tDCS Response Prediction Using EEG in Stroke

• Conditions: Stroke; Transcranial Direct Current Stimulation; Rehabilitation; Motor Recovery

• Registration Number: NCT04830631
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2021-03-31
• Study First Submitted QC: 2021-03-31
• Study First Posted: 2021-04-05
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-15
• Last Update Posted: 2022-05-17
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 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 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 EEG index1	Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS)	Various kinds of EEG indexe.g., network indexes, event-related dysynchronization, mu suppression) will be surveyed.
Changes in EEG index 2	Between T2 (immediately after completing 10 sessions of tDCS) and T3 (1 month after completing 10 sessions of tDCS)	Various kinds of EEG indexe.g., network indexes, event-related dysynchronization, mu suppression) will be surveyed.

Trial Locations

Locations (2)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of

Rusk Rehabilitation Hospital; 🇰🇷 Seongnam-si, Please Select, Korea, Republic of