HealthyNCT03931512
TDCS Effects on Motor Learning and Motor Control in Healthy Subjetcs
A study testing transcranial direct current stimularion in people with Healthy, run by Centro Universitario La Salle at 1 site in Spain.
Trial summary
Clinical Trial with two groups, transcranial direct current stimulation aplication and sham; triple blinded. The protocol is applied 5 consecutive days during the training of a manual dexterity task. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- transcranial direct current stimularion
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteSpain
- Study dates
- 30 Apr 2019to 1 Jun 2019
- 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
- healthy volunteers
Who cannot join
- metal or skin lesions on the head
- brain stimulation in the last 6 months
- family history of epilepsy or seizures
- pacemaker or any cardiac involvement
- inability to understand or execute the task
- taking drugs that may influence cognition
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Direct Current Stimulation Effects on Motor Learning and Motor Control in Healthy Subjetcs
Clinical Trial with two groups, transcranial direct current stimulation aplication and sham; triple blinded. The protocol is applied 5 consecutive days during the training of a manual dexterity task. Manual dexterity and somatosensory variables are measured pre intervention, post one day of intervention, post 5 days of intervention, and 5 days after finish the intervention.
Read the detailed description
Clinical Trial with two groups, transcranial direct current stimulation aplication (1 mA ) and sham (ramp up and down of 30 seconds in total) . Bouth interventions will last 20 minutes; at the same time of the aplication bouth are going to train the manual dexterity with Purdue Pegboard Test.
This protocol is applied 5 consecutive days, also it have a follow up of 5 days more.
It is triple blinded. Manual dexterity and somatosensory variables are measured pre intervention, post one day of intervention, post 5 days of intervention, and 5 days after finish the intervention.
- Conditions
- Healthy
- Being tested
- transcranial direct current stimularion
- Keywords
- transcranial direct current stimulation, motor learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimularionDevice
aplication of direct current stimulation on the scalp wiht sponge electrodes
| Study group | Role | What they receive |
|---|---|---|
| transcranial direct current stimulation | Experimental | 20 minutes of transcranial direct current stimulation
1 mA on bi-hemispheric colocation with cathode on the left M1 and anode on the right M1 Receives: Device: transcranial direct current stimularion |
| sham transcrial direct current stimulation | Sham comparator | 20 minutes positioning the electrodes on the scalp. Whith an initial increasing of the current intensity by 10 seconds, until 1mA and a ramp down from 20 seconds to reach zero. Receives: Device: transcranial direct current stimularion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in trained manual dexterity of the dominant hand
One hand manual dexterity is measured with Perdue Pegboard test
Measured: pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention
Secondary outcomes (9)
Changes in trained manual dexterity of bouth hands
Two hands dexterity is measured with Perdue Pegboard test
Measured: pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention
Changes in maximal isometric hand grip force
Hand grip force is measured with Jamar dinamometer
Measured: pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention
Sleep Quality
Pittsburgh Sleep Quality Index
Measured: 5 days after finish the intervention
Physical activity
Long form of the International Physical Activity Questionnaire
Measured: 5 days after finish the intervention
Changes in nontrained manual dexterity of the dominant hand
One hand dexterity is mesured with Minesota Test
Measured: pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention
Changes in nontrained manual dexterity of bouth hands
Two hands dexterity is mesured with Minesota Test
Measured: pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention
Changes in pressure detection treshold
The pressure detection treshold is measured with an algometer
Measured: pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention
Changes in pain detection treshold
The pain detection treshold is measured with an algometer
Measured: pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention
Changes in two points discrimination
Two points discrimination is measured with an esthesiometer
Measured: pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start30 Apr 2019
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitario La Salle
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Flix Díez, Centro Universitario La Salle
- Investigators
- Sergio Lerma Lara, PhD, Principal investigator, University Studies Center La Salle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931512
- Sponsor's protocol ID
- R-0022/18
- Status last verified
- Jun 2022
- First submitted
- 8 Apr 2019
- Last updated
- 23 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual praticipant data is going to be anonymized. Also, the participants are going to sing the consent of shareing his personal data.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation Effects on Motor Learning and Motor Control in Healthy Subjetcs
- ClinicalTrials.gov ID
- NCT03931512
- Acronym / sponsor ID
- R-0022/18
- Conditions
- Healthy
- Keywords
- transcranial direct current stimulation, motor learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Centro Universitario La SalleUniversity, hospital or other
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 30 Apr 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.
Clinical Trial with two groups, transcranial direct current stimulation aplication and sham; triple blinded. The protocol is applied 5 consecutive days during the training of a manual dexterity task. Manual dexterity and somatosensory variables are measured pre intervention, post one day of intervention, post 5 days of intervention, and 5 days after finish the intervention.
Detailed description
Clinical Trial with two groups, transcranial direct current stimulation aplication (1 mA ) and sham (ramp up and down of 30 seconds in total) . Bouth interventions will last 20 minutes; at the same time of the aplication bouth are going to train the manual dexterity with Purdue Pegboard Test.
This protocol is applied 5 consecutive days, also it have a follow up of 5 days more.
It is triple blinded. Manual dexterity and somatosensory variables are measured pre intervention, post one day of intervention, post 5 days of intervention, and 5 days after finish the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transcranial direct current stimulation | Experimental | Device: transcranial direct current stimularion20 minutes of transcranial direct current stimulation 1 mA on bi-hemispheric colocation with cathode on the left M1 and anode on the right M1 |
| sham transcrial direct current stimulation | Sham comparator | Device: transcranial direct current stimularion20 minutes positioning the electrodes on the scalp. Whith an initial increasing of the current intensity by 10 seconds, until 1mA and a ramp down from 20 seconds to reach zero. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (7 listed)
- metal or skin lesions on the head
- brain stimulation in the last 6 months
- family history of epilepsy or seizures
- pacemaker or any cardiac involvement
- inability to understand or execute the task
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 stimularionaplication of direct current stimulation on the scalp wiht sponge electrodes | Device | sham transcrial direct current stimulation, transcranial direct current stimulation |
Primary outcome
Change in trained manual dexterity of the dominant hand
Time frame: pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention
One hand manual dexterity is measured with Perdue Pegboard test
9 secondary outcomes
Changes in trained manual dexterity of bouth hands
Time frame: pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention
Changes in maximal isometric hand grip force
Time frame: pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention
Sleep Quality
Time frame: 5 days after finish the intervention
Physical activity
Time frame: 5 days after finish the intervention
Changes in nontrained manual dexterity of the dominant hand
Time frame: pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention
Changes in nontrained manual dexterity of bouth hands
Time frame: pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention
Changes in pressure detection treshold
Time frame: pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention
Changes in pain detection treshold
Time frame: pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention
Changes in two points discrimination
Time frame: pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention
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 23 Jun 2022.
- Individual participant dataSharing planned: Yes. The individual praticipant data is going to be anonymized. Also, the participants are going to sing the consent of shareing his personal data.
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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.
Sergio Lerma Lara, PhD principal investigator
University Studies Center La Salle
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 stimularion in people with Healthy, run by Centro Universitario La Salle at 1 site in Spain.
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 7 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 23 Jun 2022. 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 Spain. 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 trained manual dexterity of the dominant hand (time frame: pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention). 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 23 Jun 2022.