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

NCT03635008 | Unknown

• 1 other identifier: B-1805/468-002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment (FMA) scores of the upper extremity

  range: 0 (worst) -66 (best)

  Change from Baseline FMA at 2 weeks

Secondary Outcomes (13)

• Korean version of modified Barthel Index (K-MBI)

  Change from baseline K-MBI at 2 weeks

• Korean version of modified Barthel Index (K-MBI)

  Change from baseline K-MBI at 6 weeks

• Brunnstrom stage (B-stage) of arm

  Change from baseline B-stage at 2 weeks

• Brunnstrom stage (B-stage) of arm

  Change from baseline B-stage at 6 weeks

• Box and Block Test (BBT)

  Change from baseline BBT at 2 weeks

Study Arms (2)

Anodal tDCS

EXPERIMENTAL

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

sham tDCS

PLACEBO COMPARATOR

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

Interventions

tDCS DEVICE

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.

Anodal tDCS; sham tDCS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• the Ministry of Trade, Industry & Energy(MOTIE, Korea), Ybrain (Korea): collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Please Select, 13620, South Korea

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Won-Seok Kim, MD, PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Won-Seok Kim, MD, PhD

CONTACT

+82317877735; wondol77@gmail.com

Jihong Park, MD

CONTACT

wpeo00@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An investigator who applies the tDCS to the participants will not be masked. However, other investigators including outcome assessors and participants will be masked. The other care providers in our department (e.g. other physio- or occupational therapists) will be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized, double-blind, sham-controlled, parallel group design

Study Record Dates

• First Submitted: July 14, 2018
• First Posted: August 17, 2018
• Study Start: October 15, 2018
• Primary Completion: March 15, 2024
• Study Completion: May 15, 2024
• Last Updated: May 17, 2022

Record last verified: 2022-05

Locations

KR (1)