Effect of Different Currents for Transcranial Modulation of the Sensorimotor Corticospinal Pathway in Healthy Subjects: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Resting-State EEG Power Spectra Across Frequency Bands (Delta, Theta, Alpha, Beta 1, Beta 2, and Gamma)
研究概览
简要总结
Transcranial modulation of the corticospinal sensorimotor pathway is a promising approach in neuroscientic functions. Among the techniques used, transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS) and the application of random noise current stand out. Objective: To compare the e stimulus, in the EEG frequency bands, on Motor Evoked Potentials (MEP) and on the functional activation of the motor cortex, assessed by Functional Near Infrared Spectroscopy (fNIRS) and pain measurements in healthy subjects subjected to a standardized algogenic stimulus. Subjects and Method: This is a randomized, double-blind, controlled and crossover clinical trial, involving the inclusion of 14 healthy male subjects, with complete secondary education, aged between 18 and 40. years. Participants will be randomized to receive Transcranial Direct Current Stimulation (tDCS), (2) Transcranial Alternating Current Stimulation (tACs), (3) Random Noise Current, (4) Simulated Stimulation Session and (5) Rest Session. Experimental conditions will take place in a standard, quiet and bright room. Assessments will include Motor Evoked Potential, Heat Pain Threshold, Motor Area Activation through metabolic activation measured by fNIRS and analysis of EEG frequency waves. After the baseline assessment, participants will undergo a session of transcranial stimulation, followed by an algogenic stimulus with water at zero degrees, immersion of the dominant hand for 1 minute, with rest intervals of 3 minutes between each of the four serial stimuli. After this stimulus session, outcome measurements will be carried out. Expected results: This clinical trial is expected to provide insights into how tDCS, tACs and random stimulation in to an algogenic stimulus. The results may contribute to the development of therapeutic or neuromodulation strategies in clinical conditions where the regulation of the cortico-spinal sensorimotor pathway is relevant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects aged 18-45 years, with at least a high school diploma, and not engaged in night-shift work.
排除标准
- •Contraindications to transcranial stimulation include implanted medical devices in the brain, cardiac pacemakers, and cochlear implants.
- •Current use of psychotropic medications.
- •History of alcohol or substance abuse within the past 6 months.
- •Neurological disorders, history of traumatic brain injury, or prior neurosurgery.
- •Beck Depression Inventory-II (BDI-II) score >
- •Self-Reporting Questionnaire (SRQ) score >7.
研究组 & 干预措施
Transcranial Direct Current Stimulation (tDCS) over motor area (M1)
Participants receive active transcranial direct current stimulation over the primary motor cortex (M1) during the intervention sessions.
干预措施: Transcranial Direct Current Stimulation (Device)
Transcranial Alternating Current Stimulation (tACS) over M1
Participants receive active transcranial alternating current stimulation over the primary motor cortex (M1) during the intervention sessions.
干预措施: Transcranial Alternating Current Stimulation (Device)
Transcranial Random Noise Stimulation (tRNS) over M1
Participants receive active transcranial random noise stimulation over the primary motor cortex (M1) during the intervention sessions.
干预措施: Transcranial Random Noise Stimulation (tRNS) (Device)
Sham Stimulation
Participants undergo sham stimulation, experiencing the same setup as active stimulation without actual current delivery.
干预措施: Sham Stimulation (Device)
Rest State
Participants remain seated with their eyes open for 20 minutes during the rest session, without performing any other task.
结局指标
主要结局
Resting-State EEG Power Spectra Across Frequency Bands (Delta, Theta, Alpha, Beta 1, Beta 2, and Gamma)
时间窗: Immediately before and immediately after the intervention.
Electroencephalography (EEG) will be used to quantify neuronal activity through quantitative EEG (qEEG) analysis. Resting-state EEG power spectra will be analyzed across delta, theta, alpha, beta, and gamma frequency bands, reflecting synchronized neuronal oscillations. EEG data will be recorded using a 20-electrode montage according to the international 10-20 system during an 8-minute resting-state paradigm with alternating eyes-open and eyes-closed conditions. Cortical source localization will be performed using standardized Low-Resolution Brain Electromagnetic Tomography (sLORETA).
次要结局
- Corticospinal Excitability(Immediately before and immediately after the intervention.)
- Motor Cortex Functional Connectivity(Immediately before and immediately after the intervention.)
- Heat Pain Threshold(Immediately before and immediately after the intervention.)
- Function of the Descending Pain Inhibitory System(Immediately before and immediately after the intervention.)
- Cold Pressor Test Pain Tolerance(Immediately before and immediately after the intervention.)
