NCT07323823Not yet recruitingNot Applicable
The Effect of 850 nm Photobiomodulation Therapy (PBM) on the Electrical Activity of the Brain in Stroke Patients
Pusan National University Yangsan Hospital0 sites66 target enrollmentStarted: December 31, 2025Last updated:
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 66
- Primary Endpoint
- electroencephalography (EEG)
Study Overview
Brief Summary
The Effect of Low-Level Light Therapy on the Electrical Activity of the Brain in Stroke Patients
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Arm 1: Experimental Group (850nm PBM + Standard Rehabilitation)
Experimental
Intervention: photobiomodulation (PBM) (Device)
Arm 1: Experimental Group (850nm PBM + Standard Rehabilitation)
Experimental
Intervention: control group-receive speech therapy (Other)
Arm 2: Control Group ( Standard Rehabilitation)
Sham Comparator
Intervention: control group-receive speech therapy (Other)
Outcomes
Primary Outcomes
electroencephalography (EEG)
Time Frame: 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 Outcomes
- 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)(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).)
Investigators
Yong-il Shin
PhD
Pusan National University Yangsan Hospital
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