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

ConditionPost-stroke Aphasia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPusan National University Yangsan Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Individuals with photosensitive skin at risk of developing urticaria or dermatitis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Arm 1: Experimental Group (850nm PBM + Standard Rehabilitation)Experimental treatment 2 interventions
Group B: Arm 2: Control Group ( Standard Rehabilitation)Sham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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).
2

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).
3

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).
4

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).

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pusan National University Yangsan Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: