tDCS Response Prediction Using EEG in Stroke

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04830631
• Collaborator: Rusk Rehabilitation Hospital (Other)
• Enrollment: 100
• Locations: 2
• Anticipated Duration (Months): 44
• Patients Per Site: 50
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Rehabilitation; Transcranial Direct Current Stimulation; Motor Recovery	Device: Cathodal transcranial direct current stimulation (tDCS) over the contralesional motor cortex

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prediction of Transcranial Direct Current Stimulation (tDCS) Responses Using Electroencephalography (EEG )in Patients With Chronic Stroke
• Actual Study Start Date: Jul 1, 2020
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Mar 1, 2024

Outcome Measures

Primary Outcome Measures

1. Changes in Fugl-Meyer Assesment Score 1 [Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS)]

Secondary Outcome Measures

1. 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)]

2. Changes in Action Research Arm Test Score 1 [Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS)]

3. 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)]

4. Changes in Box and Block Test Score 1 [Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS)]

5. 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)]

6. 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.

7. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do	Korea, Republic of	13620
2	Rusk Rehabilitation Hospital	Seongnam-si	Please Select	Korea, Republic of	13620

Sponsors and Collaborators

• Seoul National University Hospital
• Rusk Rehabilitation Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Won-Seok Kim, Associate professor, Seoul National University Bundang Hospital
• ClinicalTrials.gov Identifier: NCT04830631
• Other Study ID Numbers: B-2004/608-004
• First Posted: Apr 5, 2021
• Last Update Posted: May 17, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of May 17, 2022