NCT03901222

Brief Summary

Relatively high level athletes will undergo 2 randomized, cross-over counterbalanced sessions of bi-anodal tDCS (transcranial direct current stimulation) or sham tDCS The primary outcome is a 3D evaluation coupled with EMG (Electromyography) of their primary lower limb muscles after each session

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Mar 2019

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

March 31, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

March 28, 2019

Last Update Submit

March 30, 2020

Conditions

Keywords

tDCSAthleteEnduranceFatigue3D

Outcome Measures

Primary Outcomes (4)

  • Peak Height

    Peak height (measured by the 3D device) is measured after each of the 30 repetitions as well as after the 3 jumps before and after tDCS. Height decrease will also be looked at

    Changes between Prior and Immediately Following tDCS and Sham

  • Gluteal EMG (Electromyography) recordings (% of maximal EMG value)

    Bilateral Gluteal EMG

    Changes between Prior and Immediately Following tDCS and Sham

  • Quadriceps EMG (Electromyography) recordings (% of maximal EMG value)

    Bilateral Quadriceps EMG triceps surae will be measured

    Changes between Prior and Immediately Following tDCS and Sham

  • Triceps EMG (Electromyography) recordings (% of maximal EMG value)

    Bilateral Triceps Surae EMG

    Changes between Prior and Immediately Following tDCS and Sham

Study Arms (2)

Bi-Anodal tDCS

ACTIVE COMPARATOR

Subjects will receive 20 min of bi-anodal tDCS

Device: tDCS

Sham tDCS

SHAM COMPARATOR

Subjects will receive 20 minutes of Sham anodal tDCS

Device: tDCS

Interventions

tDCSDEVICE

20 minutes of anodal tDCS (C3 \& C4/FPZ) 2mA or sham

Also known as: Non invasive brain stimulation
Bi-Anodal tDCSSham tDCS

Eligibility Criteria

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

You may qualify if:

  • At least 10 hours of sport a week
  • Right handed and footed

You may not qualify if:

  • One on the TSST (in high and relatively high risk sections)
  • Previous neurological or orthopedic pathologies affecting limbs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liege Univeristy Hospital

Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Fatigue

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Stephen Bornheim, Msc

    Liege University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The device is preprogrammed by a third party non participating in any element in the study. They then chose (using opaque envelopes) the treatment code for each participant
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Randomized, triple-blind, sham-controlled, crossover
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 28, 2019

First Posted

April 3, 2019

Study Start

March 31, 2019

Primary Completion

July 31, 2019

Study Completion

August 31, 2019

Last Updated

March 31, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations