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The Effect of Low-Level Light Therapy on the Electrical Activity of the Brain in Stroke Patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Experimental Group (850nm PBM + Standard Rehabilitation) | Experimental |
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| Arm 2: Control Group ( Standard Rehabilitation) | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| photobiomodulation (PBM) | Device | Experimental Group: Participants will receive iSyncWave transcranial photobiomodulation (tPBM) and speech therapy, with 20 minutes per modality per session, once daily, 5 days per week, for 4 weeks, totaling 20 sessions of combined intervention. During the intervention period, changes in concomitant medications and concurrent therapies will be monitored and recorded; any modifications to medications or therapies must be documented in detail. |
| Measure | Description | Time Frame |
|---|---|---|
| electroencephalography (EEG) | Change in from baseline to post 20 sessions (up to approximately 4 weeks) α-Wave Increased amplitude, β-Wave moderate amplitude enhancement and θ-Wave Decreased excessive amplitude indicate functional recovery. |
| Measure | Description | Time Frame |
|---|---|---|
| Korean-Western Aphasia Battery(K-WAB) | Change in Korean-Western Aphasia Battery from baseline to post 20 sessions (up to approximately 4 weeks), Higher scores indicate better language function(Total score range: 0-100 points). | |
| Boston Naming Test (BNT) |
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Inclusion Criteria:
Adult patients (≥ 18 years old) ，less than 80 years old，who have signed the informed consent form, or patients with proxy consent.
Exclusion Criteria:
Patients judged to have an unstable surgical site following hemorrhagic stroke-related surgery.
Pregnant or lactating individuals. Individuals with a history of seizures. Individuals who have participated in clinical studies twice or more in the same year or in other clinical studies within 6 months.
Other individuals with clinically significant findings deemed medically inappropriate for the study by the principal investigator or responsible researcher.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Il Yong Shin | Contact | 010-6535-0310 | rmshin01@gmail.com |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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| control group-receive speech therapy | Other | Participants will receive speech therapy at a frequency of 20 minutes per session, once daily, 5 days per week, for 4 weeks, with a total of 20 sessions. |
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| Change in Boston Naming Test from baseline to post 20 sessions (up to approximately 4 weeks), Higher scores indicate better naming ability(Total score range: 0-60 points). |
| K-MMSE (Korean-Mini-Mental State Examination) | Change in K-MMSE (Korean-Mini-Mental State Examination) from baseline to post 20 sessions (up to approximately 4 weeks), Higher scores indicate better global cognitive function(Total score range: 0-30 points). |
| K-MoCA (Korean-Montreal Cognitive Assessment) | Change in K-MoCA (Korean-Montreal Cognitive Assessment) from baseline to post 20 sessions (up to approximately 4 weeks), Higher scores indicate better cognitive function(Total score range: 0-30 points). |
| CDR ( Clinical Dementia Rating Scale) | Change in CDR ( Clinical Dementia Rating Scale) from baseline to post 20 sessions (up to approximately 4 weeks), Lower scores indicate better cognitive function(Total score range: 0-18 points). |
| Beck Depression Inventory | Change in Beck Depression Inventory from baseline to post 20 sessions (up to approximately 4 weeks), Lower scores indicate milder depression (The total score range is 0-63 points). |
| EuroQol 5-Dimension Questionnaire(EQ-5D) | Change in EuroQol 5-Dimension Questionnaire(EQ-5D) from baseline to post 20 sessions (up to approximately 4 weeks), Higher scores indicate better quality of life(Total score range: -0.171 ~ 1.000 points). |