NCT02557841

Brief Summary

A crossover trial with healthy volunteers will be conducted. Three sessions will be performed with at least 48 hours washout period to minimize carry-over effects. In each session, volunteers will be submitted to: fatigue and attention levels evaluation, handwriting test, serial reaction time task (SRTT) before and after ctDCS conditions and after session, a performance perception evaluation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

September 1, 2015

Last Update Submit

October 11, 2018

Conditions

Keywords

CerebellumTranscranial Direct Current StimulationMotor LearningSerial Reaction Time TaskHandwriting

Outcome Measures

Primary Outcomes (1)

  • Changes on implicit motor learning

    Serial reaction time task evaluates implicit motor learning through software with visual stimuli presented on a computer screen in four different positions. Volunteer must press, with the non-dominant hand, a corresponding key with predetermined fingers as soon as possible when a highlighted star appears on the screen. The test comprises eight blocks with 120 trials each.

    One week (before and after ctDCS)

Secondary Outcomes (3)

  • Changes on fatigue levels

    One week (before and after ctDCS)

  • Changes on attention levels

    One week (before and after ctDCS)

  • Changes on explicit motor learning

    One week (before and after ctDCS)

Other Outcomes (2)

  • Changes on performance perception

    One week (after each session)

  • Cerebellar tDCS adverse effects

    One week (after each session)

Study Arms (3)

anodal ctDCS

EXPERIMENTAL

Volunteers will be submitted to anodal ctDCS + motor learning assessments (SRTT and Handwriting test).

Device: tDCS

cathodal ctDCS

EXPERIMENTAL

Volunteers will be submitted to cathodal ctDCS + motor learning assessments (SRTT and Handwriting test).

Device: tDCS

sham ctDCS

SHAM COMPARATOR

Volunteers will be submitted to sham ctDCS + motor learning assessments (SRTT and Handwriting test)

Device: tDCS

Interventions

tDCSDEVICE

Current will be applied by a DC stimulator (NeuroConn Plus, Germany).The active electrode (anode: 5x7 cm²) will be placed over the left cerebellar hemisphere (3 cm lateral to the inion) and the reference (5x7 cm²), over the left arm with current intensity of 2mA, fade in and fade out of 10 seconds, during 20 minutes.

anodal ctDCS

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Right-handed (assessed by Edinburgh Handedness Inventory)
  • Healthy volunteers (self report)
  • Absence of neurological and psychiatric diseases
  • No history of severe musculoskeletal injury on wrists and fingers
  • Without using drugs or neuroactive substances regularly

You may not qualify if:

  • Pregnancy
  • Presence of metallic implant in close contact to the target stimulation area
  • Acute eczema under the target stimulation area
  • Pacemaker
  • History of seizures or epilepsy
  • Hemodynamic instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Applied Neuroscience Laboratory, Universidade Federal de Pernambuco

Recife, Pernambuco, 50670-900, Brazil

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Kátia K Monte-Silva, PhD

    Universidade Federal de Pernambuco

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 1, 2015

First Posted

September 23, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

October 12, 2018

Record last verified: 2018-10

Locations