Transcranial Direct Current StimulationNCT06472882
Impact of Transcranial Direct Current Stimulation on the Capacity to Perform Burpees
A study testing tDCS targeting DLPFC and tDCS targeting M1 in people with Transcranial Direct Current Stimulation and Dorsolateral Prefrontal Cortex, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
Introduction and Background: Transcranial direct current stimulation (tDCS) has emerged as a potential intervention to improve physical performance. The primary aim of this study is to investigate the effects of tDCS applied to the primary motor cortex (M1) and dorsolateral prefrontal cortex (DLPFC) on performance in… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Transcranial Direct Current Stimulation, Dorsolateral Prefrontal Cortex, Primary Motor Cortex
- What is being tested?
- tDCS targeting DLPFC and tDCS targeting M1
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 6 Jan 2024to 15 Apr 2024
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subject.
- No use of any ergogenic substance.
- Participants must be recreationally active, defined as engaging in moderate physical activity at least 3 times per week for the past 6 months
Who cannot join
- Any contraindications to transcranial Direct Current Stimulation, such as metallic implants in the head, active implanted medical devices (e.g., pacemakers), or skin conditions affecting the scalp.
- Current or recent (within the past 6 months) substance abuse, including alcohol or recreational drugs.
- Musculoskeletal injury within the past 6 weeks.
- Lower extremity pain above 3 or more according to numeric pain scale.
- History of epilepsy or convulsive crisis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Transcranial Direct Current Stimulation on the Capacity to Perform Burpees: a Randomized Controlled Trial
Introduction and Background:
Transcranial direct current stimulation (tDCS) has emerged as a potential intervention to improve physical performance. The primary aim of this study is to investigate the effects of tDCS applied to the primary motor cortex (M1) and dorsolateral prefrontal cortex (DLPFC) on performance in a maximal effort task, specifically the No Jump Burpee exercise.
Read more
Study Design:
This study will utilize a double-blind crossover design, where each subject will complete three experimental conditions: a-DLPFC, a-M1, and SHAM.
Participants:
Twenty healthy male subjects will be recruited for the study.
Intervention:
Each participant will undergo three conditions in a randomized order:
a-DLPFC: tDCS applied to the dorsolateral prefrontal cortex.
a-M1: tDCS applied to the primary motor cortex. SHAM: Placebo stimulation.
Procedure:
Prior to performing the No Jump Burpee exercise to exhaustion, tDCS will be administered at a current of 2 milliampere (mA) for 20 minutes.
Measurements:
The following variables will be measured during the exercise:
Total number of repetitions of the No Jump Burpee exercise. Vastus lateralis muscle oxygen saturation. Heart rate. Subjective perception of exertion (RPE).
Data Analysis:
Repeated measures ANOVAs will be used to analyze the effects of the different tDCS conditions on the performance outcomes.
Ethical Considerations:
The study protocol will be reviewed and approved by an appropriate ethics committee. Written informed consent will be obtained from all participants before participation in the study.
Objectives:
The primary objective is to evaluate the impact of tDCS on physical performance, specifically measuring the total number of repetitions of the No Jump Burpee exercise. Secondary objectives include assessing the changes in muscle oxygen saturation, heart rate, and subjective perception of exertion.
- Conditions
- Transcranial Direct Current Stimulation, Dorsolateral Prefrontal Cortex, Primary Motor Cortex
- Being tested
- tDCS targeting DLPFC, tDCS targeting M1, SHAM tDCS
- Keywords
- Primary motor cortex, dorsolateral prefrontal cortex, physical endurance, tDCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS targeting DLPFCDevice
The anodic electrode will be placed on the left DLPFC (area F3) and the cathode on the right orbitofrontal cortex (area Fp2). Participants will receive 20 minutes of tDCS at 2 mA while seated.
tDCS targeting M1Device
The anodes will be placed over C3 and C4 (according to EEG 10-20 system), and the cathodes over the ipsilateral shoulders. Participants will receive 20 minutes of tDCS at 2 mA while seated.
