Asymptomatic ConditionNCT05210231
Effects of Transcranial Direct Current Stimulation (tDCS) on Rotator Cuff Fatigue.
A study testing Transcranial Direct Current Stimulation in people with Asymptomatic Condition, run by University of Gran Rosario at 1 site in Argentina.
Trial summary
The aim of this study will be to determine the effects of active tDCS on rotator cuff fatigue. This study will be a randomized, double-blind, sham-controlled, cross-over clinical trial based on non-probabilistic sampling for convenience, comprising a sample of 20 active asymptomatic subjects of all genders and aged… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Asymptomatic Condition
- What is being tested?
- Transcranial Direct Current Stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteArgentina
- Study dates
- 7 Mar 2022to 5 May 2023
- Phase
- Interventional
- 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
- Age ranging between 18 to 35 years, all genders.
- Healthy subjects
- Moderate physical activity (evaluated by IPAQ questionnaire)
- Do not perform any exhausting exercise and do not drink alcoholic or caffeinated beverages during the time the work is performed.
Who cannot join
- Subjects with trauma in the last three weeks or previous surgeries on the upper extremity, patients with pre-existing neurological or rheumatic conditions, pregnancy, medical history of epilepsy the convulsive event, subjects under analgesic drug treatment or have ingested drugs with central action in the last 72 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Transcranial Direct Current Stimulation (tDCS) on Rotator Cuff Fatigue. A Randomized, Sham-controlled, Double-blind, Crossover Study.
The aim of this study will be to determine the effects of active tDCS on rotator cuff fatigue. This study will be a randomized, double-blind, sham-controlled, cross-over clinical trial based on non-probabilistic sampling for convenience, comprising a sample of 20 active asymptomatic subjects of all genders and aged between 18 and 35 years old. Subjects will be recruited via social networks, WhatsApp and emails and must be currently engaged in moderate physical activity (assessed by the IPAQ questionnaire) and asymptomatic at the time of assessment. In addition, participants will be asked not to perform any type of strenuous exercise and do not drink alcoholic or caffeinated beverages during the time the work is performed. The study will consist of three sessions, with an interval of 72 hours between them.
- Conditions
- Asymptomatic Condition
- Being tested
- Transcranial Direct Current Stimulation
- Keywords
- Brain stimulation, tDCS, Fatigue, Rotator cuff
- Medical subject headings
- Asymptomatic Diseases, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationOther
The direct electric current will be applied through a pair of sponges humidified with saline solution (150 mMols of NaCl diluted in water Milli-Q) on the electrodes (35 cm2). The electrodes (anode and cathode) will be connected to a continuous electric stimulator (Model: Microestim Foco Research, Brand: NKL, Souza Cruz, Brusque - SC, Brazil), with one energy battery (9 V) and will be mounted in accordance with the International 10-20 EEG System. For anodal polarity stimulation over the left TC, the anodal electrode will be placed over the scalp on the T3 area located at 40% of the distance on the left from the Cz point. The cathode electrode will be placed over the contralateral supraorbital area (Fp2). Thereafter, a constant electric current of 2 mA will be applied for 20 min.
| Study group | Role | What they receive |
|---|---|---|
| Active anodal tDCS | Experimental | The direct electric current will be applied through a pair of sponges humidified with saline solution (150 mMols of NaCl diluted in water Milli-Q) on the electrodes (35 cm2). The electrodes (anode and cathode) will be connected to a continuous electric stimulator (Model: Microestim Foco Research, Brand: NKL, Souza Cruz, Brusque - SC, Brazil), with one energy battery (9 V) and will be mounted in accordance with the International 10-20 EEG System. For anodal polarity stimulation over the left TC, the anodal electrode will be placed over the scalp on the T3 area located at 40% of the distance on the left from the Cz point. The cathode electrode will be placed over the contralateral supraorbital area (Fp2). Thereafter, a constant electric current of 2 mA will be applied for 20 min. Receives: Other: Transcranial Direct Current Stimulation |
| Sham anodal tDCS | Sham comparator | The direct electric current will apply through a pair of sponges humidified with saline solution (150 mMols of NaCl diluted in water Milli-Q) on the electrodes (35 cm2). The electrodes (anode and cathode) will be connected to a continuous electric stimulator (Model: Microestim Foco Research, Brand: NKL, Souza Cruz, Brusque - SC, Brazil), with one energy battery (9 V) and will be mounted in accordance with the International 10-20 EEG System. For the sham condition, the electrodes will be placed at the same positions as for the anodal tDCS. However, the stimulator will turn off after 30 s of stimulation. As a result, subjects will report the same sensory feelings from the beginning of the real tDCS conditions, specifically itching and tingling feelings on the scalp for the first few seconds of tDCS, but not thereafter, whether or not the stimulation will continue or stop. Receives: Other: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Time to Exhaustion (TTE)
To assess endurance performance, participants will perform a submaximal isometric time to exhaustion (TTE) task of the shoulder external rotator muscles at 50% of their maximal voluntary contraction (MVC), which will be performed during each visit. During the TTE each participant will receive visual feedback on a computer monitor showing the target force. The task will finish when their force is below the required target value for more than 3 s. None of the participants will be aware of the time elapsed during the test and results of all the sessions will be provided only after the completion of all visits. Participants' perception of effort will be measured using the RPE scale (Borg, 1998) every 20 s of the TTE task. Leg muscle pain will be assessed every 20 s by using the Numerical Pain Rating Scale (NPRS).
