NCT04005846

Brief Summary

Many different factors affect running performance, transcranial direct current stimulation (tDCS) is a widely used and available neuromodulation tool and could hypothetically facilitate the supraspinal drive and thereby act upstream of the motor cortex to prolong the muscles work in time to exhaustion trials. While it appears to decrease the rating of perceived exertion (RPE) during cycling, little is known about the effects of tDCS on physiological performance parameters such as maximal oxygen consumption (VO2max), maximal aerobic speed (MAS) and lactate thresholds in runners. The aim of this prospective randomized sham-controlled clinical trial is to investigate the physiological effects of tDCS applied over the motor cortex on perceived exertion and performance-related parameters measured by an incremental treadmill test to exhaustion. This research thus aims at answering the following questions:

  1. 1.Is active tDCS applied bilaterally over the motor cortex significantly more efficient than sham tDCS to improve the TTE?
  2. 2.Does active tDCS decreases the RPE, as compared to sham?
  3. 3.Is there any significant difference between active and sham tDCS on the physiological parameters measured during an incremental test to exhaustion, namely: VO2max, MAS, respiratory exchange ratio, blood lactate levels, maximal heart rate?
  4. 4.Does the baseline level of physical fitness influences response to tDCS?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2019

Typical duration for phase_1

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

3.6 years

First QC Date

June 21, 2019

Last Update Submit

May 8, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to exertion (active vs. sham)

    Time to achieve exhaustion during a treadmill test where the speed is set at a constant 90% of the individual maximal aerobic speed (determined during the screening visit)

    Immediate

Secondary Outcomes (3)

  • Ratings of perceived exertion (RPE) evolution (active vs. sham)

    Every 3 minutes during the test to exhaustion until the end of the test (up to 1 hour after the stimulation)

  • Maximal Oxygen Consumption (VO2max) evolution (active vs. sham)

    Immediate

  • Lactate thresholds (active vs. sham)

    Every 3 minutes during the test to exhaustion until the end of the test (up to 1 hour after the stimulation)

Study Arms (2)

Active tDCS first / Sham tDCS second

OTHER

Receiving active tDCS during the first visit followed by sham tDCS on the next visit

Device: Transcranial Direct Current Stimulation (tDCS)

Sham tDCS first / Active tDCS second

OTHER

Receiving sham tDCS during the first visit followed by active tDCS on the next visit

Device: Transcranial Direct Current Stimulation (tDCS)

Interventions

The active session of tDCS will consist in applying two anodes over M1 bilaterally (C3 and C4 according to the 10-20 international EEG placement) and the cathodes over the occipital areas (O1 and O2), and to inject 2 mA for 20 minutes through sponge electrodes (35 cm²) placed on the scalp using the Startsim 8 (Neuroelectrics, Barcelona). The sham tDCS will use the same montage and device but direct current will only be injected for 30 seconds, with a ramp-up and ramp-down 15 seconds period, to mimic the somatosensory effects of active tDCS.

Active tDCS first / Sham tDCS secondSham tDCS first / Active tDCS second

Eligibility Criteria

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

You may qualify if:

  • Healthy subject
  • Regular running activity above 2 hours/week
  • VO2max above 30 mL/min/kg

You may not qualify if:

  • Pacemaker
  • Intracerebral metallic implant
  • Smoking
  • Using dietary supplementation or medication potentially affecting the CNS
  • Musculoskeletal injury within the past 6 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ISEPK ULiège

Liège, 4000, Belgium

Location

Related Publications (1)

  • Martens G, Hody S, Bornheim S, Angius L, De Beaumont L, Fregni F, Ruffini G, Kaux JF, Thibaut A, Bury T. Can transcranial direct current stimulation (tDCS) over the motor cortex increase endurance running performance? a randomized crossover-controlled trial. PLoS One. 2024 Dec 5;19(12):e0312084. doi: 10.1371/journal.pone.0312084. eCollection 2024.

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Double-blind randomized sham controlled crossover
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 21, 2019

First Posted

July 2, 2019

Study Start

September 1, 2019

Primary Completion

April 15, 2023

Study Completion

April 15, 2023

Last Updated

May 9, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations