NCT03390192

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 inhibitory rTMS (1Hz) and anodal tDCS (dual-mode stimulation) over bilateral primary motor cortices (M1s) was investigated to compare its modulatory effects with single inhibitory rTMS stimulation in subacute stroke patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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

January 13, 2015

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 25, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 4, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2018

Completed
Last Updated

September 19, 2019

Status Verified

December 1, 2017

Enrollment Period

3.2 years

First QC Date

December 25, 2017

Last Update Submit

September 18, 2019

Conditions

Stroke

Keywords

Noninvasive brain stimulationRepetitive Transcranial Magnetic StimulationTranscranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (1)

  • Fugl-Meyer Assessment score

    Fugl-Meyer Assessment score reflects a motor impairment of a patient. Score range is between 0 and 100.

    2 months post-stimulation

Study Arms (2)

Dual-mode stimulation

EXPERIMENTAL

Dual-mode stimulation is applied over the bilateral primary motor cortex (M1) using active rTMS and active tDCS. 1 Hz of rTMS is applied over the contralesional M1 for 20 minutes with simultaneous application of anodal tDCS on the ipsilesional 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: Dual-mode stimulation

Single sham stimulation

ACTIVE COMPARATOR

Single sham stimulation is applied over the bilateral primary motor cortex (M1) using active rTMS and sham tDCS. 1 Hz of rTMS over the contralesional M1 was applied for 20 minutes with simultaneous application of tDCS with sham mode (no stimulation) on the ipsilesional 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: Single sham stimulation

Interventions

Dual-mode stimulationDEVICE

1Hz rTMS over contralesional primary motor cortex and anodal tDCS over ipsilesional primary motor cortex are simultaneously simulated.

Dual-mode stimulation
Single sham stimulationDEVICE

1Hz rTMS over contralesional primary motor cortex and sham tDCS (no stimulation) over ipsilesional primary motor cortex are simultaneously simulated.

Single sham stimulation

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • Lee J, Lee A, Kim H, Shin M, Yun SM, Jung Y, Chang WH, Kim YH. Different Brain Connectivity between Responders and Nonresponders to Dual-Mode Noninvasive Brain Stimulation over Bilateral Primary Motor Cortices in Stroke Patients. Neural Plast. 2019 Apr 7;2019:3826495. doi: 10.1155/2019/3826495. eCollection 2019.

    PMID: 31093270DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

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
SPONSOR

Study Record Dates

First Submitted

December 25, 2017

First Posted

January 4, 2018

Study Start

January 13, 2015

Primary Completion

March 13, 2018

Study Completion

March 13, 2018

Last Updated

September 19, 2019

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)