Frequency-Dependent Effects of Transcranial Photobiomodulation With Same Peak Irradiance on Cortical Excitability and Fine Motor Performance
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial Photobiomodulation.
- Who it may be relevant to
- Registry conditions: Healthy Volunteers (HV), Transcranial Photobiomodulation, Cortical Excitability. Basic parameters: 18 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Frequency-Dependent Effects of Transcranial Photobiomodulation With Same Peak Irradiance on Cortical Excitability and Fine Motor Performance: A Randomized, Double-Blind, Sham-Controlled, Within-Subject Crossover Trial
Overview
This study investigates the frequency-dependent neuromodulatory effects of transcranial photobiomodulation (tPBM) over the primary motor cortex (M1) on cortical excitability and fine motor performance in healthy young adults. Using a randomized, double-blind, sham-controlled, 5-arm crossover design, 20 healthy participants will undergo five experimental conditions separated by a mandatory 7-day washout period: Continuous Wave (CW), 10 Hz pulsed tPBM, 40 Hz pulsed tPBM, 100 Hz pulsed tPBM, and a Sham control. To isolate pulse frequency while holding peak intensity constant, all active interventions will utilize an identical peak irradiance, with pulsed modes operating at a 50% duty cycle (delivering 50% of the cumulative energy dose relative to CW). Primary outcomes include corticospinal excitability measured via single- and paired-pulse Transcranial Magnetic Stimulation (TMS), alongside fine motor speed and dexterity assessed via a computerized finger-tapping task.
Detailed description
Transcranial photobiomodulation (tPBM) has emerged as a promising non-invasive tool to modulate neural activity through the absorption of near-infrared (NIR) photons by mitochondrial cytochrome c oxidase (CCO). However, whether the biological effects on the human cortex are driven solely by cumulative energy delivery or are significantly modulated by pulse frequency remains a critical question in neurophysiology. This study implements a rigorous within-subject crossover design to systematically isolate the effects of pulse frequency from total dosimetric parameters. Participants and Screening: A sample of 20 healthy volunteers (aged 18-35) will be recruited. Potential candidates will undergo a strict screening protocol to ensure safety and baseline homogeneity. Exclusion criteria include any contraindications to magnetic fields assessed by the Transcranial Magnetic Stimulation Adult Safety Screen (TASS; Rossi et al., 2021), psychiatric conditions according to DSM-5, a history of neurological disorders, the use of psychotropic medications within the last 12 months, or prior participation in an interventional neuromodulation study within the preceding 6 months. Experimental Design \& Intervention: Enrolled participants will complete five experimental sessions in a randomized, counterbalanced order to eliminate carryover or sequence effects, separated by a mandatory washout period to ensure the return of cortical excitability to baseline. In each session, a clinical-grade near-infrared system will be applied over the primary motor cortex (M1) hot spot. The five experimental arms consist of: Continuous Wave (CW) tPBM - NIR light delivered continuously at baseline peak irradiance, 1x total cumulative energy dose; 10 Hz Pulsed tPBM - NIR light pulsed at 10 Hz with identical peak irradiance as CW and a 50% duty cycle, 0.5x total dose relative to CW; 40 Hz Pulsed tPBM - NIR light pulsed at 40 Hz with identical peak irradiance as CW and a 50% duty cycle, 0.5x total dose relative to CW; 100 Hz Pulsed tPBM - NIR light pulsed at 100 Hz with identical peak irradiance as CW and a 50% duty cycle, 0.5x total dose relative to CW; sham Control - a dedicated low-intensity red light photobiomodulation device emitting visible red light at sub-therapeutic levels to maintain participant blinding. Double-blinding will be enforced for the participant and investigator. Alphanumeric codes will mask the active protocols on the user interface, and participants will wear opaque safety goggles. Outcome Measures: Multiple neurophysiological, behavioral, and safety endpoints will be collected immediately pre-intervention (baseline) and post-intervention. Neurophysiology (TMS): Motor Evoked Potential (MEP) amplitude (primary excitability index); Intracortical Facilitation (ICF); Short-Interval Intracortical Inhibition (SICI); and Cortical Silent Period (CSP). Behavioral Performance (FTT): Evaluated via a dedicated Android application tracking total number of taps, variability of the inter-tap interval (vITI), spatial resultant sum (Σ\|\|Δr\|\|), and the 95% confidence ellipse area (X,Y).Safety and Hemodynamics: Systemic tolerability will be recorded via the Systematic Assessment for Treatment Emergent Events - Systematic Inquiry (SAFTEE-SI). Hemodynamic variations will be closely monitored through independent analyses of Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Heart Rate (HR). Data will be processed using Linear Mixed-Effects Models to account for the repeated-measures structure of the crossover design.
