Post-stroke Aphasia
Conditions
Brief summary
The Effect of Low-Level Light Therapy on the Electrical Activity of the Brain in Stroke Patients
Interventions
DEVICEphotobiomodulation (PBM)
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.
OTHERcontrol group-receive speech therapy
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.
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with ischemic or hemorrhagic stroke by a specialist. Patients in the recovery phase within 1 year after onset; those with confirmed clinical functional impairment upon assessment, who are conscious and able to cooperate with PBM stimulation and evaluations. Adult patients (≥ 18 years old) ，less than 80 years old，who have signed the informed consent form, or patients with proxy consent.
Exclusion criteria
* Individuals with photosensitive skin at risk of developing urticaria or dermatitis. 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.
Design outcomes
Primary
| Measure | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Boston Naming Test (BNT) | 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). |
| 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). |
| 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). |
| 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). |
Contacts
Primary ContactIl Yong Shin
Outcome results
None listed