HealthyNCT03486795
Dual Site-Dual Channel Non-invasive Brain Stimulation for Motor Function in Healthy Subjects
A study testing M1 stimulation and PMC stimulation in people with Healthy, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The aim of this study is to investigate the effect of dual site-dual channel non-invasive brain stimulation for recovery of motor function in healthy subjects. Simultaneous dual site-dual channel stimulation was applied by using two sets of transcranial direct current stimulation devices. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- M1 stimulation and PMC stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Oct 2017to 10 May 2018
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy subjects with age over 19 years old
Who cannot join
- history of disorders involving central nervous system
- patients with severe medial or psychiatric disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dual Site-Dual Channel Non-invasive Brain Stimulation for Recovery of Motor Function in Healthy Subjects
The aim of this study is to investigate the effect of dual site-dual channel non-invasive brain stimulation for recovery of motor function in healthy subjects. Simultaneous dual site-dual channel stimulation was applied by using two sets of transcranial direct current stimulation devices. All subjects will go through four conditions of transcranial direct current stimulation with for 30 minutes. Four conditions are 1) Dual stimulation: i) anodal stimulation on right primary motor cortex and cathodal stimulation on left primary motor cortex, ii) anodal stimulation on right premotor cortex and cathodal stimulation on left supraorbital area. 2) M1 stimulation: anodal stimulation on right primary motor cortex and cathodal stimulation on left primary motor cortex; 3) PMC stimulation: anodal stimulation on right premotor cortex and cathodal stimulation on left supraorbital area. 4) sham stimulation
- Conditions
- Healthy
- Being tested
- M1 stimulation, PMC stimulation, Sham stimulation
- Keywords
- transcranial direct current stimulation, motor function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M1 stimulationDevice
stimulating primary motor cortex with anodal stimulation on right primary motor cortex and cathodal stimulation on left primary motor cortex
PMC stimulationDevice
stimulating premotor cortex with anodal stimulation on right premotor cortex and cathodal stimulation on left supraorbital area
Sham stimulationDevice
sham stimulation over both primary motor cortex and premotor cortex
| Study group | Role | What they receive |
|---|---|---|
| Dual stimulation | Experimental | 1. anodal stimulation on right primary motor cortex and cathodal stimulation on left primary motor cortex
2. anodal stimulation on right premotor cortex and cathodal stimulation on left supraorbital area Receives: Device: M1 stimulation |
| M1 stimulation | Experimental | anodal stimulation on right primary motor cortex and cathodal stimulation on left primary motor cortex Receives: Device: M1 stimulation |
| PMC stimulation | Experimental | anodal stimulation on right premotor cortex and cathodal stimulation on left supraorbital area Receives: Device: PMC stimulation |
| Sham stimulation | Sham comparator | Sham stimulation Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in motor evoked potential
measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle
Measured: Baseline and after intervention (approximately 30 minutes)
Secondary outcomes (1)
Changes in sequential motor task
measures motor functional and dexterity of hand
Measured: Baseline and after intervention (approximately 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start31 Oct 2017
- Primary completion10 May 2018
- Study completion10 May 2018
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.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486795
- Sponsor's protocol ID
- 2017-08-124-C
- Status last verified
- Mar 2018
- First submitted
- 22 Mar 2018
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dual Site-Dual Channel Non-invasive Brain Stimulation for Recovery of Motor Function in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03486795
- Acronym / sponsor ID
- 2017-08-124-C
- Conditions
- Healthy
- Keywords
- transcranial direct current stimulation, motor function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 10 May 2018 (actual)
- Study completion
- 10 May 2018 (actual)
- First posted
- 3 Apr 2018 (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 dual site-dual channel non-invasive brain stimulation for recovery of motor function in healthy subjects. Simultaneous dual site-dual channel stimulation was applied by using two sets of transcranial direct current stimulation devices. All subjects will go through four conditions of transcranial direct current stimulation with for 30 minutes. Four conditions are 1) Dual stimulation: i) anodal stimulation on right primary motor cortex and cathodal stimulation on left primary motor cortex, ii) anodal stimulation on right premotor cortex and cathodal stimulation on left supraorbital area. 2) M1 stimulation: anodal stimulation on right primary motor cortex and cathodal stimulation on left primary motor cortex; 3) PMC stimulation: anodal stimulation on right premotor cortex and cathodal stimulation on left supraorbital area. 4) sham stimulation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dual stimulation | Experimental | Device: M1 stimulation1. anodal stimulation on right primary motor cortex and cathodal stimulation on left primary motor cortex 2. anodal stimulation on right premotor cortex and cathodal stimulation on left supraorbital area |
| M1 stimulation | Experimental | Device: M1 stimulationanodal stimulation on right primary motor cortex and cathodal stimulation on left primary motor cortex |
| PMC stimulation | Experimental | Device: PMC stimulationanodal stimulation on right premotor cortex and cathodal stimulation on left supraorbital area |
| Sham stimulation | Sham comparator | Device: Sham stimulationSham stimulation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy subjects with age over 19 years old
Key exclusion criteria (2 listed)
- history of disorders involving central nervous system
- patients with severe medial or psychiatric disease
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 |
|---|---|---|
| M1 stimulationstimulating primary motor cortex with anodal stimulation on right primary motor cortex and cathodal stimulation on left primary motor cortex | Device | Dual stimulation, M1 stimulation |
| PMC stimulationstimulating premotor cortex with anodal stimulation on right premotor cortex and cathodal stimulation on left supraorbital area | Device | PMC stimulation |
| Sham stimulationsham stimulation over both primary motor cortex and premotor cortex | Device | Sham stimulation |
Primary outcome
Changes in motor evoked potential
Time frame: Baseline and after intervention (approximately 30 minutes)
measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle
1 secondary outcome
Changes in sequential motor task
Time frame: Baseline and after intervention (approximately 30 minutes)
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 20 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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 study testing M1 stimulation and PMC stimulation in people with Healthy, run by Samsung Medical Center at 1 site in South Korea.
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 20 Sep 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 South Korea. 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?
Changes in motor evoked potential (time frame: Baseline and after intervention (approximately 30 minutes)). 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 20 Sep 2019.