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出境医 / 临床实验 / Effect of tDCS on Sport Performance for Two Categories of Athletes : Explosive Profile and Enduring Profile (COMPETE)

Effect of tDCS on Sport Performance for Two Categories of Athletes : Explosive Profile and Enduring Profile (COMPETE)

Study Description
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers High-level Sportsman Device: Active tDCS Device: Sham tDCS Not Applicable

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Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Effets de la tDCS Sur la Performance Sportive de 2 Profils d'athlètes : Explosifs (Sauteurs de Haut Niveau et Amateur) et Endurants (Cyclistes de Haut Niveau et Amateur)
Actual Study Start Date : November 21, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Group S1
High level jump practice : more 4000 hours of practice during the last five years
Device: Active tDCS
2 active tDCS sessions (20 min each, 2 mA) applied to the dlPFC and right motor cortex
Other Name: Starstim® (Neuroelectrics, Spain)

Device: Sham tDCS
1 sham tDCS session (20 min, 0 mA) applied to the dlPFC
Other Name: Starstim® (Neuroelectrics, Spain)

Experimental: Group S2
Amateur jump practice : less 4000 hours of practice during the last five years
Device: Active tDCS
2 active tDCS sessions (20 min each, 2 mA) applied to the dlPFC and right motor cortex
Other Name: Starstim® (Neuroelectrics, Spain)

Device: Sham tDCS
1 sham tDCS session (20 min, 0 mA) applied to the dlPFC
Other Name: Starstim® (Neuroelectrics, Spain)

Experimental: Group C1
High level cycling practice: more 4000 hours of practice during the last five years
Device: Active tDCS
10 tDCS sessions (2 sessions/day for 5 days, 20 mA, 20 min each) applied to the dlPFC
Other Name: Starstim® (Neuroelectrics, Spain)

Device: Sham tDCS
10 tDCS sessions (2 sessions/day for 5 days, 0 mA, 20 min each) applied to the dlPFC
Other Name: Starstim® (Neuroelectrics, Spain)

Experimental: Group C2
Amateur cycling practice: less 4000 hours of practice during the last five years
Device: Active tDCS
10 tDCS sessions (2 sessions/day for 5 days, 20 mA, 20 min each) applied to the dlPFC
Other Name: Starstim® (Neuroelectrics, Spain)

Device: Sham tDCS
10 tDCS sessions (2 sessions/day for 5 days, 0 mA, 20 min each) applied to the dlPFC
Other Name: Starstim® (Neuroelectrics, Spain)

Experimental: Group T
Sedentary : less two hours of recreationally practice of sport by week
Device: Active tDCS
10 tDCS sessions (2 sessions/day for 5 days, 20 mA, 20 min each) applied to the dlPFC
Other Name: Starstim® (Neuroelectrics, Spain)

Device: Sham tDCS
10 tDCS sessions (2 sessions/day for 5 days, 0 mA, 20 min each) applied to the dlPFC
Other Name: Starstim® (Neuroelectrics, Spain)

Outcome Measures
Primary Outcome Measures :
  1. Performance (in meters) measured during jumps [ Time Frame: Day 5 ]
    Performance measurement (in meters) during the three types of jumps (long jump, squat jump and countermovement jump) before and after tDCS session


Secondary Outcome Measures :
  1. Average power during the time trial before and after 10 tDCS sessions [ Time Frame: Day 35 ]
    Average power (in watts) measured during a 20min time trial before and after 10 tDCS sessions for 5 days

  2. BIS-10 scores [ Time Frame: Day 60 ]
    Compared scores from the French version of the Barratt Impulsiveness Scale (BIS-10). The French version of the BIS-10 is a self-rated 34 item questionnaire, composed by three subscales: motor-impulsivity, cognitive-impulsivity and non-planning-impulsivity. Each item is scored on a 0 to 4 points scale. Higher scores indicate higher levels of impulsivity.

  3. MCQ scores [ Time Frame: Day 60 ]

    Compared scores from the French version of the Monetary Choice Questionnaire. The MCQ is a self-rated 27 item questionnaire which assessed the discounting. Delay discounting is the decline in the present value of a reward with delay to its receipt.

    Example item: " Would you prefer 25€ today or 75€ in 15 days? "

    For each item, subjects must choose between a low immediate reward and a higher delayed reward.

    Waiting times vary from 7 days to 186 days, and rewards are divides into 3 magnitudes: low (25-35€), medium (50-60€), high (75-85€).

