NCT03937115

Brief Summary

The study aims to compare the effects of tDCS applied on the dorsolateral prefrontal cortex (dlPFC) vs sham on the neuromuscular system. Two types of athletes will benefit from stimulation: jumper and cyclists. Short and long term effects are assesed by electromyographic records, experimental tasks and self-rated scales.

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
50

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

2 active sites

Status
unknown

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

Study Start

First participant enrolled

November 21, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 3, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

May 3, 2019

Status Verified

May 1, 2019

Enrollment Period

1.4 years

First QC Date

March 6, 2019

Last Update Submit

May 2, 2019

Conditions

Healthy VolunteersHigh-level Sportsman

Keywords

tDCSNoninvasive brain stimulationEndurance performanceCognitive performance

Outcome Measures

Primary Outcomes (1)

  • Performance (in meters) measured during jumps

    Performance measurement (in meters) during the three types of jumps (long jump, squat jump and countermovement jump) before and after tDCS session

    Day 5

Secondary Outcomes (9)

  • Average power during the time trial before and after 10 tDCS sessions

    Day 35

  • BIS-10 scores

    Day 60

  • MCQ scores

    Day 60

  • Stroop task

    Day 60

  • Go/No-Go task

    Day 60

  • +4 more secondary outcomes

Study Arms (5)

Group S1

EXPERIMENTAL

High level jump practice : more 4000 hours of practice during the last five years

Device: Active tDCSDevice: Sham tDCS

Group S2

EXPERIMENTAL

Amateur jump practice : less 4000 hours of practice during the last five years

Device: Active tDCSDevice: Sham tDCS

Group C1

EXPERIMENTAL

High level cycling practice: more 4000 hours of practice during the last five years

Device: Active tDCSDevice: Sham tDCS

Group C2

EXPERIMENTAL

Amateur cycling practice: less 4000 hours of practice during the last five years

Device: Active tDCSDevice: Sham tDCS

Group T

EXPERIMENTAL

Sedentary : less two hours of recreationally practice of sport by week

Device: Active tDCSDevice: Sham tDCS

Interventions

Active tDCSDEVICE

2 active tDCS sessions (20 min each, 2 mA) applied to the dlPFC and right motor cortex

Also known as: Starstim® (Neuroelectrics, Spain)
Group S1Group S2
Sham tDCSDEVICE

1 sham tDCS session (20 min, 0 mA) applied to the dlPFC

Also known as: Starstim® (Neuroelectrics, Spain)
Group S1Group S2

Eligibility Criteria

Age18 Years - 100 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Man older than 18 years old
  • Right-handed
  • Signed informed Consent form
  • Subject affiliated to or beneficing from a French social security regime
  • According to groups :
  • Part A :
  • Group S1 : High level jump practice : more 4000 hours of practice during the last five years
  • Group S2 : Amateur jump practice : less 4000 hours of practice during the last five years
  • Part B :
  • Group C1 : High level cycling practice: more 4000 hours of practice during the last five years
  • Group C2 : Amateur cycling practice: less 4000 hours of practice during the last five years
  • Group T : Sedentary : less two hours of recreationally practice of sport by week

You may not qualify if:

  • Younger than18 years old
  • Left-handed
  • Subject under measure of protection or guardianship of justice
  • Subject beneficiary from a legal protection regime
  • Subject unlikely to cooperate or low cooperation stated by investigator
  • Subject not covered by social security
  • Suject with comorbidities : addictive (except : tea, coffee, tobacco), psychiatric, severe somatic pathologies (specially tumors, degenerative disease) or progressive neurologic pathologie

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Besancon - Clinical Psychiatric Department

Besançon, 25000, France

RECRUITING

EA4660- C3S, Culture, Sport, Santé, Société

Besançon, 25000, France

RECRUITING

Related Publications (1)

  • Grandperrin Y, Grospretre S, Nicolier M, Gimenez P, Vidal C, Haffen E, Bennabi D. Effect of transcranial direct current stimulation on sports performance for two profiles of athletes (power and endurance) (COMPETE): a protocol for a randomised, crossover, double blind, controlled exploratory trial. Trials. 2020 Jun 3;21(1):461. doi: 10.1186/s13063-020-04412-0.

    PMID: 32493462DERIVED

Study Officials

  • Djamila BENNABI, MD

    CHU de Besançon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Magali NICOLIER PALLANDRE, PhD

CONTACT

00333 81 21 90 07mnicolier@chu-besancon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2019

First Posted

May 3, 2019

Study Start

November 21, 2018

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

May 3, 2019

Record last verified: 2019-05

Locations

FR(2)