Individualized Brain Stimulation Using Transcranial Direct Current Stimulation Simulation in Stroke Patients

Stroke Clinical Trial

Official title:

Individualized Brain Stimulation Using Transcranial Direct Current Stimulation Simulation in Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04699331
• Other study ID #: 2019-07-107
• Status: Completed
• Phase: N/A
• Start date: January 29, 2021
• Est. completion date: December 23, 2022

Study information

• Verified date: February 2023
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to investigate the effect of transcranial direct current stimulation (tDCS) simulation-based individualized stimulation compared to conventional stimulation and sham stimulation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 23, 2022
• Est. primary completion date: December 23, 2022
• 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

• Patients with motor evoked potential of the first dorsal interosseous muscle

• 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 who are deemed difficult to participate in this research by the investigator

• Patients with metal implants and medical devices

• History of epilepsy

• Pregnancy

• Skin defect at the site of electrode attachment

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Transcranial Direct Current Stimulation
Transcranial direct current stimulation is a form of noninvasive neuromodulation that uses constant and low direct current delivered via electrodes on the scalp.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in motor evoked potential	Resting motor threshold (rMT), amplitude, and latency of motor evoked potential in the 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. The latency is defined as the time point from the onset of the stimulus to the onset of MEP.	Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
Secondary	Jebsen-Taylor hand function test	This test is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL).	Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
Secondary	9-hole peg test	The test is a standardized, quantitative assessment used to measure finger dexterity of a patient.	Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five 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, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five 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, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five 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, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
Secondary	Sequential motor test	Response time and accuracy are measured during finger tapping task.	Baseline, 1 day (immediately after one brain stimulation session), 5 days (immediately before and after three brain stimulation sessions), and about 14 days (immediately before and after five brain stimulation sessions)