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

N/ANot Yet RecruitingNCT07323823

Pusan National University Yangsan Hospital66 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Post-stroke Aphasia

Interventions

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.

control group-receive speech therapyOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: 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).

Central Contacts

Il Yong Shin

CONTACT

010-6535-0310 rmshin01@gmail.com

Data from ClinicalTrials.gov

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