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

Официальное название

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

Обзор

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

Вмешательства

• Устройство 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.
• Другое 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.

Первичные конечные точки

• electroencephalography (EEG) [Срок оценки: 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.]

Вторичные конечные точки (7)

• Korean-Western Aphasia Battery(K-WAB) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07323823 · 21-2025-009

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