HealthyPhase 2/3NCT03870178
Effects of tDCS on Maximal Isometric Strength and Endurance Test of Trunk Extensors.
A Phase 2/3 study testing Transcranial direct current stimulation (tDCS) in people with Healthy, run by Universidade Federal do Piauí at 1 site in Brazil.
Trial summary
Improving trunk muscle strength and endurance is one of the many goals to be achieved in rehabilitation protocols for a variety of health conditions. Cerebral electrical stimulations techniques, such as transcranial direct current stimulation (tDCS) can modulate motor brain areas involved in motor functions. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jan 2019to 30 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects with no complaints of pain, discomfort in the musculoskeletal system.
Who cannot join
- Musculoskeletal or neurological disorder
- Under medication
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 Maximal Isometric Strength and Endurance Test of Trunk Extensors in Healthy Subjects.
Improving trunk muscle strength and endurance is one of the many goals to be achieved in rehabilitation protocols for a variety of health conditions. Cerebral electrical stimulations techniques, such as transcranial direct current stimulation (tDCS) can modulate motor brain areas involved in motor functions. However, their effects on trunk function are lacking.
This study aims to investigate the effects of transcranial direct current stimulation (tDCS) on trunk muscle strength and endurance in healthy subjects.
- Conditions
- Healthy
- Being tested
- Transcranial direct current stimulation (tDCS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (tDCS)Device
The noninvasive and nonpharmacological weak electrical current applied to the scalp to modulate cortical excitability.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Active comparator | Anodal tDCS over trunk motor cortex representation. Intensity: 2mA Time: 20 minutes Receives: Device: Transcranial direct current stimulation (tDCS) |
| Sham tDCS | Sham comparator | Anodal tDCS over trunk motor cortex representation. Itensity: 2mA Time: 20 minutes (30s ON) Receives: Device: Transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric trunk extension
Maximal isometric voluntary contraction (Kgf)
Measured: Pre and Post-test (immediately after tDCS)
Trunk muscle endurance
Time to task failure (TTF) on the Sorensen test
Measured: Pre and Post-test (immediately after tDCS)
Secondary outcomes (4)
Isometric trunk extension
Maximal isometric voluntary contraction (Kgf)
Measured: 15 minutes post-stimulation
Isometric trunk extension
Maximal isometric voluntary contraction (Kgf)
Measured: 30 minutes post-stimulation
Trunk muscle endurance
Time to task failure (TTF) on the Sorensen test
Measured: 15 minutes post-stimulation
Trunk muscle endurance
Time to task failure (TTF) on the Sorensen test
Measured: 30 minutes post-stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start2 Jan 2019
- Primary completion30 Nov 2019
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 20 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
- Fuad Hazime, PhD, Principal investigator, Department of Physical Therapy. Federal University of Piaui
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870178
- Sponsor's protocol ID
- 1.577.037
- Status last verified
- Apr 2021
- First submitted
- 8 Mar 2019
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 Maximal Isometric Strength and Endurance Test of Trunk Extensors in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT03870178
- Acronym / sponsor ID
- 1.577.037
- Conditions
- Healthy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidade Federal do PiauíUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 11 Mar 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.
Improving trunk muscle strength and endurance is one of the many goals to be achieved in rehabilitation protocols for a variety of health conditions. Cerebral electrical stimulations techniques, such as transcranial direct current stimulation (tDCS) can modulate motor brain areas involved in motor functions. However, their effects on trunk function are lacking.
This study aims to investigate the effects of transcranial direct current stimulation (tDCS) on trunk muscle strength and endurance in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Active comparator | Device: Transcranial direct current stimulation (tDCS)Anodal tDCS over trunk motor cortex representation. Intensity: 2mA Time: 20 minutes |
| Sham tDCS | Sham comparator | Device: Transcranial direct current stimulation (tDCS)Anodal tDCS over trunk motor cortex representation. Itensity: 2mA Time: 20 minutes (30s ON) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects with no complaints of pain, discomfort in the musculoskeletal system.
Key exclusion criteria (2 listed)
- Musculoskeletal or neurological disorder
- Under medication
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 stimulation (tDCS)The noninvasive and nonpharmacological weak electrical current applied to the scalp to modulate cortical excitability. | Device | Active tDCS, Sham tDCS |
Primary outcome
Isometric trunk extension
Time frame: Pre and Post-test (immediately after tDCS)
Maximal isometric voluntary contraction (Kgf)
Trunk muscle endurance
Time frame: Pre and Post-test (immediately after tDCS)
Time to task failure (TTF) on the Sorensen test
4 secondary outcomes
Isometric trunk extension
Time frame: 15 minutes post-stimulation
Isometric trunk extension
Time frame: 30 minutes post-stimulation
Trunk muscle endurance
Time frame: 15 minutes post-stimulation
Trunk muscle endurance
Time frame: 30 minutes post-stimulation
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.
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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.
Fuad 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 (tDCS) in people with Healthy, 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 2 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?
Isometric trunk extension (time frame: Pre and Post-test (immediately after tDCS)). The study lists 2 primary outcomes in all. 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.