Measured: At baseline, after 3 and 6 days
Change in Maximum Voluntary Contraction (MVC)
After a brief standardized warm-up with submaximal isometric contractions, all participants will perform a 6 seconds MVC of infraspinatus muscle. For the MVC, subjects will be standing, with the shoulder in adduction position and the elbow flexed at 90°. The record will be evaluated by a load cell S200 (Miotec™, Porto Alegre, Brazil). The MVC produced during this test will be used to calculate the participants' 50% MVC used in the subsequent TTE task of that visit.
Measured: At baseline, after 3 and 6 days
Change in Rating of Perceived Exertion (RPE)
Borg rating of perceived exertion (RPE) is an outcome measure scale used in knowing exercise intensity prescription. The RPE will be evaluated using the BORG CR10 scale, its ranges are from "0" (no exertion) to "10" (maximum effort). The RPE will be evaluated using the BORG CR10 scale, its ranges are from "0" (no effort) to "10" (maximum effort). The perception of the effort of the participants will be measured every 20 s during the TTE task.
Measured: At baseline, after 3 and 6 days
Secondary outcomes (2)
Change in Global Rating of Change Scale (GRCS)
For the Global Rating of Change Scale, in the second and third visit, subjects will be asked about their perception of change in relation to the endurance task relative to their status at the first visit.
Measured: After 3 and 6 days
Change in Electromyographic recordings (sEMG)
Surface electromyography (sEMG) assessment will be performed on the infraspinatus and deltoid muscles, using an acquisition module with four analog channels (Miotec™, Biomedical Equipments, Porto Alegre, Brazil). The conversion from analog to digital signals will be performed by an A/D board with 16-bit resolution input range, sampling frequency of 2 kHz, common rejection module greater than 100 dB, signal-noise ratio less than 03 μV Root Mean Square and impedance of 109 Ω. The sEMG signals will be recorded through surface Ag/AgCl electrodes (Meditrace™, Canada) with a centre-to-centre distance of 2 centimeters, in a parallel orientation to the underlying muscle fibers. A ground electrode will be placed in the lateral epicondyle of the contralateral arm The skin will be shaved and cleaned using alcohol swabs, following standardized guidelines. A fatigue study will be carried out using a frequency analysis.
Measured: At baseline, after 3 and 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start7 Mar 2022
- Primary completion23 Apr 2023
- Study completion5 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic ConditionStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gran Rosario
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Barone, University of Gran Rosario
- Investigators
- Cristian Mendoza, MsC, Principal investigator, University of Gran Rosario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210231
- Sponsor's protocol ID
- tDCS and Rotator Cuff
- Status last verified
- Mar 2023
- First submitted
- 25 Jan 2022
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation (tDCS) on Rotator Cuff Fatigue. A Randomized, Sham-controlled, Double-blind, Crossover Study.
- ClinicalTrials.gov ID
- NCT05210231
- Acronym / sponsor ID
- tDCS and Rotator Cuff
- Conditions
- Asymptomatic Condition
- Keywords
- Brain stimulation, tDCS, Fatigue, Rotator cuff
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Gran RosarioUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 23 Apr 2023 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 27 Jan 2022 (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.
The aim of this study will be to determine the effects of active tDCS on rotator cuff fatigue. This study will be a randomized, double-blind, sham-controlled, cross-over clinical trial based on non-probabilistic sampling for convenience, comprising a sample of 20 active asymptomatic subjects of all genders and aged between 18 and 35 years old. Subjects will be recruited via social networks, WhatsApp and emails and must be currently engaged in moderate physical activity (assessed by the IPAQ questionnaire) and asymptomatic at the time of assessment. In addition, participants will be asked not to perform any type of strenuous exercise and do not drink alcoholic or caffeinated beverages during the time the work is performed. The study will consist of three sessions, with an interval of 72 hours between them.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active anodal tDCS | Experimental | Other: Transcranial Direct Current StimulationThe direct electric current will be applied through a pair of sponges humidified with saline solution (150 mMols of NaCl diluted in water Milli-Q) on the electrodes (35 cm2). The electrodes (anode and cathode) will be connected to a continuous electric stimulator (Model: Microestim Foco Research, Brand: NKL, Souza Cruz, Brusque - SC, Brazil), with one energy battery (9 V) and will be mounted in accordance with the International 10-20 EEG System. For anodal polarity stimulation over the left TC, the anodal electrode will be placed over the scalp on the T3 area located at 40% of the distance on the left from the Cz point. The cathode electrode will be placed over the contralateral supraorbital area (Fp2). Thereafter, a constant electric current of 2 mA will be applied for 20 min. |
| Sham anodal tDCS | Sham comparator | Other: Transcranial Direct Current StimulationThe direct electric current will apply through a pair of sponges humidified with saline solution (150 mMols of NaCl diluted in water Milli-Q) on the electrodes (35 cm2). The electrodes (anode and cathode) will be connected to a continuous electric stimulator (Model: Microestim Foco Research, Brand: NKL, Souza Cruz, Brusque - SC, Brazil), with one energy battery (9 V) and will be mounted in accordance with the International 10-20 EEG System. For the sham condition, the electrodes will be placed at the same positions as for the anodal tDCS. However, the stimulator will turn off after 30 s of stimulation. As a result, subjects will report the same sensory feelings from the beginning of the real tDCS conditions, specifically itching and tingling feelings on the scalp for the first few seconds of tDCS, but not thereafter, whether or not the stimulation will continue or stop. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age ranging between 18 to 35 years, all genders.
