Healthy VolunteersPhase 2/3NCT03870139
Cerebral and Peripheral Electrical Stimulation on Isometric Quadriceps Strength
A Phase 2/3 study testing Cerebral stimulation and Peripheral stimulation in people with Healthy Volunteers, run by Universidade Federal do Piauí at 1 site in Brazil.
Trial summary
Quadriceps muscle strength is a key goal to be achieved in rehabilitation protocols for a variety of musculoskeletal conditions. Both cerebral and peripheral electrical stimulations can modulate motor brain areas involved in motor functions and has the potential to optimize muscle capacity. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Cerebral stimulation and Peripheral stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Mar 2019to 7 May 2019
- 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
- All sexes
- 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 Peripheral and Cerebral Electrical Stimulation on Maximal Isometric Strength of Knee Extensors
Quadriceps muscle strength is a key goal to be achieved in rehabilitation protocols for a variety of musculoskeletal conditions. Both cerebral and peripheral electrical stimulations can modulate motor brain areas involved in motor functions and has the potential to optimize muscle capacity. However, their effects on quadriceps function are lacking.
This study aims to investigate the effects of transcranial direct current stimulation (tDCS) and peripheral electrical stimulation (PES) on quadriceps strength in healthy subjects.
- Conditions
- Healthy Volunteers
- Being tested
- Cerebral stimulation, Peripheral stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral stimulationDevice
Also called Transcranial direct current stimulation
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.
Peripheral stimulationDevice
Peripheral electrical stimulation (PES) activates a complex neural network involving a series of neurotransmitters and receptors capable of promoting segmental and extrasegmental analgesia. Moreover, recent evidence has shown that PES can activate brain motor areas such as primary motor cortex.
| Study group | Role | What they receive |
|---|---|---|
| Cerebral stimulation | Active comparator | Active transcranial direct current stimulation
tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the dominant lower limb) and supraorbital cathode (ipsilateral to the dominant lower limb). Receives: Device: Cerebral stimulation |
| Combined stimulation 1 | Experimental | Active peripheral electrical stimulation (PES_sensorial) combined with active transcranial direct current stimulation
tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).
PES_sensorial: 20 minutes, 10Hz (frequency), 100µs (pulse duration), intensity at sensorial level. Receives: Device: Cerebral stimulation; Device: Peripheral stimulation |
| Peripheral stimulation | Active comparator | Active peripheral electrical stimulation (PES_motor).
PES: 15 minutes, 30Hz (frequency), 100µs (pulse duration), intensity at motor level. Receives: Device: Peripheral stimulation |
| Combined stimulation 2 | Experimental | Active sensorial peripheral electrical stimulation (PES_sensorial) combined with active motor peripheral electrical stimulation (PES_motor)
PES_sensorial: 20 minutes, 10Hz (frequency), 100µs (pulse duration), intensity at sensorial level
PES_motor: 15 minutes, 30Hz (frequency), 100µs (pulse duration), intensity at motor level. Receives: Device: Cerebral stimulation; Device: Peripheral stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric quadriceps strength
Maximal isometric voluntary contraction (Kgf)
Measured: Pre and Post-test (immediately after tDCS)
Secondary outcomes (2)
Isometric quadriceps strength
Maximal isometric voluntary contraction (Kgf)
Measured: During stimulation
Isometric quadriceps strength
Maximal isometric voluntary contraction (Kgf)
Measured: 10 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 start30 Mar 2019
- Primary completion30 Apr 2019
- Study completion7 May 2019
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
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870139
- Sponsor's protocol ID
- tDCS and knee strength
- Status last verified
- May 2019
- First submitted
- 8 Mar 2019
- Last updated
- 9 May 2019
- Results posted
- 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 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Peripheral and Cerebral Electrical Stimulation on Maximal Isometric Strength of Knee Extensors
- ClinicalTrials.gov ID
- NCT03870139
- Acronym / sponsor ID
- tDCS and knee strength
- Conditions
- Healthy Volunteers
- 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
- 30 Mar 2019 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 7 May 2019 (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.
Quadriceps muscle strength is a key goal to be achieved in rehabilitation protocols for a variety of musculoskeletal conditions. Both cerebral and peripheral electrical stimulations can modulate motor brain areas involved in motor functions and has the potential to optimize muscle capacity. However, their effects on quadriceps function are lacking.
This study aims to investigate the effects of transcranial direct current stimulation (tDCS) and peripheral electrical stimulation (PES) on quadriceps strength in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cerebral stimulation | Active comparator | Device: Cerebral stimulationActive transcranial direct current stimulation tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the dominant lower limb) and supraorbital cathode (ipsilateral to the dominant lower limb). |
| Combined stimulation 1 | Experimental | Device: Cerebral stimulation, Device: Peripheral stimulationActive peripheral electrical stimulation (PES_sensorial) combined with active transcranial direct current stimulation tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion). PES_sensorial: 20 minutes, 10Hz (frequency), 100µs (pulse duration), intensity at sensorial level. |
| Peripheral stimulation | Active comparator | Device: Peripheral stimulationActive peripheral electrical stimulation (PES_motor). PES: 15 minutes, 30Hz (frequency), 100µs (pulse duration), intensity at motor level. |
| Combined stimulation 2 | Experimental | Device: Cerebral stimulation, Device: Peripheral stimulationActive sensorial peripheral electrical stimulation (PES_sensorial) combined with active motor peripheral electrical stimulation (PES_motor) PES_sensorial: 20 minutes, 10Hz (frequency), 100µs (pulse duration), intensity at sensorial level PES_motor: 15 minutes, 30Hz (frequency), 100µs (pulse duration), intensity at motor level. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- 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 |
|---|---|---|
| Cerebral stimulationAlso: 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 | Cerebral stimulation, Combined stimulation 1, Combined stimulation 2 |
| Peripheral stimulationPeripheral electrical stimulation (PES) activates a complex neural network involving a series of neurotransmitters and receptors capable of promoting segmental and extrasegmental analgesia. Moreover, recent evidence has shown that PES can activate brain motor areas such as primary motor cortex. | Device | Combined stimulation 1, Combined stimulation 2, Peripheral stimulation |
Primary outcome
Isometric quadriceps strength
Time frame: Pre and Post-test (immediately after tDCS)
Maximal isometric voluntary contraction (Kgf)
2 secondary outcomes
Isometric quadriceps strength
Time frame: During stimulation
Isometric quadriceps strength
Time frame: 10 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 9 May 2019.
- 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 Phase 2/3 study testing Cerebral stimulation and Peripheral 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 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 9 May 2019. 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. 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 quadriceps strength (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 9 May 2019.