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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Neurological Rehabilitation; Transcranial Direct Current Stimulation; Recovery of Function
• Intervention / Treatment: Device: tDCS

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Won-Seok Kim, MD, PhD; Phone Number: +82317877735; Email: wondol77@gmail.com
• Study Contact Backup: Name: Jihong Park, MD; Email: wpeo00@gmail.com

Study Locations

• Korea, Republic of
  • Please Select
    • Seongnam-si, Please Select, Korea, Republic of, 13620
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: Won-Seok Kim, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anodal tDCS; 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.	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.
Placebo Comparator: sham tDCS; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Assessment (FMA) scores of the upper extremity	range: 0 (worst) -66 (best)	Change from Baseline FMA at 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Korean version of modified Barthel Index (K-MBI)	range: 0 (worst) -100 (best)	Change from baseline K-MBI at 2 weeks
Korean version of modified Barthel Index (K-MBI)	range: 0 (worst) -100 (best)	Change from baseline K-MBI at 6 weeks
Brunnstrom stage (B-stage) of arm	range: 1(worst) -6 (best)	Change from baseline B-stage at 2 weeks
Brunnstrom stage (B-stage) of arm	range: 1(worst) -6 (best)	Change from baseline B-stage at 6 weeks
Box and Block Test (BBT)	maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds, more numbers mean better function	Change from baseline BBT at 2 weeks
Box and Block Test (BBT)	maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds, more numbers mean better function	Change from baseline BBT at 6 weeks
Modified Ashworth Scale	to measure the spasticity: 6 grades: 0 (no spasticity), 1, 1+, 2, 3, 4 (severe spasticity)	2 weeks after baseline
Modified Ashworth Scale	to measure the spasticity: 6 grades: 0 (no spasticity), 1, 1+, 2, 3, 4 (severe spasticity)	6 weeks after baseline
Manual muscle power test	3 proximal (shoulder abduction, elbow flexion, and extension) and 5 distal (flexion and extension of the hand and fingers, and thumb flexion) muscle groups, 6 grades ranges from 0 (flaccid) to 5 (strongest).	2 weeks after baseline
Manual muscle power test	3 proximal (shoulder abduction, elbow flexion, and extension) and 5 distal (flexion and extension of the hand and fingers, and thumb flexion) muscle groups, 6 grades ranges from 0 (flaccid) to 5 (strongest).	6 weeks after baseline
Laterality Index	Ratio of the cortical activation between the contra- and ipsilesional motor area recorded by the electroencephalography	2 weeks after baseline
Laterality Index	Ratio of the cortical activation between the contra- and ipsilesional motor area recorded by the electroencephalography	6 weeks after baseline
Fugl-Meyer Assessment (FMA) scores of the upper extremity	range: 0 (worst) -66 (best)	Change from Baseline FMA at 6 weeks

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: the Ministry of Trade, Industry & Energy(MOTIE, Korea), Ybrain (Korea)
• Investigators: Principal Investigator: Won-Seok Kim, MD, PhD, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Anticipated): March 15, 2024
• Study Completion (Anticipated): May 15, 2024

Study Registration Dates

• First Submitted: July 14, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 15, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: B-1805/468-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: We are not planning to share the individual data publicly. However, if other researchers interested in our project, they can contact PI by email and we can discuss further for the sharing. If data sharing is decided after the discussion with other researchers, we will consider sharing after the review of the appropriateness by our institutional review board.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No