Non-invasive Cerebellar Stimulation on Motor Learning

NCT02559518 | Completed DMC

• 1 other identifier: Cerebellum_MotorLearning
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

A crossover trial with healthy volunteers will be conducted. Six sessions will be performed once a week in a counterbalanced order and at least with seven days washout period to minimize carry-over effects. In each session, volunteers will be submitted to: fatigue and attention levels evaluation, cortical brain activity measures through paired pulse transcranial magnetic stimulation (pp-TMS), handwriting test, non-invasive cerebellar stimulation during serial reaction time task (SRTT) and performance perception evaluation.

Conditions

Healthy

Keywords

Cerebellum; Transcranial Direct Current Stimulation; Repetitive Transcranial Magnetic Stimulation; Motor Learning; Serial Reaction Time Task; HandwritingTask

Outcome Measures

Primary Outcomes (1)

• Changes on implicit motor learning

  Serial reaction time task will be performed during stimulation protocol and will evaluate 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.

  Six weeks (during stimulation protocol)

Secondary Outcomes (2)

• Changes on cortical brain activity (Intracortical inhibition and facilitation)

  Six weeks (before and after stimulation protocol)

• Changes on explicit motor learning

  Six weeks (before and after stimulation protocol)

Other Outcomes (4)

• Changes on fatigue levels

  Six weeks (before and after stimulation protocol)

• Changes on performance perception

  Six weeks (after each session)

• Cerebellar stimulation adverse effects

  Six weeks (after each session)

Study Arms (6)

anodal ctDCS

EXPERIMENTAL

Volunteers will be submitted to non-invasive cerebellar stimulation during serial reaction time task (SRTT).

Device: tDCS; Device: pp-TMS assessment

cathodal ctDCS

EXPERIMENTAL

Volunteers will be submitted to non-invasive cerebellar stimulation during serial reaction time task (SRTT).

Device: tDCS; Device: pp-TMS assessment

sham ctDCS

SHAM COMPARATOR

Volunteers will be submitted to non-invasive cerebellar stimulation during serial reaction time task (SRTT).

Device: tDCS; Device: pp-TMS assessment

high frequency c-rTMS

EXPERIMENTAL

Volunteers will be submitted to non-invasive cerebellar stimulation during serial reaction time task (SRTT).

Device: rTMS; Device: pp-TMS assessment

low frequency c-rTMS

EXPERIMENTAL

Volunteers will be submitted to non-invasive cerebellar stimulation during serial reaction time task (SRTT).

Device: rTMS; Device: pp-TMS assessment

sham c-rTMS

SHAM COMPARATOR

Volunteers will be submitted to non-invasive cerebellar stimulation during serial reaction time task (SRTT).

Device: rTMS; Device: pp-TMS assessment

Interventions

tDCS DEVICE

Current will be applied by a DC stimulator (NeuroConn Plus, Germany).The active electrode (anode: 5x5 cm²) will be placed over the left cerebellar hemisphere (3 cm lateral to the inion) and the reference (5x7 cm²), over the right arm with current intensity of 2mA, fade in and fade out of 10 seconds, during 20 minutes.

anodal ctDCS

rTMS DEVICE

High frequency c-rTMS will be applied through a figure-eight coil connected to a magnetic stimulator (Rapid², Magstim, UK) placed over the left cerebellar hemisphere (3 cm lateral to the inion), tangentially to the scalp and pointing upwards. Protocol: 10Hz, 110% RMT, 33 trains, 50 stimuli per train, intertrain interval of 25 seconds, 1650 stimuli.

high frequency c-rTMS

pp-TMS assessment DEVICE

SICI and ICF will be evaluated through pp-TMS. Subthreshold conditioning stimuli (80% of RMT) and suprathreshold test stimuli (120% of RMT) will be delivered at 2 milliseconds ISI, in order to determine SICI. ICF will be evaluated by MEP average at an ISI of 10 milliseconds. Ten stimuli will be applied at each condition (unconditioned pulse and pairs of stimuli with ISI of 2 and 10 milliseconds). Stimuli order delivery will be pseudo-randomized and SICI and ICF will be expressed as conditioned stimulus percentage regarding an unconditioned stimulus.

anodal ctDCS; cathodal ctDCS; high frequency c-rTMS; low frequency c-rTMS; sham c-rTMS; sham ctDCS

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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 to wrists and fingers
• Without using drugs or neuroactive substances regularly

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Applied Neuroscience Laboratory

Recife, Pernambuco, 50670-900, Brazil

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological 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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• 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 24, 2015
• Study Start: September 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 12, 2018

Record last verified: 2018-10

Locations

BR (1)