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

NCT07323823 | Not Yet Recruiting

• 1 other identifier: 21-2025-009
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Post-stroke Aphasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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).

Study Arms (2)

Arm 1: Experimental Group (850nm PBM + Standard Rehabilitation)

EXPERIMENTAL

Device: photobiomodulation (PBM); Other: control group-receive speech therapy

Arm 2: Control Group ( Standard Rehabilitation)

SHAM COMPARATOR

Other: control group-receive speech therapy

Interventions

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.

Arm 1: Experimental Group (850nm PBM + Standard Rehabilitation); Arm 2: Control Group ( Standard Rehabilitation)

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.

Arm 1: Experimental Group (850nm PBM + Standard Rehabilitation)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Il Yong Shin

CONTACT

010-6535-0310; rmshin01@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 7, 2026
• Study Start: December 31, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share