HealthyNCT06109727
Acute Effect of tDCS in Young Individuals
A study testing cerebellar transcranial electrical stimulation in people with Healthy, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
The aim of this study is to investigate the effect of transcranial electrical stimulation (tDCS) on motor performance, autonomic control and attentional and executive functions in young individuals. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- cerebellar transcranial electrical stimulation
- 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
- 1 Jan 2024to 31 Dec 2024
- 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-30 years
- participant of both sex
Who cannot join
- history of neurological or psychological diseases;
- use of any medications that may affect balance control, such as sedative drugs;
- presence of skeletal muscle injuries such as fracture, ligament injury, muscle tension or low back pain that restricts movement;
- presence of any sign of involvement of the spinal cord;
- visual or hearing impairment;
- musculoskeletal deformities in the lower or upper extremities that may affect the participant's standing posture;
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- skin conditions (e.g., eczema and injuries) on the scalp
- presence of metal inside the head (outside the mouth) such as splinters, surgical clips or fragments of solder or metal work;
- implanted devices such as cardiac pacemaker, cochlear implant;
- score less than 24 points in the Mini Mental State Examination (MMSE)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Tais Malysz
Porto Alegre, Rio Grande do Sul, 90630150
Taís Malysz, +5551995890622, tais.malysz@ufrgs.br
About this study
Official title: Acute Effect of tDCS on Motor Performance, Autonomic Control and Attentional and Executive Functions in Young Individuals
The aim of this study is to investigate the effect of transcranial electrical stimulation (tDCS) on motor performance, autonomic control and attentional and executive functions in young individuals.
Read the detailed description
Gait research in young and healthy individuals increases knowledge about the neuromuscular structures involved in this motor act and thus helps to develop or adapt therapeutic approaches that increase performance and/ or optimize the rehabilitation process for people with changes in gait control, and patients with neurological diseases. The aim of this study is to investigate the effect of transcranial electrical stimulation (tDCS) on motor performance, autonomic control and attentional and executive functions in young individuals. A total of 20 individuals (10 women and 10 men) aged 20-30 years will participate in this study. Each participant will visit the laboratory on three occasions, interspersed for one week, one visit for the initial evaluation (approximately 1 hour) and two visits for data collection, lasting approximately 1 hour and 40 minutes each. All participants will be randomly allocated in a double-blind and counterbalanced manner in the different experimental conditions. In one of the visits will be composing the intervention group (n=10; 20 min) and in another visit the Sham group (n=10). Outcomes related to motor performance (bilateral coordination, static and dynamic balance and functional mobility), heart rate variability and attentional and executive functions will be evaluated. To this end, the gait will be analyzed through the OpenCap motion analysis system from filming and after, the phase coordination index will be calculated for analysis of bilateral coordination; the stabilometry test will be used to assess the static balance of the participants, using a force platform where the participant remains standing on the platform to measure the center of pressure; functional mobility will be investigated from the 30-second sit-up test, aiming to analyze the dynamic balance and functional strength of the lower body, and the Timed up and Go Test used for balance analysis, gait and functional capacity. Heart rate variability will be recorded from the use of the Polar Vantage heart rate monitor (Finland), with the capacity of the R-R temporal record. The attentional and executive functions will be evaluated from the Stroop Test tool. These are three tasks with 24 items each, where the participant will be evaluated according to how quickly he performs the task and the amount of errors presented. The data will be described as mean. The normality of all data will be verified by the Shapiro-Wilk test. ANOVA with repeated measures of two factors will be used, followed by the Bonferroni post hoc test to compare the variables collected between the different conditions of brain stimulation (with and without application of tDCS) and between gait conditions. One-factor ANOVA will be used for brain stimulation conditions; data will be tabulated via Excel and statistical analyses will be performed in the SPSS software package for Windows version 24.0 (IBM, Chicago, USA). A significant value of p < 0.05 will be considered.
- Conditions
- Healthy
- Being tested
- cerebellar transcranial electrical stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cerebellar transcranial electrical stimulationDevice
Cerebellar transcranial electrical stimulation - 20 mA - 20 min
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | In the intervention group, the anodic stimulations will start after a ramp period of 30 s, followed by 20 min at 2 mili ampere and will end with a ramp of 30 s. Receives: Device: cerebellar transcranial electrical stimulation |
| Placebo | Placebo comparator | In the simulated configuration, the ramp of 30 s will be immediately followed by the ramp of 30 s and without any current (Sham Group) Receives: Device: cerebellar transcranial electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of tDCS on motor performance
- Bilateral coordination of different walking conditions will be assessed by percentage (%)
- The static equilibrium will be evaluated by the average amplitude of displacement of the center of pressure in mean lateral and anteroposterior directions (cm)
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
Effect of tDCS on functional mobility and dynamic balance
The 30-second sit and stand test - data expressed in number of repetitions The Time Up and Go Test (TUG) - data expressed in time(s)
Measured: Through study completion, an average of 1 year
Effect of variability of the heart rate
heart rate per min
Measured: Through study completion, an average of 1 year
Efect of tDCS on attentional and executive functions
time (s) to realize cognitives testes (Stroob test)
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 Jan 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taís Malysz, Federal University of Rio Grande do Sul
- Investigators
- Taís Malysz, Principal investigator, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109727
- Sponsor's protocol ID
- 71695023.3.0000.5347
- Status last verified
- Oct 2023
- First submitted
- 16 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- 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 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of tDCS on Motor Performance, Autonomic Control and Attentional and Executive Functions in Young Individuals
- ClinicalTrials.gov ID
- NCT06109727
- Acronym / sponsor ID
- 71695023.3.0000.5347
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 31 Oct 2023 (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 is to investigate the effect of transcranial electrical stimulation (tDCS) on motor performance, autonomic control and attentional and executive functions in young individuals.
Detailed description
Gait research in young and healthy individuals increases knowledge about the neuromuscular structures involved in this motor act and thus helps to develop or adapt therapeutic approaches that increase performance and/ or optimize the rehabilitation process for people with changes in gait control, and patients with neurological diseases. The aim of this study is to investigate the effect of transcranial electrical stimulation (tDCS) on motor performance, autonomic control and attentional and executive functions in young individuals. A total of 20 individuals (10 women and 10 men) aged 20-30 years will participate in this study. Each participant will visit the laboratory on three occasions, interspersed for one week, one visit for the initial evaluation (approximately 1 hour) and two visits for data collection, lasting approximately 1 hour and 40 minutes each. All participants will be randomly allocated in a double-blind and counterbalanced manner in the different experimental conditions. In one of the visits will be composing the intervention group (n=10; 20 min) and in another visit the Sham group (n=10). Outcomes related to motor performance (bilateral coordination, static and dynamic balance and functional mobility), heart rate variability and attentional and executive functions will be evaluated. To this end, the gait will be analyzed through the OpenCap motion analysis system from filming and after, the phase coordination index will be calculated for analysis of bilateral coordination; the stabilometry test will be used to assess the static balance of the participants, using a force platform where the participant remains standing on the platform to measure the center of pressure; functional mobility will be investigated from the 30-second sit-up test, aiming to analyze the dynamic balance and functional strength of the lower body, and the Timed up and Go Test used for balance analysis, gait and functional capacity. Heart rate variability will be recorded from the use of the Polar Vantage heart rate monitor (Finland), with the capacity of the R-R temporal record. The attentional and executive functions will be evaluated from the Stroop Test tool. These are three tasks with 24 items each, where the participant will be evaluated according to how quickly he performs the task and the amount of errors presented. The data will be described as mean. The normality of all data will be verified by the Shapiro-Wilk test. ANOVA with repeated measures of two factors will be used, followed by the Bonferroni post hoc test to compare the variables collected between the different conditions of brain stimulation (with and without application of tDCS) and between gait conditions. One-factor ANOVA will be used for brain stimulation conditions; data will be tabulated via Excel and statistical analyses will be performed in the SPSS software package for Windows version 24.0 (IBM, Chicago, USA). A significant value of p < 0.05 will be considered.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: cerebellar transcranial electrical stimulationIn the intervention group, the anodic stimulations will start after a ramp period of 30 s, followed by 20 min at 2 mili ampere and will end with a ramp of 30 s. |
| Placebo | Placebo comparator | Device: cerebellar transcranial electrical stimulationIn the simulated configuration, the ramp of 30 s will be immediately followed by the ramp of 30 s and without any current (Sham Group) |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 20-30 years
- participant of both sex
Key exclusion criteria (10 listed)
- history of neurological or psychological diseases;
- use of any medications that may affect balance control, such as sedative drugs;
- presence of skeletal muscle injuries such as fracture, ligament injury, muscle tension or low back pain that restricts movement;
- presence of any sign of involvement of the spinal cord;
- visual or hearing impairment;
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 |
|---|---|---|
| cerebellar transcranial electrical stimulationCerebellar transcranial electrical stimulation - 20 mA - 20 min | Device | Intervention, Placebo |
Primary outcome
Effect of tDCS on motor performance
Time frame: Through study completion, an average of 1 year
* Bilateral coordination of different walking conditions will be assessed by percentage (%) * The static equilibrium will be evaluated by the average amplitude of displacement of the center of pressure in mean lateral and anteroposterior directions (cm)
3 secondary outcomes
Effect of tDCS on functional mobility and dynamic balance
Time frame: Through study completion, an average of 1 year
Effect of variability of the heart rate
Time frame: Through study completion, an average of 1 year
Efect of tDCS on attentional and executive functions
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- 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.
Taís Malysz principal investigator
Federal University of Health Science of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cerebellar transcranial electrical stimulation in people with Healthy, run by Federal University of Rio Grande do Sul 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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 31 Oct 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 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Taís Malysz (+5551995890622, tais.malysz@ufrgs.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of tDCS on motor performance (time frame: Through study completion, an average of 1 year). 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 31 Oct 2023.