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

P

Pusan National University Yangsan Hospital

Status

Not yet enrolling

Conditions

Post-stroke Aphasia

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07323823
21-2025-009

Details and patient eligibility

About

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

Enrollment

66 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

66 participants in 2 patient groups

Arm 1: Experimental Group (850nm PBM + Standard Rehabilitation)
Experimental group
Treatment:
Other: control group-receive speech therapy
Device: photobiomodulation (PBM)
Arm 2: Control Group ( Standard Rehabilitation)
Sham Comparator group
Treatment:
Other: control group-receive speech therapy

Trial contacts and locations

0

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Central trial contact

Il Yong Shin

Data sourced from clinicaltrials.gov

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