Basic PhysiologyNCT04148547
Transcranial Direct Current Stimulation (tDCS) in the Primary Motor Cortex in Healthy Individuals
A study testing Sooma transcranial direct current stimulation device in people with Basic Physiology and Brain Stimulation, run by Universidad Autonoma de Madrid at 1 site in Spain.
Trial summary
The main aim of this study is to assess the short-term effects of active-tDCS (a-tDCS) on the M1 regarding sensorimotor variables such as discriminative sensation, pressure pain threshold and electromyographic activity compared with a sham-tDCS (s-tDCS) in healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Basic Physiology, Brain Stimulation
- What is being tested?
- Sooma transcranial direct current stimulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2018to 30 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- asymptomatic participants
- men and women aged 18 to 65 years
Who cannot join
- insomnia
- nausea
- headache
- pregnancy
- use of painkillers in the last 24 hours
- presence of metal inside the head
Show all 10Show fewer
- pacemaker
- wound on the area of electrodes' application
- drug consumption; (j) recent application of tDCS
- psychiatric disease impeding understanding of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Direct Current Stimulation (tDCS) in the Primary Motor Cortex and Its Effects on Sensitivity, Pressure Pain Threshold, and Electromyographic Activity in Healthy Individuals: A Quasi-experimental Single-blind Sham-controlled Trial
The main aim of this study is to assess the short-term effects of active-tDCS (a-tDCS) on the M1 regarding sensorimotor variables such as discriminative sensation, pressure pain threshold and electromyographic activity compared with a sham-tDCS (s-tDCS) in healthy individuals. The main objective was to determine whether there were clinically relevant changes generated by tDCS and if they were superior to a sham intervention.
- Conditions
- Basic Physiology, Brain Stimulation
- Being tested
- Sooma transcranial direct current stimulation device, Placebo Sooma transcranial direct current stimulation device
- Keywords
- Transcranial direct current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sooma transcranial direct current stimulation deviceDevice
This group received brain training through transcranial direct current for 20 minutes.
Placebo Sooma transcranial direct current stimulation deviceDevice
This group received sham brain training through transcranial direct current for 20 minutes. The current is active for 15 seconds and then switches off until the intervention is finished.
| Study group | Role | What they receive |
|---|---|---|
| transcranial direct current stimulation | Experimental | Not described Receives: Device: Sooma transcranial direct current stimulation device |
| Sham transcranial direct current stimulation | Placebo comparator | Not described Receives: Device: Placebo Sooma transcranial direct current stimulation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain threshold through an algometer
Pressure pain threshold has been defined as the minimal amount of pressure at which a sense of pressure first changes to pain or discomfort
Measured: Change in pressure pain threshold immediately at the end of the intervention
Tactile acuity threshold
Tactile acuity threshold is an important variable to know the somatosensory state and Von Frey monofilaments and Aesthesiometer were used
Measured: Change in tactile acuity threshold immediately at the end of the intervention
Muscle recruitment through electromyographic activity
The activity of surface electromyography (sEMG) during an isometric maximal voluntary contraction was measured in the biceps brachii and rectus femoris.
Measured: Change in electromyographic activity immediately at the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start1 Sep 2018
- Primary completion1 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basic PhysiologyStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Universitario La Salle
- Responsible party
- Principal investigator, Roy La Touche Arbizu, Universidad Autonoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148547
- Sponsor's protocol ID
- uammadrid4
- Status last verified
- Oct 2019
- First submitted
- 30 Oct 2019
- Last updated
- 5 Nov 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 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) in the Primary Motor Cortex and Its Effects on Sensitivity, Pressure Pain Threshold, and Electromyographic Activity in Healthy Individuals: A Quasi-experimental Single-blind Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT04148547
- Acronym / sponsor ID
- uammadrid4
- Conditions
- Basic Physiology, Brain Stimulation
- Keywords
- Transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Collaborators
- Centro Universitario La Salle
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 1 Nov 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.
The main aim of this study is to assess the short-term effects of active-tDCS (a-tDCS) on the M1 regarding sensorimotor variables such as discriminative sensation, pressure pain threshold and electromyographic activity compared with a sham-tDCS (s-tDCS) in healthy individuals. The main objective was to determine whether there were clinically relevant changes generated by tDCS and if they were superior to a sham intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transcranial direct current stimulation | Experimental | Device: Sooma transcranial direct current stimulation device |
| Sham transcranial direct current stimulation | Placebo comparator | Device: Placebo Sooma transcranial direct current stimulation device |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- asymptomatic participants
- men and women aged 18 to 65 years
Key exclusion criteria (10 listed)
- insomnia
- nausea
- headache
- pregnancy
- use of painkillers in the last 24 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 |
|---|---|---|
| Sooma transcranial direct current stimulation deviceThis group received brain training through transcranial direct current for 20 minutes. | Device | transcranial direct current stimulation |
| Placebo Sooma transcranial direct current stimulation deviceThis group received sham brain training through transcranial direct current for 20 minutes. The current is active for 15 seconds and then switches off until the intervention is finished. | Device | Sham transcranial direct current stimulation |
Primary outcome
Pressure pain threshold through an algometer
Time frame: Change in pressure pain threshold immediately at the end of the intervention
Pressure pain threshold has been defined as the minimal amount of pressure at which a sense of pressure first changes to pain or discomfort
Tactile acuity threshold
Time frame: Change in tactile acuity threshold immediately at the end of the intervention
Tactile acuity threshold is an important variable to know the somatosensory state and Von Frey monofilaments and Aesthesiometer were used
Muscle recruitment through electromyographic activity
Time frame: Change in electromyographic activity immediately at the end of the intervention
The activity of surface electromyography (sEMG) during an isometric maximal voluntary contraction was measured in the biceps brachii and rectus femoris.
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 5 Nov 2019.
- Individual participant dataSharing planned: No
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 study testing Sooma transcranial direct current stimulation device in people with Basic Physiology and Brain Stimulation, run by Universidad Autonoma de Madrid 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 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: finished, as of the sponsor's last update on 5 Nov 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 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?
Pressure pain threshold through an algometer (time frame: Change in pressure pain threshold immediately at the end of the intervention). 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 5 Nov 2019; AzTrials last refreshed its copy on 30 Oct 2026.