Condition or disease | Intervention/treatment | Phase |
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Healthy Volunteers High-level Sportsman | Device: Active tDCS Device: Sham tDCS | Not Applicable |
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 |
Arm | Intervention/treatment |
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Experimental: Group S1
High level jump practice : more 4000 hours of practice during the last five years
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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)
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Experimental: Group S2
Amateur jump practice : less 4000 hours of practice during the last five years
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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
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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)
|
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:
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.
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:
Each symptom is rated 0 to 3. The total score thus vary from 0 to 27.
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:
Each symptom is rated 0 to 3. The total score thus vary from 0 to 27.
Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
According to groups :
Part A :
Part B :
Exclusion Criteria:
Contact: Magali NICOLIER PALLANDRE, PhD | 00333 81 21 90 07 | mnicolier@chu-besancon.fr |
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 |
Principal Investigator: | Djamila BENNABI, MD | CHU de Besançon |
Tracking Information | |||||
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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 |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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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:
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:
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. |
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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 |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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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. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |
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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 |