Clinical trial NCT04830631: tDCS Response Prediction Using EEG in Stroke
Official title: Prediction of Transcranial Direct Current Stimulation (tDCS) Responses Using Electroencephalography (EEG )in Patients With Chronic Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Rehabilitation
Transcranial Direct Current Stimulation
Motor Recovery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Rusk Rehabilitation Hospital
First posted: 2021-04-05
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic stroke patients with unilateral hemiparesis

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in Fugl-Meyer Assesment Score 1
timeFrame: Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS)
Secondary outcomes:
measure: Changes in Fugl-Meyer Assesment Score 2
timeFrame: Between T2 (immediately after completing 10 sessions of tDCS) and T3 (1 month after completing 10 sessions of tDCS)
measure: Changes in Action Research Arm Test Score 1
timeFrame: Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS)
measure: Changes in Action Research Arm Test Score 2
timeFrame: Between T2 (immediately after completing 10 sessions of tDCS) and T3 (1 month after completing 10 sessions of tDCS)
measure: Changes in Box and Block Test Score 1
timeFrame: Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS)
measure: Changes in Box and Block Test Score 2
timeFrame: Between T2 (immediately after completing 10 sessions of tDCS) and T3 (1 month after completing 10 sessions of tDCS)
measure: Changes in EEG index1
timeFrame: Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS)
measure: Changes in EEG index 2
timeFrame: Between T2 (immediately after completing 10 sessions of tDCS) and T3 (1 month after completing 10 sessions of tDCS)
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Rusk Rehabilitation Hospital
state: Please Select
Study officials:
References: