Improvement Effect of Transcranial Direct Current Stimulation (tDCS) Applied During Exercise Training in Stroke Patients With Upper Limb and Hand Motor Function

Stroke Clinical Trial

Official title:

Improvement Effect of Transcranial Direct Current Stimulation (tDCS) Applied During Exercise Training in Stroke Patients With Upper Limb and Hand Motor Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05275114
• Other study ID #: 2021-06-176
• Status: Completed
• Phase: N/A
• Start date: March 11, 2022
• Est. completion date: August 31, 2022

Study information

• Verified date: September 2022
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to improve the effect of Transcranial Direct Current Stimulation (tDCS) applied during exercise training in stroke patients with upper limb and hand motor function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients aged 19 to 80 years

• Less than 58 FMA Upper scores

• Patients whose lesions do not include stimulation regions

• Patients with stroke with more than 3 months of onset

Exclusion Criteria:

• Difficult to communicate due to severe language impairment.

• Accompanied by an existing serious neurogenic disease

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

• If there are difficulties in conducting the research

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

• Patients with contraindicated MRI scans

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• tDCS stimulation with hand task
30 minutes of intervention including tDCS stimulation with hand task and fNIRS measurements for 10 days in 4 weeks
• sham tDCS stimulation with hand task
30 minutes of intervention including sham tDCS stimulation with hand task and fNIRS measurements for 10 days in 4 weeks

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Yun-Hee Kim	Cybermedic Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Fugl-Meyer Assessment	The score is a stroke-specific, performance-based impairment index. The degree of impairment of upper and lower limbs is measured.	Session 0 (initial visit);; Session 10 (at approximatel 4 weeks)
Secondary	Change in 9-hole pegboard test	The test is a standardized, quantitative assessment used to measure finger dexterity of a patient.	Baseline(initial visit); Session 10 (at approximatel 4 weeks)
Secondary	Change in Grip & Tip pinch strength	The test is to measure the maximum isometric strength of hand, forearm, and finger muscles.	Baseline(initial visit); Session 10 (at approximatel 4 weeks)
Secondary	Change in Sequential finger tapping reaction time and accruacy	Response time and accuracy are measured during finger tapping task.	Baseline(initial visit); Session 10 (at approximatel 4 weeks)
Secondary	Change in 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(initial visit); Session 10 (at approximatel 4 weeks)
Secondary	Change in Box and 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(initial visit); Session 10 (at approximatel 4 weeks)
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.	[Time Frame: session 0 (initial visit); session 10 (at approximately 4 weeks)]
Secondary	Changes in Brain activation of resting-state functional MRI	Measure of Neuroplasticity	[Time Frame: session 0 (initial visit); session 10 (at approximately 4 weeks)]