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

Seoul National University

Status: Enrolling

Conditions: Neurological Rehabilitation; Stroke; Recovery of Function; Transcranial Direct Current Stimulation

Treatments: Device: tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT03635008

B-1805/468-002

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 18-85 years old
• Ischemic or Hemorrhagic stroke confirmed by the MRI or CT
• First-ever stroke
• < 3 months after stroke
• Unilateral upper limb weakness due to the stroke and meets the following all conditions: (1)Shoulder Abduction Finger Extension (SAFE) score (range 0-10) revealing the motor paralysis is below 8 (lower score mean worse function)), (2)Fugl Meyer Assessment score in the affected upper extremity is 25 or under 25. (3)No response in the motor evoked potential recorded on the affected extensor carpi radialis muscle,

Exclusion criteria

• recurrent stroke
• history of the other brain injury (e.g. traumatic brain injury)
• poor cognitive function (score of korean version of mini-mental state exam is 15 or below 15).
• Poor cooperation due to delirium or problems in the consciousness
• Uncontrolled or unstable medical conditions.
• Pregnant
• Scalp problems which interfere with the tDCS application
• Robotic arm training can not be applied due to the unstable sitting posture or head control, or arm pain.
• Metals in the head (e.g. clip, coil)
• Cardiac pacemaker or cochlear implants

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

Anodal tDCS

Experimental group

Description:

This group will receive the 25 mins of the tDCS (Yrain, Korea) over the contralesional premotor area simultaneously with 25 mins of the robotic arm training using Armeo Power (Hocoma, Switzerland), per day. Additional 30 mins of occupational therapy focusing on the arm motor recovery will be provided per day. These interventions will be provided for 10 weekdays. Other conventional rehabilitation (e.g. gait training, speech therapy) will be permitted. 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.

Treatment:

Device: tDCS

sham tDCS

Placebo Comparator group

Description:

This group will receive the 25 mins of the tDCS (Yrain, Korea) over the contralesional premotor area simultaneously with 25 mins of the robotic arm training using Armeo Power (Hocoma, Switzerland), per day. Additional 30 mins of occupational therapy focusing on the arm motor recovery will be provided per day. These interventions will be provided for 10 weekdays. Other conventional rehabilitation (e.g. gait training, speech therapy) will be permitted. Regard to the sham 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 started but the intensity will decrease and stop in 30 seconds.

Treatment:

Device: tDCS