Transcranial Direct Current Stimulation (tDCS) in the Primary Motor Cortex in Healthy Individuals

NCT04148547 | Completed

• 1 other identifier: uammadrid4
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of this study is to assess the short-term effects of active-tDCS (a-tDCS) on the M1 regarding sensorimotor variables such as discriminative sensation, pressure pain threshold and electromyographic activity compared with a sham-tDCS (s-tDCS) in healthy individuals. The main objective was to determine whether there were clinically relevant changes generated by tDCS and if they were superior to a sham intervention.

Conditions

Basic Physiology; Brain Stimulation

Keywords

Transcranial direct current stimulation

Outcome Measures

Primary Outcomes (3)

• Pressure pain threshold through an algometer

  Pressure pain threshold has been defined as the minimal amount of pressure at which a sense of pressure first changes to pain or discomfort

  Change in pressure pain threshold immediately at the end of the intervention

• Tactile acuity threshold

  Tactile acuity threshold is an important variable to know the somatosensory state and Von Frey monofilaments and Aesthesiometer were used

  Change in tactile acuity threshold immediately at the end of the intervention

• Muscle recruitment through electromyographic activity

  The activity of surface electromyography (sEMG) during an isometric maximal voluntary contraction was measured in the biceps brachii and rectus femoris.

  Change in electromyographic activity immediately at the end of the intervention

Study Arms (2)

transcranial direct current stimulation

EXPERIMENTAL

Device: Sooma transcranial direct current stimulation device

Sham transcranial direct current stimulation

PLACEBO COMPARATOR

Device: Placebo Sooma transcranial direct current stimulation device

Interventions

Sooma transcranial direct current stimulation device DEVICE

This group received brain training through transcranial direct current for 20 minutes.

transcranial direct current stimulation

Placebo Sooma transcranial direct current stimulation device DEVICE

This group received sham brain training through transcranial direct current for 20 minutes. The current is active for 15 seconds and then switches off until the intervention is finished.

Sham transcranial direct current stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• asymptomatic participants
• men and women aged 18 to 65 years

You may not qualify if:

• insomnia
• nausea
• headache
• pregnancy
• use of painkillers in the last 24 hours
• presence of metal inside the head
• pacemaker
• wound on the area of electrodes' application
• drug consumption; (j) recent application of tDCS
• psychiatric disease impeding understanding of the study.

Sponsors & Collaborators

• Universidad Autonoma de Madrid: lead
• Centro Universitario La Salle: collaborator

Study Sites (1)

CSEU La Salle

Madrid, 28023, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 1, 2019
• Study Start: September 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 30, 2019
• Last Updated: November 5, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)