on ipsilesional M1

Interventions

rTMS on ipsilesional M1 DEVICE

Dual-mode stimulation; Single stimulation

tDCS on contralesional M1 DEVICE

Dual-mode stimulation

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First-ever stroke patients
• Subacute stage (less than 4 weeks)
• Total Fugl-Meyer Assessment (FMA) score under 84

You may not qualify if:

• Major active neurological disease or psychiatric disease
• A history of seizure
• Metallic implants in their brain

Sponsors & Collaborators

• Samsung Medical Center: lead

Related Publications (1)

• Lee J, Park E, Lee A, Chang WH, Kim DS, Shin YI, Kim YH. Modulating Brain Connectivity by Simultaneous Dual-Mode Stimulation over Bilateral Primary Motor Cortices in Subacute Stroke Patients. Neural Plast. 2018 Feb 13;2018:1458061. doi: 10.1155/2018/1458061. eCollection 2018.

  PMID: 29666636 DERIVED

MeSH Terms

Conditions

Stroke; Motor Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders

Study Officials

• Yun-Hee Kim, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2017
• First Posted: September 12, 2017
• Study Start: March 1, 2014
• Primary Completion: February 28, 2017
• Study Completion: February 28, 2017
• Last Updated: September 14, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share