tDCS Response Prediction Using EEG in Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04830631
• Other study ID #: B-2004/608-004
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: March 2024

Study information

• Verified date: May 2022
• Source: Seoul National University Hospital
• Contact: Won-Seok Kim
• Phone: +82317877735
• Email: wondol77[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Motor Recovery
• Rehabilitation
• Stroke
• Transcranial Direct Current Stimulation

Intervention

Device:
• Cathodal transcranial direct current stimulation (tDCS) over the contralesional motor cortex
Cathodal tDCS will be applied to the contralesional motor cortex with 2mA intesntisy for 30 mins/day. Total 10 sessions will be applied.

Locations

Country	Name	City	State
Korea, Republic of	Rusk Rehabilitation Hospital	Seongnam-si	Please Select
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Rusk Rehabilitation Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Fugl-Meyer Assesment Score 1		Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS)
Secondary	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)
Secondary	Changes in Action Research Arm Test Score 1		Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS)
Secondary	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)
Secondary	Changes in Box and Block Test Score 1		Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS)
Secondary	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)
Secondary	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)
Secondary	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)