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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03157869
Other study ID # tDCS1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 3, 2017
Est. completion date November 5, 2018

Study information

Verified date October 2018
Source University of Sao Paulo General Hospital
Contact Maria Elisa P Piemonte, PhD
Phone 5511982082930
Email elisapp@usp.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Thirty-six young healthy individuals, right-handed, with no deficits that difficult the performance of the procedures will participate in the study. These individuals will be randomly divided into an experimental group that will perform the motor training of a sequential task of fingers simultaneously to the anodic tDCS on the contralateral motor cortex the trained hand and a control group that will perform the same training simultaneously the stimulation placebo (simulated in the same region of the experimental group). The training will consist of 8 blocks with 300 repetitions of sequential finger movements performed with only the right upper limb. The speed and accuracy 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. Appropriate statistical methods will be used to identify inter- and intra-group differences.


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date November 5, 2018
Est. primary completion date April 5, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Transcranial Direct Current Stimulation
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).
Other:
Simulated
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).

Locations

Country Name City State
Brazil Center of Research of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University São Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Accuracy The accuracy (number of errors in a minute) in the same way as described to Outcome 1 Up to 28 days
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