NCT06472882

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

June 13, 2024

Last Update Submit

June 18, 2024

Conditions

Keywords

Primary motor cortexdorsolateral prefrontal cortexphysical endurancetDCS

Outcome Measures

Primary Outcomes (1)

  • 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 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)

    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

    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

    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.

Other Outcomes (3)

  • Mood State Before Exercise

    Before each experimental session.

  • Anxiety Level Before Exercise

    Before each experimental session

  • Sleep Quality on the Night Prior to Exercise

    Before each experimental session.

Study Arms (3)

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.

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.

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.

Device: SHAM tDCS

Interventions

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 the Dorsolateral Prefrontal Cortex (DLPFC)

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.

tDCS Targeting the Primary Motor Cortex (M1)
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.

SHAM tDCS

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of Murcia

Guadalupe, Murcia, 30107, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
To ensure a double-blind design, the researcher who administered the tDCS was not present during the physical measurements, and the evaluator responsible for the physical measurements was unaware of the type of tDCS received by the participant. In this way, participants and evaluators remained blinded to the treatment administered.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

June 13, 2024

First Posted

June 25, 2024

Study Start

January 6, 2024

Primary Completion

March 8, 2024

Study Completion

April 15, 2024

Last Updated

June 25, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations