The Effect of PBM on the Electrical Activity of the Brain in Stroke Patients (PBM)

The Effect of 850 nm Photobiomodulation Therapy (PBM) on the Electrical Activity of the Brain in Stroke Patients

The Effect of Low-Level Light Therapy on the Electrical Activity of the Brain in Stroke Patients

Study Overview

• Status: Not yet recruiting
• Conditions: Post-stroke Aphasia
• Intervention / Treatment: Device: photobiomodulation (PBM); Other: control group-receive speech therapy

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Il Yong Shin; Phone Number: 010-6535-0310; Email: rmshin01@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Experimental Group (850nm PBM + Standard Rehabilitation)	Device: photobiomodulation (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.; Other: control 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.
Sham Comparator: Arm 2: Control Group ( Standard Rehabilitation)	Other: control 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.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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)	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).

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 31, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 22, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Laser Therapy; Phototherapy; Low-Level Light Therapy
• Other Study ID Numbers: 21-2025-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

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