Interventions
- Combination product Transcranial Photobiomodulation
Transcranial photobiomodulation (tPBM) is a non-invasive, non-thermal neuromodulatory modality that utilizes low-power coherent (laser) or non-coherent (light-emitting diodes, LEDs) light sources within the red (lambda = 600-700 nm) and near-infrared (NIR; lambda = 700-1100 nm) spectral windows to modulate cortical function. Structurally tailored to penetrate superficial anatomical barriers-including the scalp, skull, and meninges-tPBM delivers photons directly to the cerebral cortex.
Primary outcome measures
- Motor Evoked Potential (MEP) Amplitude - TMS [Time frame: Immediately before the intervention (pre-intervention) and 20 minutes after the intervention (post-intervention)]
- Intracortical Facilitation (ICF) - TMS [Time frame: Immediately before the intervention (pre-intervention) and 20 minutes after the intervention (post-intervention)]
- Short-Interval Intracortical Inhibition (SICI) - TMS [Time frame: Immediately before the intervention (pre-intervention) and 20 minutes after the intervention (post-intervention)]
- Cortical Silent Period (CSP) - TMS [Time frame: Immediately before the intervention (pre-intervention) and 20 minutes after the intervention (post-intervention)]
Secondary outcome measures (5)
- Total Number of Taps - FTT [Time frame: Immediately before the intervention (pre-intervention) and immediately after the intervention (post-intervention)]
- Variability of the Inter-Tap Interval (vITI) - FTT [Time frame: Immediately before the intervention (pre-intervention) and immediately after the intervention (post-intervention)]
- Spatial Resultant Sum (Σ||Δr||) - FTT [Time frame: Immediately before the intervention (pre-intervention) and immediately after the intervention (post-intervention)]
- 95% Confidence Ellipse Area (X,Y) - FTT [Time frame: Immediately before the intervention (pre-intervention) and immediately after the intervention (post-intervention)]
- Adverse Events and Tolerability (SAFTEE-SI) [Time frame: Baseline, before all interventions and one week after the last intervention]
Eligibility criteria
Inclusion criteria
- Voluntary Participation: Participants who are clear of their cognitive faculties, capable of understanding all experimental procedures, and who provide written informed consent prior to enrollment.
- Neurologically and Psychiatrically Healthy Status: Individuals with no current or prior history of neurological, neurodevelopmental, or psychiatric conditions;
- Age Range: Young adult volunteers aged between 18 and 35 years.
Exclusion criteria
- Use of any continuous psychotropic medication within the past 12 months.
- Any current psychiatric diagnosis based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- Diagnosis of any neurological disorder capable of altering cortical excitability (e.g., seizures/epilepsy, cerebrovascular accidents/stroke, brain tumors).
- Any clinical, psychological, or social condition that, in the investigator's opinion, places the participant at an increased risk, compromises participant safety, or precludes full compliance and successful completion of the study protocol.
- Presence of any intracranial devices or implants, including cochlear implants and aneurysm clips.
- Severe or uncompensated systemic medical illness that could interfere with study participation or confound physiological outcomes.
- Participation in any other interventional neuromodulation study within the preceding 6 months.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Hospital de Clínicas de Porto Alegre — Porto Alegre
Identifiers
NCT: NCT07752602 · 2025-0082 B