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NCT03635008

Anodal Transcranial Direct Current Stimulation Over the Contralesional Hemisphere on Motor Recovery in Subacute Stroke Patients

Status unknown NA Last updated 17 May 2022
What this trial tests

NA trial testing tDCS in Stroke in 36 participants. Status unknown.

Timeline
15 October 2018
Primary endpoint
15 March 2024
15 May 2024

Quick facts

Lead sponsorSeoul National University Hospital
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment36
Start date15 October 2018
Primary completion15 March 2024
Estimated completion15 May 2024
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Seoul National University Hospital

Who can join

Adults 18 to 85, any sex, with Stroke or Transcranial Direct Current Stimulation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Upper limb recovery is not predicted by the initial severity of paralysis and the parameters reflecting the integrity of the corticospinal tract (e.g. motor evoked potential, fractional anisotropy in diffusion tensor imaging). Although the inhibition of the contralesional hemisphere is known to be beneficial for the upper limb recovery after stroke in previous studies, this is not proven in the severely paralyzed upper limb. And the studies using the noninvasive stimulation in subacute stroke is lack. In addition, the role of contralesional (unaffected) hemisphere is known to be playing the important role in severe stroke. In this randomized, double-blind, sham-controlled studies, the patients with subacute stroke (\<3 months after stroke onset), severe paralysis of the upper limb with poor prognosis (poor motor score and no response of motor evoked potential recorded in the extensor carpi radialis muscle) will be recruited. Interventional group will receive the 25 mins of anodal transcranial direct current stimulation (tDCS) over the contralesional premotor area plus 25 mins of robotic arm training per session for 10 sessions in 2 weeks. Control group will receive the same treatment except for sham tDCS instead of anodal tDCS over the contralesional premotor area. Functional outcome will be measured before and after the intervention (baseline, immediately after the intervention and 1 month after the intervention). Cortical activation pattern will be measured by the electroencephalography (EEG) at baseline and immediately after the intervention.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Effects of anodal transcranial direct current stimulation over the contralesional hemisphere on motor recovery in subacute stroke patients with severe upper extremity hemiparesis: Study protocol for a randomized controlled trial.
    Lee SH, Kim WS, Park J, Kim J, et al · · 2020 · cited 7× · PMID 32243365 · DOI 10.1097/md.0000000000019495

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Other trials of tDCS

Trials testing the same drug.

Other recruiting trials for Stroke

Currently open trials in the same condition.

Other Seoul National University Hospital trials

Trials by the same sponsor.

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