    This will allow assessing:

    • the influence of the the magnitude of the difference between the two rewards proposed,
    • the impact of the time on the reward's subjective value (speed at which the reward is devalued over time), reflected in the k index.

    This index is calculated separately for each magnitude, and an average index is calculated for each subject.

    The more the k index is high, the more the subject is considered impulsive.


  4. Stroop task [ Time Frame: Day 60 ]
    Compared results from the experimental Stroop task, assessing response inhibition.

  5. Go/No-Go task [ Time Frame: Day 60 ]
    Compared results from the experimental Go/No-Go task, assessing response inhibition.

  6. Effort Expenditure for Reward Task [ Time Frame: Day 60 ]
    Compared results from the experimental Effort Expenditure for Reward Task, assessing motivation

  7. Balloon Analog Risk Task [ Time Frame: Day 60 ]
    Compared results from the experimental Balloon Analog Risk task, assessing impulsivity

  8. QIDS-C16 scale [ Time Frame: Day 60 ]

    Compared scores from the French version of the Quick Inventory of Depressive Symptomatology. The QIDS-C16 is a 16 item questionnaire completed by the clinician to assess the depressive symptomatology and the severity of the depression.

    These 16 items are constructed around the 9 following symptoms:

    • sad mood,
    • concentration,
    • autocriticism,
    • suicidal thoughts,
    • ahnedonia,
    • fatigue,
    • sleep disorders,
    • appetite/weight changes,
    • psychomotor retardation/agitation. This scaled is based on the intensity of each symptom in the 7 last days, regardless of its chronicity or its recent apparition.

    Each symptom is rated 0 to 3. The total score thus vary from 0 to 27.


  9. QIDS-SR16 scale [ Time Frame: Day 60 ]

    Compared scores from the French version of the Quick Inventory of Depressive Symptomatology. The QIDS-SR16 is a self-rated 16 item questionnaire, assessing the intensity of depressive symptomatology.

    These 16 items are constructed around the 9 following symptoms:

    • sad mood,
    • concentration,
    • autocriticism,
    • suicidal thoughts,
    • ahnedonia,
    • fatigue,
    • sleep disorders,
    • appetite/weight changes,
    • psychomotor retardation/agitation. This scaled is based on the intensity of each symptom in the 7 last days, regardless of its chronicity or its recent apparition.

    Each symptom is rated 0 to 3. The total score thus vary from 0 to 27.



Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Subject being in the exclusion period of another study or provided for by the "National Volunteer File"
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Magali NICOLIER PALLANDRE, PhD 00333 81 21 90 07 mnicolier@chu-besancon.fr

