The Effect of tDCS Based on Functional Brain Imaging for Subacute Stroke Patients

Stroke Clinical Trial

Official title:

The Effect of tDCS Based on Functional Brain Imaging for Subacute Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05142917
• Other study ID #: 2021-10-092-001
• Status: Completed
• Phase: N/A
• Start date: February 11, 2022
• Est. completion date: January 8, 2023

Study information

• Verified date: November 2021
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether brain imaging-based hand function area tDCS stimulation is more effective than conventional stimulation or sham stimulation for improving hand motor function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 8, 2023
• Est. primary completion date: January 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• Unilateral stroke patients aged 19 to 80 years

• Patients with subacute stroke within 4 weeks of onset

• Patients with moderate or severe upper extremity dysfunction with an upper extremity FMA score of less than 58 in motor function evaluation

Exclusion Criteria:

• Accompanied by an existing serious neurogenic disease

• Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder, and dementia.

• If there are difficulties in conducting the research

• Any patients who are judged by the investigator to be difficult to participate in this study

• Exclusion criteria for transcranial direct current stimulation:

i) Patients with implanted medical devices in the body (e.g. pacemakers) ii) When a metal object is inserted in the skull iii) If there is a wound on the skin of the attachment site iv) history of epilepsy v) Pregnant and lactating women

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:
• Hand motor task
Various type of hand motor tasks are 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	Changes of score: 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, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session
Secondary	Changes of score: 9-hole pegboard test	The test is a standardized, quantitative assessment used to measure finger dexterity of a patient.	Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session
Secondary	Changes of score: Grip & Tip pinch strength test	The test is to measure the maximum isometric strength of hand, forearm, and finger muscles.	Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session
Secondary	Changes in 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, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session
Secondary	Changes of score: 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, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session
Secondary	Changes of score: Korean-Montreal Cognitive Assessment	This test is a cognitive function test tool consisting of spatiotemporal/executive function, naming, memory, attention, language function, abstraction, and orientation.	Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session
Secondary	Changes of score: Korean version of Modified Barthel Index	Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients or patients with other disabling conditions.	Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session
Secondary	Changes of score: Geriatric Depression Scale-Short Form	The test is a self-report measure of depression in older adults.	Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session
Secondary	Changes in cortical activity using fNIRS signals	Cortical activities before, during and after brain stimulation sessions are compared.	Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session