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

NCT ID: NCT07323823

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-12-31

Brief Summary

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

Conditions

Post-stroke Aphasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

photobiomodulation (PBM)

Intervention Type: 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.

control group-receive speech therapy

Intervention Type: 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 2: Control Group ( Standard Rehabilitation)

Group Type: SHAM_COMPARATOR

control group-receive speech therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pusan National University Yangsan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yong-il Shin

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Il Yong Shin

Role: CONTACT

rmshin01@gmail.com

010-6535-0310

Other Identifiers

21-2025-009

Identifier Type: -

Identifier Source: org_study_id