SHAM tDCSDevice
The electrodes will be placed as in the other conditions, but the stimulation will be switched off after 30 seconds, providing an initial stinging sensation without continuous stimulation.
| Study group | Role | What they receive |
|---|---|---|
| tDCS Targeting the Dorsolateral Prefrontal Cortex (DLPFC) | Experimental | Participants in this arm will receive transcranial Direct Current Stimulation (tDCS) targeting the DLPFC. The tDCS will be administered at an intensity of 2 mA for 20 minutes. This arm aims to evaluate the effects of DLPFC stimulation on performance during a maximal effort "No Jump Burpee" exercise. Receives: Device: tDCS targeting DLPFC |
| tDCS Targeting the Primary Motor Cortex (M1) | Experimental | Participants in this arm will receive transcranial Direct Current Stimulation (tDCS) targeting the primary motor cortex (M1). The tDCS will be administered at an intensity of 2 mA for 20 minutes. This arm aims to evaluate the effects of M1 stimulation on performance during a maximal effort "No Jump Burpee" exercise. Receives: Device: tDCS targeting M1 |
| SHAM tDCS | Sham comparator | Participants in this arm will receive a sham tDCS session, which simulates the experience of tDCS without actual stimulation. This arm serves as a control to ensure the blinding of participants and evaluators. Receives: Device: SHAM tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of "No Jump Burpees" to Exhaustion
The primary objective of the study is to measure the number of repetitions of the "No Jump Burpee" exercise that participants can perform until exhaustion. This exercise is performed at a cadence of 20 burpees per minute, and exhaustion is determined when the participant can no longer maintain the correct pace or technique.
Measured: Measured immediately at the end of each experimental session (DLPFC, M1, SHAM), approximately 5-10 minutes after the start of the test..
Secondary outcomes (3)
Rating of Perceived Exertion (RPE)
Assessment of perceived exertion using the Borg CR10 scale, measured every 20 seconds during exercise.
Measured: Measured every 20 seconds during exercise, from the start until the participant reaches exhaustion, approximately 5-15 minutes per session.
Muscle Oxygen Saturation in the Vastus Lateralis
Continuous measurement of muscle oxygen saturation (SmO2) using a near-infrared spectroscopy (NIRS) device.
Measured: Measured continuously at a frequency of 1 Hz during the exercise, from the start until the participant reaches exhaustion, approximately 5-15 minutes per session.
Heart Rate During Exercise
Continuous measurement of heart rate during the performance of the "No Jump Burpee" exercise until exhaustion.
Measured: Measured continuously on a beat-by-beat basis during the exercise, from the start until the participant reaches exhaustion, approximately 5-15 minutes per session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start6 Jan 2024
- Primary completion8 Mar 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Direct Current StimulationStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study applied a double-blind, crossover design to examine the viability of tDCS in improving performance during a maximal effort task, particularly the "No Jump Burpee" exercise.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Collaborators
- University of A Coruna, La Coruna, Spain
- Responsible party
- Principal investigator, Salvador Romero Arenas, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472882
- Sponsor's protocol ID
- CE-031908-A
- Other IDs
- PID2021-128204OA-I00-AEI/FEDER, ED431B 2021/28
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Transcranial Direct Current Stimulation on the Capacity to Perform Burpees: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06472882
- Acronym / sponsor ID
- CE-031908-A
- Conditions
- Transcranial Direct Current Stimulation, Dorsolateral Prefrontal Cortex, Primary Motor Cortex
- Keywords
- Primary motor cortex, dorsolateral prefrontal cortex, physical endurance, tDCS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Collaborators
- University of A Coruna, La Coruna, Spain
- Study start
- 6 Jan 2024 (actual)
- Primary completion
- 8 Mar 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 25 Jun 2024 (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.
Introduction and Background:
Transcranial direct current stimulation (tDCS) has emerged as a potential intervention to improve physical performance. The primary aim of this study is to investigate the effects of tDCS applied to the primary motor cortex (M1) and dorsolateral prefrontal cortex (DLPFC) on performance in a maximal effort task, specifically the No Jump Burpee exercise.
Study Design:
This study will utilize a double-blind crossover design, where each subject will complete three experimental conditions: a-DLPFC, a-M1, and SHAM.
Participants:
Twenty healthy male subjects will be recruited for the study.
Intervention:
Each participant will undergo three conditions in a randomized order:
a-DLPFC: tDCS applied to the dorsolateral prefrontal cortex.
a-M1: tDCS applied to the primary motor cortex. SHAM: Placebo stimulation.
Procedure:
Prior to performing the No Jump Burpee exercise to exhaustion, tDCS will be administered at a current of 2 milliampere (mA) for 20 minutes.
Measurements:
The following variables will be measured during the exercise:
Total number of repetitions of the No Jump Burpee exercise. Vastus lateralis muscle oxygen saturation. Heart rate. Subjective perception of exertion (RPE).
Data Analysis:
Repeated measures ANOVAs will be used to analyze the effects of the different tDCS conditions on the performance outcomes.
Ethical Considerations:
The study protocol will be reviewed and approved by an appropriate ethics committee. Written informed consent will be obtained from all participants before participation in the study.
Objectives:
The primary objective is to evaluate the impact of tDCS on physical performance, specifically measuring the total number of repetitions of the No Jump Burpee exercise. Secondary objectives include assessing the changes in muscle oxygen saturation, heart rate, and subjective perception of exertion.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- The study applied a double-blind, crossover design to examine the viability of tDCS in improving performance during a maximal effort task, particularly the "No Jump Burpee" exercise.
| Arm | Type | Receives |
|---|---|---|
| tDCS Targeting the Dorsolateral Prefrontal Cortex (DLPFC) | Experimental | Device: tDCS targeting DLPFCParticipants in this arm will receive transcranial Direct Current Stimulation (tDCS) targeting the DLPFC. The tDCS will be administered at an intensity of 2 mA for 20 minutes. This arm aims to evaluate the effects of DLPFC stimulation on performance during a maximal effort "No Jump Burpee" exercise. |
| tDCS Targeting the Primary Motor Cortex (M1) | Experimental | Device: tDCS targeting M1Participants in this arm will receive transcranial Direct Current Stimulation (tDCS) targeting the primary motor cortex (M1). The tDCS will be administered at an intensity of 2 mA for 20 minutes. This arm aims to evaluate the effects of M1 stimulation on performance during a maximal effort "No Jump Burpee" exercise. |
| SHAM tDCS | Sham comparator | Device: SHAM tDCSParticipants in this arm will receive a sham tDCS session, which simulates the experience of tDCS without actual stimulation. This arm serves as a control to ensure the blinding of participants and evaluators. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subject.
- No use of any ergogenic substance.
- Participants must be recreationally active, defined as engaging in moderate physical activity at least 3 times per week for the past 6 months
Key exclusion criteria (5 listed)
- Any contraindications to transcranial Direct Current Stimulation, such as metallic implants in the head, active implanted medical devices (e.g., pacemakers), or skin conditions affecting the scalp.
- Current or recent (within the past 6 months) substance abuse, including alcohol or recreational drugs.
- Musculoskeletal injury within the past 6 weeks.
- Lower extremity pain above 3 or more according to numeric pain scale.
- History of epilepsy or convulsive crisis.
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 |
|---|---|---|
| tDCS targeting DLPFCThe anodic electrode will be placed on the left DLPFC (area F3) and the cathode on the right orbitofrontal cortex (area Fp2). Participants will receive 20 minutes of tDCS at 2 mA while seated. | Device | tDCS Targeting the Dorsolateral Prefrontal Cortex (DLPFC) |
| tDCS targeting M1The anodes will be placed over C3 and C4 (according to EEG 10-20 system), and the cathodes over the ipsilateral shoulders. Participants will receive 20 minutes of tDCS at 2 mA while seated. | Device | tDCS Targeting the Primary Motor Cortex (M1) |
| SHAM tDCSThe electrodes will be placed as in the other conditions, but the stimulation will be switched off after 30 seconds, providing an initial stinging sensation without continuous stimulation. | Device | SHAM tDCS |
Primary outcome
Number of "No Jump Burpees" to Exhaustion
Time frame: Measured immediately at the end of each experimental session (DLPFC, M1, SHAM), approximately 5-10 minutes after the start of the test..
The primary objective of the study is to measure the number of repetitions of the "No Jump Burpee" exercise that participants can perform until exhaustion. This exercise is performed at a cadence of 20 burpees per minute, and exhaustion is determined when the participant can no longer maintain the correct pace or technique.
3 secondary outcomes
Rating of Perceived Exertion (RPE)
Time frame: Measured every 20 seconds during exercise, from the start until the participant reaches exhaustion, approximately 5-15 minutes per session.
Muscle Oxygen Saturation in the Vastus Lateralis
Time frame: Measured continuously at a frequency of 1 Hz during the exercise, from the start until the participant reaches exhaustion, approximately 5-15 minutes per session.
Heart Rate During Exercise
Time frame: Measured continuously on a beat-by-beat basis during the exercise, from the start until the participant reaches exhaustion, approximately 5-15 minutes per session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS targeting DLPFC and tDCS targeting M1 in people with Transcranial Direct Current Stimulation and Dorsolateral Prefrontal Cortex, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of "No Jump Burpees" to Exhaustion (time frame: Measured immediately at the end of each experimental session (DLPFC, M1, SHAM), approximately 5-10 minutes after the start of the test..). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2024.