---
title: The Effect of PBM on the Electrical Activity of the Brain in Stroke Patients
nct_id: NCT07323823
overall_status: NOT_YET_RECRUITING
phase: NA
sponsor: Pusan National University Yangsan Hospital
study_type: INTERVENTIONAL
primary_condition: Post-stroke Aphasia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07323823.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07323823"
ct_last_update_post_date: 2026-01-07
last_seen_at: "2026-05-12T06:12:04.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The Effect of PBM on the Electrical Activity of the Brain in Stroke Patients

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

**NCT ID:** [NCT07323823](https://clinicaltrials.gov/study/NCT07323823)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 66
- **Lead Sponsor:** Pusan National University Yangsan Hospital
- **Conditions:** Post-stroke Aphasia
- **Start Date:** 2025-12-31
- **Completion Date:** 2026-12-31
- **CT.gov Last Update:** 2026-01-07

## Brief Summary

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

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Arm 1: Experimental Group (850nm PBM + Standard Rehabilitation)** (EXPERIMENTAL)
- **Arm 2: Control Group ( Standard Rehabilitation)** (SHAM_COMPARATOR)

## 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 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.

## 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).)_
- **EuroQol 5-Dimension Questionnaire(EQ-5D)** _(time frame: 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).)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07323823.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07323823*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*