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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: tDCS stimulation with hand task; Device: sham tDCS stimulation with hand task

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hand Tasks + M1(1mA) & aIPS(1mA) tDCS; 20 minutes of Hand Taks + applying 30 minutes of M1(1mA) & aIPS(1mA) tDCS and fNIRS	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
Active Comparator: Hand Tasks + Sham tDCS; 20 minutes of Hand Tasks + 30 minutes of sham tDCS and fNIRS	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)]
Changes in Brain activation of resting-state functional MRI	Measure of Neuroplasticity	[Time Frame: session 0 (initial visit); session 10 (at approximately 4 weeks)]

Collaborators and Investigators

• Sponsor: Yun-Hee Kim
• Collaborators: Cybermedic Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2022
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: March 1, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 20, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2021-06-176

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No