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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04549753
Other study ID # 2020-04-183
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2020
Est. completion date December 10, 2020

Study information

Verified date September 2020
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to identify the characteristics of neural plasticity seen in stroke patients by measuring the changes in brain activity during stimulation using functional near-infrared spectroscopy (fNIRS) when applying transcranial direct current stimulation (tDCS) for the purpose of enhancing finger function.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 10, 2020
Est. primary completion date December 10, 2020
Accepts healthy volunteers No
Gender All
Age group 19 Years to 80 Years
Eligibility Inclusion Criteria: - Unilateral stroke patients - Chronic patients over 6 months after onset - Subcortical stroke - Patients with the movement of fingers Exclusion Criteria: - History of psychiatric disease - Significant other neurological diseases except for stroke - Difficult to perform this experiment - Patients with metal implants - History of epilepsy - Pregnancy - Skin defect at the site of electrode attachment

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Transcranial direct current simulation
Four sessions of stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in cortical activity using fNIRS signals during brain stimulation Cortical activities before and after brain stimulation sessions are compared. Baseline and about 10 days (immediately after brain stimulation sessions)
Secondary Changes in motor evoked potential Resting motor threshold (rMT) and amplitude of motor evoked potential in first dorsal interosseous muscle are measured. These outcomes are measured by transcranial magnetic stimulation over the motor hotspot. The rMT is defined as the minimum stimulus intensity that produced a minimal motor evoked response at rest. The amplitude means peak to peak of the muscle response. Baseline and about 10 days (immediately after brain stimulation sessions)
Secondary 9-hole pegboard test The test is a standardized, quantitative assessment used to measure finger dexterity of a patient. Baseline and about 10 days (immediately after brain stimulation sessions)
Secondary Grip & Tip pinch strength test The test is to measure the maximum isometric strength of hand, forearm, and finger muscles. Baseline and about 10 days (immediately after brain stimulation sessions)
Secondary Box & Block test The test is used to measure the gross manual dexterity of a patient, or of a person using an upper limb prosthetic device. Baseline and about 10 days (immediately after brain stimulation sessions)
Secondary Fugl-Meyer Assessment The score is a stroke-specific, performance-based impairment index. The degree of impairment of upper and lower limbs is measured. Baseline and about 10 days (immediately after brain stimulation sessions)
Secondary Finger tapping test Response time is measured during finger tapping task. Baseline and about 10 days (immediately after brain stimulation sessions)
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