Locations
Layout table for location information
France
CHU Besancon - Clinical Psychiatric Department Recruiting
Besancon, France, 25000
Contact: Djamila BENNABI, MD PhD    +33381219007    dbennabi@chu-besancon.fr   
Contact: Magali NICOLIER, PhD    +33381219007    mnicolier@chu-besancon.fr   
Principal Investigator: Djamila BENNABI, MD PhD         
EA4660- C3S, Culture, Sport, Santé, Société Recruiting
Besançon, France, 25000
Contact: Sidney Grospretre, PhD       sidney.grospretre@univ-fcomte.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
Layout table for investigator information
Principal Investigator: Djamila BENNABI, MD CHU de Besançon
Tracking Information
First Submitted Date  ICMJE March 6, 2019
First Posted Date  ICMJE May 3, 2019
Last Update Posted Date May 3, 2019
Actual Study Start Date  ICMJE November 21, 2018
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
Performance (in meters) measured during jumps [ Time Frame: Day 5 ]
Performance measurement (in meters) during the three types of jumps (long jump, squat jump and countermovement jump) before and after tDCS session
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
  • Average power during the time trial before and after 10 tDCS sessions [ Time Frame: Day 35 ]
    Average power (in watts) measured during a 20min time trial before and after 10 tDCS sessions for 5 days
  • BIS-10 scores [ Time Frame: Day 60 ]
    Compared scores from the French version of the Barratt Impulsiveness Scale (BIS-10). The French version of the BIS-10 is a self-rated 34 item questionnaire, composed by three subscales: motor-impulsivity, cognitive-impulsivity and non-planning-impulsivity. Each item is scored on a 0 to 4 points scale. Higher scores indicate higher levels of impulsivity.
  • MCQ scores [ Time Frame: Day 60 ]
    Compared scores from the French version of the Monetary Choice Questionnaire. The MCQ is a self-rated 27 item questionnaire which assessed the discounting. Delay discounting is the decline in the present value of a reward with delay to its receipt. Example item: " Would you prefer 25€ today or 75€ in 15 days? " For each item, subjects must choose between a low immediate reward and a higher delayed reward. Waiting times vary from 7 days to 186 days, and rewards are divides into 3 magnitudes: low (25-35€), medium (50-60€), high (75-85€). This will allow assessing:
    • the influence of the the magnitude of the difference between the two rewards proposed,
    • the impact of the time on the reward's subjective value (speed at which the reward is devalued over time), reflected in the k index.
    This index is calculated separately for each magnitude, and an average index is calculated for each subject. The more the k index is high, the more the subject is considered impulsive.
  • Stroop task [ Time Frame: Day 60 ]
    Compared results from the experimental Stroop task, assessing response inhibition.
  • Go/No-Go task [ Time Frame: Day 60 ]
    Compared results from the experimental Go/No-Go task, assessing response inhibition.
  • Effort Expenditure for Reward Task [ Time Frame: Day 60 ]
    Compared results from the experimental Effort Expenditure for Reward Task, assessing motivation
  • Balloon Analog Risk Task [ Time Frame: Day 60 ]
    Compared results from the experimental Balloon Analog Risk task, assessing impulsivity
  • QIDS-C16 scale [ Time Frame: Day 60 ]
    Compared scores from the French version of the Quick Inventory of Depressive Symptomatology. The QIDS-C16 is a 16 item questionnaire completed by the clinician to assess the depressive symptomatology and the severity of the depression. These 16 items are constructed around the 9 following symptoms:
    • sad mood,
    • concentration,
    • autocriticism,
    • suicidal thoughts,
    • ahnedonia,
    • fatigue,
    • sleep disorders,
    • appetite/weight changes,
    • psychomotor retardation/agitation. This scaled is based on the intensity of each symptom in the 7 last days, regardless of its chronicity or its recent apparition.
    Each symptom is rated 0 to 3. The total score thus vary from 0 to 27.
  • QIDS-SR16 scale [ Time Frame: Day 60 ]
    Compared scores from the French version of the Quick Inventory of Depressive Symptomatology. The QIDS-SR16 is a self-rated 16 item questionnaire, assessing the intensity of depressive symptomatology. These 16 items are constructed around the 9 following symptoms:
    • sad mood,
    • concentration,
    • autocriticism,
    • suicidal thoughts,
    • ahnedonia,
    • fatigue,
    • sleep disorders,
    • appetite/weight changes,
    • psychomotor retardation/agitation. This scaled is based on the intensity of each symptom in the 7 last days, regardless of its chronicity or its recent apparition.
    Each symptom is rated 0 to 3. The total score thus vary from 0 to 27.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of tDCS on Sport Performance for Two Categories of Athletes : Explosive Profile and Enduring Profile
Official Title  ICMJE Effets de la tDCS Sur la Performance Sportive de 2 Profils d'athlètes : Explosifs (Sauteurs de Haut Niveau et Amateur) et Endurants (Cyclistes de Haut Niveau et Amateur)
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.
Detailed Description

Transcranial direct current stimulation is a technique of noninvasive brain stimulation which delivers a electrical current to the scalp to modulate the neuronal activity. Depending on the polarity of stimulation, tDCS induces a neural hyperexcitability (with anode) or hypoexcitability (with cathode) of the target area.

Due to its neuromodulatory action, ease of use and low safety, tDCS can be used as a potential treatment but also as an investigative tool in neurophysiology. Thus, studies have shown a beneficial effect of tDCS on cognitive and motor functions. Nevertheless, studies conducted on motor performance and the reduction of neuromuscular fatigue show disparate results. It is impossible to conclude whether tDCS allows for improved performance and is a means of doping.

With a prospective, sham-controlled, crossover, double-blind design, this study aims to evaluate the effect of tDCS on neuromuscular fatigue resistance during explosive (jumping) and endurance (cycling) exertion.

This study is divided into two parts:

  • Part A: jumping group
  • Part B: cycling group.

During Part A, participants visit the laboratory on 3 occasions. Each visit is organized in the same way and is at least 48 hours apart from the previous one.

Participants are divided into two groups according to their level of experience (amateurs vs. high level).

