Stroke
Conditions
Brief 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.
Interventions
DEVICEtDCS stimulation with hand task
30 minutes of intervention including tDCS stimulation with hand task and fNIRS measurements for 10 days in 4 weeks
DEVICEsham 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
Sponsors
Cybermedic Co., Ltd.
Yun-Hee Kim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fugl-Meyer Assessment | Session 0 (initial visit);; Session 10 (at approximatel 4 weeks) | The score is a stroke-specific, performance-based impairment index. The degree of impairment of upper and lower limbs is measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 9-hole pegboard test | Baseline(initial visit); Session 10 (at approximatel 4 weeks) | The test is a standardized, quantitative assessment used to measure finger dexterity of a patient. |
| Change in Grip & Tip pinch strength | Baseline(initial visit); Session 10 (at approximatel 4 weeks) | The test is to measure the maximum isometric strength of hand, forearm, and finger muscles. |
| Change in Sequential finger tapping reaction time and accruacy | Baseline(initial visit); Session 10 (at approximatel 4 weeks) | Response time and accuracy are measured during finger tapping task. |
| Changes in Brain activation of resting-state functional MRI | [Time Frame: session 0 (initial visit); session 10 (at approximately 4 weeks)] | Measure of Neuroplasticity |
| Change in Box and Block test | Baseline(initial visit); Session 10 (at approximatel 4 weeks) | The test is used to measure the gross manual dexterity of a patient, or of a person using an upper limb prosthetic device. |
| Changes in motor evoked potential | [Time Frame: session 0 (initial visit); session 10 (at approximately 4 weeks)] | 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. |
| Change in Jebsen-Taylor hand function test | Baseline(initial visit); Session 10 (at approximatel 4 weeks) | This test is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL). |
Countries
South Korea
Outcome results
None listed