tDCS Response Prediction Using EEG in Stroke

Prediction of Transcranial Direct Current Stimulation (tDCS) Responses Using Electroencephalography (EEG )in Patients With Chronic Stroke

Patients with chronic stroke (>6 months after stroke) having unilateral upper limb hemiparesis will be recruited. Patients will maintain their usual inpatient rehabilitation including occupational therapy. At baseline (T0) and after 2weeks of enrollment (T1), Fugl-Meyer assessment (FMA) will be assessed at each time. And patients with the changes of FMA between T0 and T1 less than 3 points will be finally recruited. The enrolled patients will receive additional 30-min cathodal transcranial direct current stimulation (tDCS) over the contralesional motor cortex for 10 consecutive weekdays, with maintaining their usual conventional rehabilitation. At T1 and immediately after 10-seessions of tDCS (T2) and 1 month after completing 10-tDCS session (T3), FMA, Actional Research Arm Test (ARAT), Box and Block Test (BBT) and electroencephalography (EEG) were measured.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Rehabilitation; Transcranial Direct Current Stimulation; Motor Recovery
• Intervention / Treatment: Device: Cathodal transcranial direct current stimulation (tDCS) over the contralesional motor cortex

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Won-Seok Kim; Phone Number: +82317877735; Email: wondol77@gmail.com

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: Won-Seok Kim; Phone Number: 0317877735; Email: wondol77@gmail.com
      • Principal Investigator: Won-Seok Kim, MD
  • Please Select
    • Seongnam-si, Please Select, Korea, Republic of, 13620
      • Recruiting
      • Rusk Rehabilitation Hospital
      • Contact: Chaiyoung Lim, MD
      • Principal Investigator: Chaiyoung Lim, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chronic stroke patients with unilateral hemiparesis

Description

Inclusion Criteria:

• age ranges from 19 to 85 yrs old
• stroke patients with unilateral hemiparesis
• 1st ever stroke
• chronic stroke (>6 months after stroke)

Exclusion Criteria:

• recurrent stroke
• history of traumatic brain injury
• Minimental state examination score is 15 or less.
• Unstable medical conditions
• Severe delirium, disorders of consciousness
• pregnancy
• can not attach tDCS electrode on the scalp due to skin conditions
• can not maintain the sitting position
• intracranial metals

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in Fugl-Meyer Assesment Score 1	Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Fugl-Meyer Assesment Score 2		Between T2 (immediately after completing 10 sessions of tDCS) and T3 (1 month after completing 10 sessions of tDCS)
Changes in Action Research Arm Test Score 1		Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS)
Changes in Action Research Arm Test Score 2		Between T2 (immediately after completing 10 sessions of tDCS) and T3 (1 month after completing 10 sessions of tDCS)
Changes in Box and Block Test Score 1		Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS)
Changes in Box and Block Test Score 2		Between T2 (immediately after completing 10 sessions of tDCS) and T3 (1 month after completing 10 sessions of tDCS)
Changes in EEG index1	Various kinds of EEG indexe.g., network indexes, event-related dysynchronization, mu suppression) will be surveyed.	Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS)
Changes in EEG index 2	Various kinds of EEG indexe.g., network indexes, event-related dysynchronization, mu suppression) will be surveyed.	Between T2 (immediately after completing 10 sessions of tDCS) and T3 (1 month after completing 10 sessions of tDCS)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Rusk Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 5, 2021

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-2004/608-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: After completing the study, EEG indexes and behavioral outcomes will be considered to be shared with researchers who have the clear and reasonable purpose to use our data.

Drug and device information, study documents

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