- Healthy subjects
- Moderate physical activity (evaluated by IPAQ questionnaire)
- Do not perform any exhausting exercise and do not drink alcoholic or caffeinated beverages during the time the work is performed.
Key exclusion criteria (1 listed)
- Subjects with trauma in the last three weeks or previous surgeries on the upper extremity, patients with pre-existing neurological or rheumatic conditions, pregnancy, medical history of epilepsy the convulsive event, subjects under analgesic drug treatment or have ingested drugs with central action in the last 72 hours.
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 StimulationThe direct electric current will be applied through a pair of sponges humidified with saline solution (150 mMols of NaCl diluted in water Milli-Q) on the electrodes (35 cm2). The electrodes (anode and cathode) will be connected to a continuous electric stimulator (Model: Microestim Foco Research, Brand: NKL, Souza Cruz, Brusque - SC, Brazil), with one energy battery (9 V) and will be mounted in accordance with the International 10-20 EEG System. For anodal polarity stimulation over the left TC, the anodal electrode will be placed over the scalp on the T3 area located at 40% of the distance on the left from the Cz point. The cathode electrode will be placed over the contralateral supraorbital area (Fp2). Thereafter, a constant electric current of 2 mA will be applied for 20 min. | Other | Active anodal tDCS, Sham anodal tDCS |
Primary outcome
Change in Time to Exhaustion (TTE)
Time frame: At baseline, after 3 and 6 days
To assess endurance performance, participants will perform a submaximal isometric time to exhaustion (TTE) task of the shoulder external rotator muscles at 50% of their maximal voluntary contraction (MVC), which will be performed during each visit. During the TTE each participant will receive visual feedback on a computer monitor showing the target force. The task will finish when their force is below the required target value for more than 3 s. None of the participants will be aware of the time elapsed during the test and results of all the sessions will be provided only after the completion of all visits. Participants' perception of effort will be measured using the RPE scale (Borg, 1998) every 20 s of the TTE task. Leg muscle pain will be assessed every 20 s by using the Numerical Pain Rating Scale (NPRS).
Change in Maximum Voluntary Contraction (MVC)
Time frame: At baseline, after 3 and 6 days
After a brief standardized warm-up with submaximal isometric contractions, all participants will perform a 6 seconds MVC of infraspinatus muscle. For the MVC, subjects will be standing, with the shoulder in adduction position and the elbow flexed at 90°. The record will be evaluated by a load cell S200 (Miotec™, Porto Alegre, Brazil). The MVC produced during this test will be used to calculate the participants' 50% MVC used in the subsequent TTE task of that visit.
Change in Rating of Perceived Exertion (RPE)
Time frame: At baseline, after 3 and 6 days
Borg rating of perceived exertion (RPE) is an outcome measure scale used in knowing exercise intensity prescription. The RPE will be evaluated using the BORG CR10 scale, its ranges are from "0" (no exertion) to "10" (maximum effort). The RPE will be evaluated using the BORG CR10 scale, its ranges are from "0" (no effort) to "10" (maximum effort). The perception of the effort of the participants will be measured every 20 s during the TTE task.
2 secondary outcomes
Change in Global Rating of Change Scale (GRCS)
Time frame: After 3 and 6 days
Change in Electromyographic recordings (sEMG)
Time frame: At baseline, after 3 and 6 days
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 11 May 2023.
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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.
Cristian Mendoza, MsC principal investigator
University of Gran Rosario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation in people with Asymptomatic Condition, run by University of Gran Rosario at 1 site in Argentina.
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 4 inclusion and 1 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 11 May 2023. 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 Argentina. 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.
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?
Change in Time to Exhaustion (TTE) (time frame: At baseline, after 3 and 6 days). The study lists 3 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 11 May 2023.