Before the session of tDCS, participants carry out a psychometric assessment (MCQ, BIS10) and experimental tasks (BART, EEFRT, STROOP test and Go NoGo task). Then, they performed three types of jumps (long jump, squat jump and countermovement jump). Finally, participants benefit from neuromuscular tests (EMG recording of plantar flexor muscle activity, percutaneous stimulation of the posterior tibial nerve).

Subjects will be submitted to three sessions of tDCS (2 actives and one sham), one by visit, in the order of randomization. Current intensity will be of 2 mA (or 0 mA), through 25 cm² surface electrodes, during 20 minutes. The positioning of the stimulation electrodes will be carried out in compliance with EEG 10/20 standards:

- Sequence order determined by randomization:

  1. Anode: F3 / Cathode: AF8/ Stimulation intensity: 2 mA
  2. Anode: F3/ Cathode: AF8/ Stimulation intensity: 0 mA
  3. Anode: FC2/ Cathode: Left shoulder/ Stimulation intensity: 2 mA

Immediately after the stimulation, participants perform motor and cognitive task again and the results are compared.

During part B, subjects participate in two training sessions of five days each. The training sessions are one month apart.

Participants are divided into three groups according to their level of experience (amateurs vs. high level vs. sedentary).

Each day, the subjects perform two twenty-minute time trials during which they receive a session of tDCS. (one week with the active tDCS, one week with the sham). So, subjects will be submitted to 10 tDCS stimulation sessions (active or sham) for five consecutive days (2 sessions of 20 minutes/day). Current intensity will be of 2 mA, through 25 cm² surface electrodes, placed over the dlPFC and the supraorbital region (anode position over F3 and cathode over AF8, according to the EEG 10-20 international system).

At J1 and J5 of each session (before and after session training), subjects carry out a psychometric assessment (MCQ, BIS10) and experimental tasks (BART, EEFRT, STROOP test and Go NoGo task) and benefit from neuromusculars tests (EMG recording of plantar flexor muscle activity, percutaneous stimulation of the posterior tibial nerve). Baseline measures will be compared to those obtained immediately after the end of sessions (5 days: short-term effects), and to 12 and 30 days later (long-term effects). Active and sham stimulation sessions outcomes will as well be compared.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Condition  ICMJE
  • Healthy Volunteers
  • High-level Sportsman
Intervention  ICMJE
  • Device: Active tDCS
    2 active tDCS sessions (20 min each, 2 mA) applied to the dlPFC and right motor cortex
    Other Name: Starstim® (Neuroelectrics, Spain)
  • Device: Sham tDCS
    1 sham tDCS session (20 min, 0 mA) applied to the dlPFC
    Other Name: Starstim® (Neuroelectrics, Spain)
  • Device: Active tDCS
    10 tDCS sessions (2 sessions/day for 5 days, 20 mA, 20 min each) applied to the dlPFC
    Other Name: Starstim® (Neuroelectrics, Spain)
  • Device: Sham tDCS
    10 tDCS sessions (2 sessions/day for 5 days, 0 mA, 20 min each) applied to the dlPFC
    Other Name: Starstim® (Neuroelectrics, Spain)
Study Arms  ICMJE
  • Experimental: Group S1
    High level jump practice : more 4000 hours of practice during the last five years
    Interventions:
    • Device: Active tDCS
    • Device: Sham tDCS
  • Experimental: Group S2
    Amateur jump practice : less 4000 hours of practice during the last five years
    Interventions:
    • Device: Active tDCS
    • Device: Sham tDCS
  • Experimental: Group C1
    High level cycling practice: more 4000 hours of practice during the last five years
    Interventions:
    • Device: Active tDCS
    • Device: Sham tDCS
  • Experimental: Group C2
    Amateur cycling practice: less 4000 hours of practice during the last five years
    Interventions:
    • Device: Active tDCS
    • Device: Sham tDCS
  • Experimental: Group T
    Sedentary : less two hours of recreationally practice of sport by week
    Interventions:
    • Device: Active tDCS
    • Device: Sham tDCS
Publications * Grandperrin Y, Grosprêtre 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 2, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Subject being in the exclusion period of another study or provided for by the "National Volunteer File"
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03937115
Other Study ID Numbers  ICMJE API/2018/97
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire de Besancon
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Besancon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Djamila BENNABI, MD CHU de Besançon
PRS Account Centre Hospitalier Universitaire de Besancon
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP