NCT03635008

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Stroke
• Transcranial Direct Current Stimulation
• Recovery of Function
• Neurological Rehabilitation

Interventions

Type	Name	Description
DEVICE	tDCS	Regard to the anodal tDCS, the anode will be placed over the contralesional premotor area (2.5 cm anterior to the C3 or C4 in 10-20 EEG system) and cathode will be placed over the contralateral supraorbital area. The stimulation intensity will be 2mA. For the sham tDCS the stimulation will be applied for just first 30 seconds.

Timeline

• Start date: 2018-10-15
• Primary completion: 2024-03-15
• Completion: 2024-05-15
• First posted: 2018-08-17
• Last updated: 2022-05-17

Locations

1 site across 1 country: South Korea