Healthy VolunteersPhase 2/3NCT04467476
Effects of tDCS on Anaerobic Power of Lower Limb Muscles
A Phase 2/3 study testing Transcranial direct current stimulation in people with Healthy Volunteers, run by Universidade Federal do Piauí at 1 site in Brazil.
Trial summary
Anaerobic power and capacity are essential in many human activities, especially during sports practice that demand a high strength and power of the limbs. Transcranial direct current stimulation is a noninvasive technique that can modulate motor brain areas involved in motor functions and has the potential to optimize… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2021to 29 Apr 2021
- Phase
- Phase 2/3
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects with no complaints of pain or any kind of discomfort in the musculoskeletal system
Who cannot join
- Musculoskeletal or neurological disorder
- Under medication
- Previous treatment with tDCS
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Physical Therapy. Federal University of Piaui
Parnaíba, Piauí, 64202020
About this study
Official title: Effects of tDCS on Mechanical Power of the Leg Extensor Muscles of Healthy Subjects
Anaerobic power and capacity are essential in many human activities, especially during sports practice that demand a high strength and power of the limbs. Transcranial direct current stimulation is a noninvasive technique that can modulate motor brain areas involved in motor functions and has the potential to optimize muscle capacity. However, their effects on mechanical power are lacking.
This study aims to investigate the effects of transcranial direct current stimulation (tDCS) on mechanical power in healthy subjects.
Read the detailed description
In this study, a randomized, crossover, double-blind, placebo-controlled experimental design will be used. The 50 participants will be randomized into two groups: (1) Anodal tDCS(real) and (2) Sham tDCS. A single session of anodal and sham tDCS will be performed on each task (pre and post-jump test).
All evaluations will be performed by a single researcher who, like the participants, will not know which stimulation group will be participating. Subjects who agree to the conditions and sign the consent form may participate in the study. Participants who meet the eligibility criteria will be included in the study.
- Conditions
- Healthy Volunteers
- Being tested
- Transcranial direct current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation (NIBS) technique that has been investigated for the management of various health conditions. However, its ergogenic effect still has controversial results.
| Study group | Role | What they receive |
|---|---|---|
| tDCS (anodal) | Active comparator | tDCS: 20 minutes, 2mA, over the motor cortex representation of lower limbs. Receives: Device: Transcranial direct current stimulation |
| tDCS (sham) | Sham comparator | tDCS: 20 minutes (but 30s ON), 2mA, over the motor cortex representation of lower limbs. Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean anaerobic power
Mean anaerobic power will be evaluated by assessing the ground reaction forces (GRF) and the number of jumps in each test by means of the kinetic analysis of the 60-second vertical jump test (Bosco's Test).
Measured: Pre and Post-test (immediately after tDCS)
Secondary outcomes (3)
Peak anaerobic power
Peak anaerobic power will be evaluated by assessing the ground reaction forces (GRF) and the number of jumps in each test by means of the kinetic analysis of the 60-second vertical jump test (Bosco's Test).
Measured: Pre and Post-test (immediately after tDCS)
Fatigue index
Fatigue index will be evaluated by assessing the ground reaction forces (GRF) and the number of jumps in each test by means of the kinetic analysis of the 60-second vertical jump test (Bosco's Test).
The fatigue index corresponds to the power reduction rate expressed as a percentage and reveals the degree of reduction in the ability to produce strength and maintain exercise.
Measured: Pre and Post-test (immediately after tDCS)
Rating of perceived exertion
The subjective feeling of effort will be assessed by the Borg scale for perceived effort. This is a 15-point numerical scale that ranges from 6 to 20, where 6 means "no exertion at all" and 20 means "maximal exertion."
Measured: Post-test (immediately after tDCS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start1 Jan 2021
- Primary completion28 Feb 2021
- Study completion29 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Piauí
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fuad Ahmad Hazime, Universidade Federal do Piauí
- Investigators
- Fuas A Hazime, PhD, Principal investigator, Department of Physical Therapy. Federal University of Piaui
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467476
- Sponsor's protocol ID
- tDCS and anaerobic power
- Status last verified
- Apr 2021
- First submitted
- 7 Jul 2020
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of tDCS on Mechanical Power of the Leg Extensor Muscles of Healthy Subjects
- ClinicalTrials.gov ID
- NCT04467476
- Acronym / sponsor ID
- tDCS and anaerobic power
- Conditions
- Healthy Volunteers
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidade Federal do PiauíUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 29 Apr 2021 (actual)
- First posted
- 13 Jul 2020 (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.
Anaerobic power and capacity are essential in many human activities, especially during sports practice that demand a high strength and power of the limbs. Transcranial direct current stimulation is a noninvasive technique that can modulate motor brain areas involved in motor functions and has the potential to optimize muscle capacity. However, their effects on mechanical power are lacking.
This study aims to investigate the effects of transcranial direct current stimulation (tDCS) on mechanical power in healthy subjects.
Detailed description
In this study, a randomized, crossover, double-blind, placebo-controlled experimental design will be used. The 50 participants will be randomized into two groups: (1) Anodal tDCS(real) and (2) Sham tDCS. A single session of anodal and sham tDCS will be performed on each task (pre and post-jump test).
All evaluations will be performed by a single researcher who, like the participants, will not know which stimulation group will be participating. Subjects who agree to the conditions and sign the consent form may participate in the study. Participants who meet the eligibility criteria will be included in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS (anodal) | Active comparator | Device: Transcranial direct current stimulationtDCS: 20 minutes, 2mA, over the motor cortex representation of lower limbs. |
| tDCS (sham) | Sham comparator | Device: Transcranial direct current stimulationtDCS: 20 minutes (but 30s ON), 2mA, over the motor cortex representation of lower limbs. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects with no complaints of pain or any kind of discomfort in the musculoskeletal system
Key exclusion criteria (3 listed)
- Musculoskeletal or neurological disorder
- Under medication
- Previous treatment with tDCS
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 |
|---|---|---|
| Transcranial direct current stimulationTranscranial direct current stimulation (tDCS) is a noninvasive brain stimulation (NIBS) technique that has been investigated for the management of various health conditions. However, its ergogenic effect still has controversial results. | Device | tDCS (anodal), tDCS (sham) |
Primary outcome
Mean anaerobic power
Time frame: Pre and Post-test (immediately after tDCS)
Mean anaerobic power will be evaluated by assessing the ground reaction forces (GRF) and the number of jumps in each test by means of the kinetic analysis of the 60-second vertical jump test (Bosco's Test).
3 secondary outcomes
Peak anaerobic power
Time frame: Pre and Post-test (immediately after tDCS)
Fatigue index
Time frame: Pre and Post-test (immediately after tDCS)
Rating of perceived exertion
Time frame: Post-test (immediately after tDCS)
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 3 May 2021.
- Individual participant dataSharing planned: Undecided
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Screening Protocol
Pain
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.
Fuas A Hazime, PhD principal investigator
Department of Physical Therapy. Federal University of Piaui
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Transcranial direct current stimulation in people with Healthy Volunteers, run by Universidade Federal do Piauí at 1 site in Brazil.
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 1 inclusion and 3 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 3 May 2021. 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 Brazil. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean anaerobic power (time frame: Pre and Post-test (immediately after tDCS)). 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 3 May 2021.