A Study on Brain Activity During Transcranial Direct Current Stimulation in Stroke Patients

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Transcranial direct current simulation

• Registration Number: NCT04549753
• Lead Sponsor: Samsung Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-02
• Study First Submitted QC: 2020-09-08
• Study Start: 2020-09-15
• Study First Posted: 2020-09-16
• Primary Completion: 2020-12-10
• Study Completion: 2020-12-10
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
tDCS stimulation group	Transcranial direct current simulation	Patients receive four sessions of tDCS stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system.

Primary Outcome Measures

Name	Time	Method
Changes in cortical activity using fNIRS signals during brain stimulation	Baseline and about 10 days (immediately after brain stimulation sessions)	Cortical activities before and after brain stimulation sessions are compared.

Secondary Outcome Measures

Name	Time	Method
9-hole pegboard test	Baseline and about 10 days (immediately after brain stimulation sessions)	The test is a standardized, quantitative assessment used to measure finger dexterity of a patient.
Fugl-Meyer Assessment	Baseline and about 10 days (immediately after brain stimulation sessions)	The score is a stroke-specific, performance-based impairment index. The degree of impairment of upper and lower limbs is measured.
Changes in motor evoked potential	Baseline and about 10 days (immediately after brain stimulation sessions)	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.
Grip & Tip pinch strength test	Baseline and about 10 days (immediately after brain stimulation sessions)	The test is to measure the maximum isometric strength of hand, forearm, and finger muscles.
Box & Block test	Baseline and about 10 days (immediately after brain stimulation sessions)	The test is used to measure the gross manual dexterity of a patient, or of a person using an upper limb prosthetic device.
Finger tapping test	Baseline and about 10 days (immediately after brain stimulation sessions)	Response time is measured during finger tapping task.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of