Healthy VolunteersCOMPETENCT03937115
Effect of tDCS on Sport Performance for Two Categories of Athletes : Explosive Profile and Enduring Profile
A study testing Active tDCS in people with Healthy Volunteers and High-level Sportsman, run by Centre Hospitalier Universitaire de Besancon at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, High-level Sportsman
- What is being tested?
- Active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesFrance
- Study dates
- 21 Nov 2018to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 :
Show all 12Show fewer
- 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
Who cannot join
- 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"
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
CHU Besancon - Clinical Psychiatric Department
Besançon, 25000
Djamila BENNABI, MD PhD, +33381219007, dbennabi@chu-besancon.fr
Magali NICOLIER, PhD, +33381219007, mnicolier@chu-besancon.fr
- Recruiting
EA4660- C3S, Culture, Sport, Santé, Société
Besançon, 25000
Sidney Grospretre, PhD, sidney.grospretre@univ-fcomte.fr
About this study
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)
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.
Read the 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:
- Anode: F3 / Cathode: AF8/ Stimulation intensity: 2 mA
- Anode: F3/ Cathode: AF8/ Stimulation intensity: 0 mA
- 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.
- Conditions
- Healthy Volunteers, High-level Sportsman
- Being tested
- Active tDCS, Sham tDCS
- Keywords
- tDCS, Noninvasive brain stimulation, Endurance performance, Cognitive performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
Also called Starstim® (Neuroelectrics, Spain)
2 active tDCS sessions (20 min each, 2 mA) applied to the dlPFC and right motor cortex
Sham tDCSDevice
Also called Starstim® (Neuroelectrics, Spain)
1 sham tDCS session (20 min, 0 mA) applied to the dlPFC
Active tDCSDevice
Also called Starstim® (Neuroelectrics, Spain)
10 tDCS sessions (2 sessions/day for 5 days, 20 mA, 20 min each) applied to the dlPFC
Sham tDCSDevice
Also called Starstim® (Neuroelectrics, Spain)
10 tDCS sessions (2 sessions/day for 5 days, 0 mA, 20 min each) applied to the dlPFC
| Study group | Role | What they receive |
|---|---|---|
| Group S1 | Experimental | High level jump practice : more 4000 hours of practice during the last five years Receives: Device: Active tDCS; Device: Sham tDCS |
| Group S2 | Experimental | Amateur jump practice : less 4000 hours of practice during the last five years Receives: Device: Active tDCS; Device: Sham tDCS |
| Group C1 | Experimental | High level cycling practice: more 4000 hours of practice during the last five years Receives: Device: Active tDCS; Device: Sham tDCS |
| Group C2 | Experimental | Amateur cycling practice: less 4000 hours of practice during the last five years Receives: Device: Active tDCS; Device: Sham tDCS |
| Group T | Experimental | Sedentary : less two hours of recreationally practice of sport by week Receives: Device: Active tDCS; Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 5
Secondary outcomes (9)
Average power during the time trial before and after 10 tDCS sessions
Average power (in watts) measured during a 20min time trial before and after 10 tDCS sessions for 5 days
Measured: Day 35
BIS-10 scores
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.
Measured: Day 60
MCQ scores
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.
Measured: Day 60
Stroop task
Compared results from the experimental Stroop task, assessing response inhibition.
Measured: Day 60
Go/No-Go task
Compared results from the experimental Go/No-Go task, assessing response inhibition.
Measured: Day 60
Effort Expenditure for Reward Task
Compared results from the experimental Effort Expenditure for Reward Task, assessing motivation
Measured: Day 60
Balloon Analog Risk Task
Compared results from the experimental Balloon Analog Risk task, assessing impulsivity
Measured: Day 60
QIDS-C16 scale
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.
Measured: Day 60
QIDS-SR16 scale
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.
