NCT03157869

Brief Summary

Motor learning occurs with structural and functional modifications in neural networks that meet a certain demand. The improvement of performance in diverse activities is a measure of learning, as well as the generalization and transference of this capacity. Transcranial direct current stimulation (tDCS) is a modulation technique of brain activity that modifies cortical excitability, causing changes in motor evoked potentials that influence motor learning. Modifications similar to the long-term potentiation, essential for learning processes, have also been described after applying tDCS. The primary motor cortex is the area of stimulation where there is more robust evidence in favor of increased motor learning. PURPOSE: to investigate the effects of anodic tDCS on the learning of sequential finger movements in young and healthy individuals.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2017

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 1, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2018

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

May 1, 2017

Last Update Submit

October 10, 2018

Conditions

Keywords

Learning, Automatism, Motor Activity, Electric Stimulation

Outcome Measures

Primary Outcomes (2)

  • Speed

    The speed (number of repetitions in a minute) of sequential movements will be used as a measure of performance. These measures will be performed prior to training, immediately after, 48 hours, 7 days, and 28 days after trained hand training (TH) for assessment of short and long term learning. In addition, performance evaluations (1) of the reverse-trained sequence in TH will be performed to evaluate the generalization; (2) of the trained sequence in left hand (non-trained) to evaluate the intermanual transfer; and (3) trained sequence in TH in double-task condition to evaluate automaticity.

    Up to 28 days

  • Accuracy

    The accuracy (number of errors in a minute) in the same way as described to Outcome 1

    Up to 28 days

Study Arms (2)

Transcranial Direct Current Stimulation

EXPERIMENTAL

* Intervention: anodic tDCS (20 minutes ON, intensity 2milliamps) on the primary motor cortex contralateral of the trained hand (right) simultaneously to the motor training and supraorbital cathode ipsilateral * Motor training will consist of 8 blocks with 300 repetitions of sequential finger movements performed with the right hand.

Device: Transcranial Direct Current Stimulation

Control

SHAM COMPARATOR

* Intervention: simulated anodic tDCS (30 seconds ON, intensity 2milliamps) on the primary motor cortex contralateral of the trained hand (right) simultaneously to the motor training and supraorbital cathode ipsilateral * Motor training will consist of 8 blocks with 300 repetitions of sequential finger movements performed with the right hand.

Other: Simulated

Interventions

Anodic tDCS during 20 minutes ON, intensity 2milliamps, on the contralateral motor cortex of the trained hand simultaneously with the motor training. The cathode (negative electrode) will be positioned over the contralateral supraorbital region. It wil be used rubber electrodes covered by a vegetal electrode embedded in saline solution, physiological saline, measuring 5 x 5 cm (25 cm2).

Transcranial Direct Current Stimulation

Simulated anodic tDCS (only 30 seconds ON), intensity 2milliamps, on the contralateral motor cortex of the trained hand simultaneously with the motor training. The cathode (negative electrode) will be positioned over the contralateral supraorbital region. It wil be used rubber electrodes covered by a vegetal electrode embedded in saline solution, physiological saline, measuring 5 x 5 cm (25 cm2).

Control

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Young subjects aged between 18 and 35 years, right-hand (evaluated by the Edinburgh Inventory), of both genders, attending the third grade in a private university.

You may not qualify if:

  • Individuals using central nervous system drugs with uncorrected visual and / or auditory disorders who have any neurological, psychiatric, or orthopedic diseases and who have differentiated finger, musician or typist skills will be excluded.
  • Due to the electrostimulation procedure, individuals who use hair chemistry, individuals who have a metallic implant on the head or a pacemaker, and who have scars in the region to be stimulated will also be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of Research of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University

São Paulo, São Paulo, 05360-000, Brazil

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Transcranial Direct Current StimulationSimulate composite resin

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Maria Elisa P Piemonte, PhD

    University of Sao Paulo

    STUDY DIRECTOR

Central Study Contacts

Maria Elisa P Piemonte, PhD

CONTACT

Andrea P Zomignani, PhD student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 1, 2017

First Posted

May 17, 2017

Study Start

April 3, 2017

Primary Completion

April 5, 2018

Study Completion

November 5, 2018

Last Updated

October 11, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations