The Effect of tDCS on Motor Learning and Neural Network in Stroke Patients

Stroke Clinical Trial

Official title:

Investigation of Compensational Mechanism and Effect of Transcranial Direct Stimulation on Motor Learning Through Neural Network Analysis in Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04903457
• Other study ID #: 2021-04-075
• Status: Completed
• Phase: N/A
• Start date: June 17, 2021
• Est. completion date: December 31, 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 on motor learning to stroke patients compared to sham stimulation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 31, 2022
• Est. primary completion date: June 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• Unilateral stroke including basal ganglia lesion patients

• Chronic patients over 6 months after onset

• 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.

Behavioral:
• Motor learning
Sequential finger tapping task training is applied to stroke patients.

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
Other	Resting-state functional MRI	Before intervention, MRI is acquired to extract brain characteristics of stroke patients.	Baseline (Before stimulation sessions)
Other	Changes in cortical activity using fNIRS signals.	Before intervention, fNIRS image is acquired to extract cortical activation of stroke patients.	Baseline (Before stimulation sessions)
Primary	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, immediately after five brain stimulation sessions
Secondary	Changes in cortical activity using fNIRS signals during brain stimulation	Cortical activities before, during and after brain stimulation sessions are compared.	Baseline, during, immediately after five 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, immediately after five brain stimulation sessions
Secondary	9-hole pegboard test	The test is a standardized, quantitative assessment used to measure finger dexterity of a patient.	Baseline, 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, 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, immediately after five brain stimulation sessions
Secondary	Sequential Finger tapping test	Response time is measured during sequential finger tapping task.	Baseline, 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, immediately after five brain stimulation sessions