Measured: Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start21 Nov 2018
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Djamila BENNABI, MD, Principal investigator, CHU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937115
- Sponsor's protocol ID
- API/2018/97
- Acronym
- COMPETE
- Status last verified
- May 2019
- First submitted
- 6 Mar 2019
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Giancatarina M, Grandperrin Y, Nicolier M, Gimenez P, Vidal C, Tio G, Haffen E, Bennabi D, Grospretre S. Acute effect of transcranial direct current stimulation (tDCS) on postural control of trained athletes: A randomized controlled trial. PLoS One. 2024 Jan 18;19(1):e0286443. doi: 10.1371/journal.pone.0286443. eCollection 2024.
PubMed 38236903Grandperrin 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.
PubMed 32493462
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03937115
- Acronym / sponsor ID
- COMPETE / API/2018/97
- Conditions
- Healthy Volunteers, High-level Sportsman
- Keywords
- tDCS, Noninvasive brain stimulation, Endurance performance, Cognitive performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 3 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Anode: F3 / Cathode: AF8/ Stimulation intensity: 2 mA
- Anode: F3/ Cathode: AF8/ Stimulation intensity: 0 mA
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group S1 | Experimental | Device: Active tDCS, Device: Sham tDCSHigh level jump practice : more 4000 hours of practice during the last five years |
| Group S2 | Experimental | Device: Active tDCS, Device: Sham tDCSAmateur jump practice : less 4000 hours of practice during the last five years |
| Group C1 | Experimental | Device: Active tDCS, Device: Sham tDCSHigh level cycling practice: more 4000 hours of practice during the last five years |
| Group C2 | Experimental | Device: Active tDCS, Device: Sham tDCSAmateur cycling practice: less 4000 hours of practice during the last five years |
| Group T | Experimental | Device: Active tDCS, Device: Sham tDCSSedentary : less two hours of recreationally practice of sport by week |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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 :
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active tDCSAlso: Starstim® (Neuroelectrics, Spain)2 active tDCS sessions (20 min each, 2 mA) applied to the dlPFC and right motor cortex | Device | Group S1, Group S2 |
| Sham tDCSAlso: Starstim® (Neuroelectrics, Spain)1 sham tDCS session (20 min, 0 mA) applied to the dlPFC | Device | Group S1, Group S2 |
| Active tDCSAlso: Starstim® (Neuroelectrics, Spain)10 tDCS sessions (2 sessions/day for 5 days, 20 mA, 20 min each) applied to the dlPFC | Device | Group C1, Group C2, Group T |
| Sham tDCSAlso: Starstim® (Neuroelectrics, Spain)10 tDCS sessions (2 sessions/day for 5 days, 0 mA, 20 min each) applied to the dlPFC | Device | Group C1, Group C2, Group T |
Primary outcome
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
9 secondary outcomes
Average power during the time trial before and after 10 tDCS sessions
Time frame: Day 35
BIS-10 scores
Time frame: Day 60
MCQ scores
Time frame: Day 60
Stroop task
Time frame: Day 60
Go/No-Go task
Time frame: Day 60
Effort Expenditure for Reward Task
Time frame: Day 60
Balloon Analog Risk Task
Time frame: Day 60
QIDS-C16 scale
Time frame: Day 60
QIDS-SR16 scale
Time frame: Day 60
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Derived from this study: PubMed 38236903Giancatarina M, Grandperrin Y, Nicolier M, Gimenez P, Vidal C, Tio G, Haffen E, Bennabi D, Grospretre S. Acute effect of transcranial direct current stimulation (tDCS) on postural control of trained athletes: A randomized controlled trial. PLoS One. 2024 Jan 18;19(1):e0286443. doi: 10.1371/journal.pone.0286443. eCollection 2024.
- Derived from this study: PubMed 32493462Grandperrin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Djamila BENNABI, MD principal investigator
CHU de Besançon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS in people with Healthy Volunteers and High-level Sportsman, run by Centre Hospitalier Universitaire de Besancon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magali NICOLIER PALLANDRE, PhD (00333 81 21 90 07, mnicolier@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance (in meters) measured during jumps (time frame: Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03937115, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.