Transcranial Direct Current StimulationNCT03190590
Neurophysiological and Functional Mechanisms of Motor Control and Learning
A study testing tDCS-NeuroConn. and TMS - Magstim. in people with Transcranial Direct Current Stimulation, run by NYU Langone Health at 1 site in United States.
Trial summary
Noninvasive stimulation of the central nervous system, including transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), has been increasingly used in the investigation of cortical plasticity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transcranial Direct Current Stimulation
- What is being tested?
- tDCS-NeuroConn. and TMS - Magstim.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2018to 18 Jul 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Right-handed dominance
- Ability to give informed consent
Who cannot join
- active and/or chronic neurological, psychiatric (including depression), or medical conditions
- psychoactive medication use
- active drug/alcohol dependence or abuse history
- homelessness or other social situation that would preclude consistent visits
- history of head injury (including neurosurgery)
- history of seizure
Show all 9Show fewer
- inability to comprehend or participate in the procedures involved
- metal in the head (besides in mouth), such as implanted electrodes or devices, shrapnel, surgical clips, or fragments from welding/metalwork
- implanted devices (such as cardiac pacemakers, medical pumps, or intracardiac lines) in the thorax
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Noninvasive stimulation of the central nervous system, including transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), has been increasingly used in the investigation of cortical plasticity. The purpose of our study is to understand mechanistically-at the neurophysiological and systems levels-how the brain learns new motor skills. We propose to study the acquisition, consolidation, and retention of motor skill learning in healthy subjects. At the behavioral level, we will use movement kinematics to quantify and characterize movement, which allow us to infer functional strategies used by the brain to reduce movement errors. At a neurophysiological level, we will use TMS to document changes in cortical circuitry, which will allow us to infer neuroplastic changes possibly subserving these strategies. At a systems level, we will enhance motor system excitability using tDCS, which will enable us to infer the contribution of the stimulated area to the motor system's ability to learn new skills.
- Conditions
- Transcranial Direct Current Stimulation
- Being tested
- tDCS-NeuroConn., TMS - Magstim., Sham tDCS
- Keywords
- transcranial magnetic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS-NeuroConn.Procedure or surgery
tDCS is delivered noninvasively via electrodes applied to the surface of the head, and a mild electrical current is given during motor training.
TMS - Magstim.Procedure or surgery
TMS is delivered noninvasively via a hand-held coil applied to the surface of the head, and a magnetic pulse probes cortical circuitry [this is not repetitive TMS and so does NOT modulate brain excitability
Sham tDCSProcedure or surgery
delivered by briefly turning on and off the stimulator at the beginning of training, which mimics the sensation of true stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial direct current stimulator (tDCS) | Active comparator | tDCS is delivered noninvasively via electrodes applied to the surface of the head, and a mild electrical current is given during motor training. Receives: Procedure: tDCS-NeuroConn. |
| Transcranial magnetic stimulation (TMS) | Active comparator | TMS is delivered noninvasively via a hand-held coil applied to the surface of the head, and a magnetic pulse probes cortical circuitry [this is not repetitive TMS and so does NOT modulate brain excitability.] Receives: Procedure: TMS - Magstim. |
| Sham-tDCS | Placebo comparator | delivered by briefly turning on and off the stimulator at the beginning of training, which mimics the sensation of true stimulation. Receives: Procedure: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor skill gain from day 1 to day 5
defined as an improvement in performance accuracy at fixed movement speeds (see 5.2 for description of task and outcome). The delta in accuracy between day 1 and day 5 equates to motor skill learning.
Measured: 5 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start20 Mar 2018
- Primary completion18 Jul 2018
- Study completion18 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Direct Current StimulationStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heidi Schambra-Griesemer, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190590
- Sponsor's protocol ID
- 17-00328
- Status last verified
- Apr 2024
- First submitted
- 14 Jun 2017
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological and Functional Mechanisms of Motor Control and Learning
- ClinicalTrials.gov ID
- NCT03190590
- Acronym / sponsor ID
- 17-00328
- Conditions
- Transcranial Direct Current Stimulation
- Keywords
- transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 18 Jul 2018 (actual)
- Study completion
- 18 Jul 2018 (actual)
- First posted
- 19 Jun 2017 (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.
Noninvasive stimulation of the central nervous system, including transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), has been increasingly used in the investigation of cortical plasticity. The purpose of our study is to understand mechanistically-at the neurophysiological and systems levels-how the brain learns new motor skills. We propose to study the acquisition, consolidation, and retention of motor skill learning in healthy subjects. At the behavioral level, we will use movement kinematics to quantify and characterize movement, which allow us to infer functional strategies used by the brain to reduce movement errors. At a neurophysiological level, we will use TMS to document changes in cortical circuitry, which will allow us to infer neuroplastic changes possibly subserving these strategies. At a systems level, we will enhance motor system excitability using tDCS, which will enable us to infer the contribution of the stimulated area to the motor system's ability to learn new skills.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transcranial direct current stimulator (tDCS) | Active comparator | Procedure: tDCS-NeuroConn.tDCS is delivered noninvasively via electrodes applied to the surface of the head, and a mild electrical current is given during motor training. |
| Transcranial magnetic stimulation (TMS) | Active comparator | Procedure: TMS - Magstim.TMS is delivered noninvasively via a hand-held coil applied to the surface of the head, and a magnetic pulse probes cortical circuitry [this is not repetitive TMS and so does NOT modulate brain excitability.] |
| Sham-tDCS | Placebo comparator | Procedure: Sham tDCSdelivered by briefly turning on and off the stimulator at the beginning of training, which mimics the sensation of true stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Right-handed dominance
- Ability to give informed consent
Key exclusion criteria (9 listed)
- active and/or chronic neurological, psychiatric (including depression), or medical conditions
- psychoactive medication use
- active drug/alcohol dependence or abuse history
- homelessness or other social situation that would preclude consistent visits
- history of head injury (including neurosurgery)
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 |
|---|---|---|
| tDCS-NeuroConn.tDCS is delivered noninvasively via electrodes applied to the surface of the head, and a mild electrical current is given during motor training. | Procedure or surgery | Transcranial direct current stimulator (tDCS) |
| TMS - Magstim.TMS is delivered noninvasively via a hand-held coil applied to the surface of the head, and a magnetic pulse probes cortical circuitry [this is not repetitive TMS and so does NOT modulate brain excitability | Procedure or surgery | Transcranial magnetic stimulation (TMS) |
| Sham tDCSdelivered by briefly turning on and off the stimulator at the beginning of training, which mimics the sensation of true stimulation. | Procedure or surgery | Sham-tDCS |
Primary outcome
Motor skill gain from day 1 to day 5
Time frame: 5 Days
defined as an improvement in performance accuracy at fixed movement speeds (see 5.2 for description of task and outcome). The delta in accuracy between day 1 and day 5 equates to motor skill learning.
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 29 Apr 2024.
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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.
Heidi Schambra-Griesemer, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS-NeuroConn. and TMS - Magstim. in people with Transcranial Direct Current Stimulation, run by NYU Langone Health at 1 site in United States.
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 9 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 29 Apr 2024. 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 United States. 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?
Motor skill gain from day 1 to day 5 (time frame: 5 Days). 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 29 Apr 2024.