ClinicalTrials.gg
CompletedNCT03279640Updated Sep 14, 2017

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

An interventional study of rTMS on ipsilesional M1 and tDCS on contralesional M1 in Stroke and Motor Disorder, sponsored by Samsung Medical Center. Completed. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-14.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 6 months after the study started (first participant enrolled Mar 2014, registered Sep 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 46 studies in Stroke by Samsung Medical Center — 1 open to participants now, 2 under way, none of them phase 3. Stroke · Samsung Medical Center.

Enrollment
24th of 31
24 · median 32
Started
2014
the only one that year
No phase
29 of 46
1 open now
Registered
16th of 46
by date

Among the 46 studies in Stroke by Samsung Medical Center, this one is the 24th largest by enrollment of the 31 interventional ones that give a count, is the only one that started in 2014, is one of 29 with no phase, and was the 16th registered.

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

Browse Stroke studies →

Open to participants now

1 of the 46 studies in Stroke by Samsung Medical Center is open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

Where they have run

Who these studies take

Of the 1,415 Stroke studies recruiting now, 697 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.

This study: 19 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 46 studies in Stroke by Samsung Medical Center, or all of them as a file.
02

Study 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.

Read the detailed 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.

03

Conditions studied

  • Stroke
  • Motor Disorder

Keywords

  • Motor Network
  • Resting-state fMRI
  • Repetitive Transcranial Magnetic Stimulation
  • Transcranial Direct Current Stimulation
04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Major active neurological disease or psychiatric disease
  • A history of seizure
  • Metallic implants in their brain
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Dual-mode stimulation

    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

  • Experimental
    Single stimulation

    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

  • DevicerTMS on ipsilesional M1
  • DevicetDCS on contralesional M1
06

What researchers measure

Primary outcomes

  1. Neuroimaging Assessment

    Resting-state fMRI

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 29666636 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2014 to primary completion in Feb 2017, 35 months.

Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 35 months is above that.

Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 10, 2017
First posted
Sep 12, 2017
StartActual
Mar 1, 2014
Primary completionActual
Feb 28, 2017
CompletionActual
Feb 28, 2017
Last update
Sep 14, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03279640
Responsible party
Sponsor
First posted
Sep 12, 2017
Start date
Mar 1, 2014
Primary completion
Feb 28, 2017
Completion
Feb 28, 2017
Last update
Sep 14, 2017

Study contacts

Yun-Hee Kim, MD, PhD
principal investigator · Samsung Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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