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ENROLLING BY INVITATION
NCT07831525
NA

Effect of Different Currents for Transcranial Modulation of the Sensorimotor Corticospinal Pathway in Healthy Subjects

Sponsor: Hospital de Clinicas de Porto Alegre

View on ClinicalTrials.gov

Summary

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.

Official title: Effect of Different Currents for Transcranial Modulation of the Sensorimotor Corticospinal Pathway in Healthy Subjects: A Randomized Clinical Trial

Key Details

Gender

MALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

14

Start Date

2026-07-15

Completion Date

2026-12-26

Last Updated

2026-09-21

Healthy Volunteers

Yes

Interventions

DEVICE

Transcranial Alternating Current Stimulation

Single session of active gamma transcranial alternating current stimulation delivered for 30 minutes using a battery-powered external stimulator. Stimulation is applied through two sponge electrodes (5 × 7 cm) mounted on a neoprene cap. The stimulation frequency is 40 Hz, based on previous gamma-band transcranial alternating current stimulation (tACS) studies. The anode is positioned at C3 (left primary motor cortex, M1), and the cathode over the ipsilateral clavicular region.

DEVICE

Transcranial Direct Current Stimulation

Stimulation is delivered using two sponge electrodes (5 × 7 cm) mounted on a neoprene cap. The electrodes are positioned on the scalp according to the international 10-20 system. The anode is placed at position C3 (left primary motor cortex, M1) and the cathode over the ipsilateral clavicular region. The sinusoidal current intensity per channel ranges from ±2 mA. The session duration is 20 minutes.

DEVICE

Transcranial Random Noise Stimulation (tRNS)

Stimulation is delivered using two sponge electrodes mounted on a neoprene cap. The anode is positioned at C3 (left primary motor cortex, M1), and the cathode over the ipsilateral clavicular region. A random current level is generated for each sample at a sampling rate of 1280 samples per second. The random values are normally distributed, following a bell-shaped probability density function. The noise signal contains all frequencies up to half the sampling rate (maximum 640 Hz) and has no DC offset.

DEVICE

Sham Stimulation

During the sham stimulation session, the tDCS device ramps up the current to 2 mA over 30 seconds and then is immediately turned off. This procedure mimics the sensations of active stimulation without delivering therapeutic current for the remainder of the session.

Locations (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil