Transcranial Direct Current StimulationPhase 3DOPA-STIMNCT02402101
Effect of the Transcranial Direct Current Stimulation on the Dopaminergic Transmission in Healthy Subjects
A Phase 3 study testing Procedure: active tDCS in people with Transcranial Direct Current Stimulation and Dopamine, run by Hôpital le Vinatier at 1 site in France.
Trial summary
Transcranial direct current stimulation (tDCS) is a technique that is emerging as a prospective therapy for neurologic, psychiatric and addictive disorders. Specifically, anodal tDCS applied over the dorsolateral prefrontal cortex (DLPFC) is associated with improvement of cognitive functions and mood. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Transcranial Direct Current Stimulation, Dopamine
- What is being tested?
- Procedure: active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Aug 2016
- Phase
- Phase 3
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non smoker
- No pyschotrope consumption
- No medical treatment
- No psychiatric or somatic (neurological, endocrine, cardiac, renal)
- Affiliated to the french social security
Who cannot join
- No consent
- For females : Pregnant or without birth control
- Contraindications to stimulation by tDCS or to an MRI exam
- Being in an exclusion period or over the annual compensation ceiling
- Participation in another study using ionizing radiation in less than a year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Transcranial Direct Current Stimulation on the Dopaminergic
Transcranial direct current stimulation (tDCS) is a technique that is emerging as a prospective therapy for neurologic, psychiatric and addictive disorders. Specifically, anodal tDCS applied over the dorsolateral prefrontal cortex (DLPFC) is associated with improvement of cognitive functions and mood. Despite an increased use in clinical settings, tDCS suffers from limitations, especially regarding the strength and the duration of therapeutic effects. Strategies to optimize the conditions for tDCS application suffer from the lack of knowledge about its neurophysiological impact. Moreover, tDCS is increasingly used in private settings through commercial apparatus and tutorials to make a "do-it-yourself" device delivering tDCS now available on the Internet. This private use worries neuroscientists and health authorities. Even if the general impression is that, in controlled conditions, tDCS is safe with only mild and transient adverse effects, whether and how tDCS could be used for enhancing cognition in healthy subjects are needed to investigate in more detail. The investigators believe that a better understanding of some neurobiological effects of tDCS is crucial to further tailor tDCS for experimental and therapeutic applications and to define recommendations for a private use.
As the cortex is densely connected with basal ganglia areas, including dopaminergic areas, tDCS is probably not only capable to target cortical but also subcortical structures remote from the stimulation sites. Some studies suggest that cortical stimulation by other approaches, such as transcranial magnetic stimulation (rTMS) leads to an increased dopaminergic transmission. The involvement of dopaminergic systems in tDCS effects has been investigated only indirectly in pharmacological studies. Thus, the direct effect of the DLPFC stimulation by tDCS on dopaminergic transmission is still unknown.
The aim of this project is to reveal the online impact of a single-session of tDCS applied bilaterally over the DLPFC in healthy subjects on the dopaminergic transmission measured by PET, combined with the [11C]raclopride bolus-plus-continuous-infusion method.
- Conditions
- Transcranial Direct Current Stimulation, Dopamine
- Being tested
- Procedure: active tDCS, Procedure: sham tDCS
- Keywords
- tDCS, Dopamine, PET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure: active tDCSDevice
Intensity 2 mA during 20 minutes
Procedure: sham tDCSDevice
Also called tDCS placebo
sham condition as delivered by the stimulator
| Study group | Role | What they receive |
|---|---|---|
| active tDCS | Active comparator | Intensity : 2mA Duration : 20 minutes ramp up/ramp down 30sec anodal tDCS applied over the left DLPFC cathodal tDCS applied over the right DLPFC Receives: Device: Procedure: active tDCS |
| sham tDCS | Placebo comparator | Placebo built-in mode (30 sec ramp periods at the beginning and the end of the sham stimulation to mimic the somatosensory artifact of real tDCS) Same electrode montage than in the active group. Receives: Device: Procedure: sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dopamine transmission after 1 session of 20min tDCS
Measure of the Binding Ratio defined as the ratio of : region of interest / cerebellum activities)
Measured: during 100min of PET scan : Baseline (20-40min), during stimulation (40-60min) and after stimulation (60-80min & 80-100min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2016
- Study completionAug 2016
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 Hôpital le VinatierThe 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 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic Haesebaert, PH, Principal investigator, CH Le Vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402101
- Sponsor's protocol ID
- 2014-A01405-42
- Acronym
- DOPA-STIM
- Status last verified
- Aug 2016
- First submitted
- 18 Mar 2015
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Transcranial Direct Current Stimulation on the Dopaminergic
- ClinicalTrials.gov ID
- NCT02402101
- Acronym / sponsor ID
- DOPA-STIM / 2014-A01405-42
- Conditions
- Transcranial Direct Current Stimulation, Dopamine
- Keywords
- tDCS, Dopamine, PET
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 30 Mar 2015 (estimated)
- 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.
Transcranial direct current stimulation (tDCS) is a technique that is emerging as a prospective therapy for neurologic, psychiatric and addictive disorders. Specifically, anodal tDCS applied over the dorsolateral prefrontal cortex (DLPFC) is associated with improvement of cognitive functions and mood. Despite an increased use in clinical settings, tDCS suffers from limitations, especially regarding the strength and the duration of therapeutic effects. Strategies to optimize the conditions for tDCS application suffer from the lack of knowledge about its neurophysiological impact. Moreover, tDCS is increasingly used in private settings through commercial apparatus and tutorials to make a "do-it-yourself" device delivering tDCS now available on the Internet. This private use worries neuroscientists and health authorities. Even if the general impression is that, in controlled conditions, tDCS is safe with only mild and transient adverse effects, whether and how tDCS could be used for enhancing cognition in healthy subjects are needed to investigate in more detail. The investigators believe that a better understanding of some neurobiological effects of tDCS is crucial to further tailor tDCS for experimental and therapeutic applications and to define recommendations for a private use.
As the cortex is densely connected with basal ganglia areas, including dopaminergic areas, tDCS is probably not only capable to target cortical but also subcortical structures remote from the stimulation sites. Some studies suggest that cortical stimulation by other approaches, such as transcranial magnetic stimulation (rTMS) leads to an increased dopaminergic transmission. The involvement of dopaminergic systems in tDCS effects has been investigated only indirectly in pharmacological studies. Thus, the direct effect of the DLPFC stimulation by tDCS on dopaminergic transmission is still unknown.
The aim of this project is to reveal the online impact of a single-session of tDCS applied bilaterally over the DLPFC in healthy subjects on the dopaminergic transmission measured by PET, combined with the [11C]raclopride bolus-plus-continuous-infusion method.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active tDCS | Active comparator | Device: Procedure: active tDCSIntensity : 2mA Duration : 20 minutes ramp up/ramp down 30sec anodal tDCS applied over the left DLPFC cathodal tDCS applied over the right DLPFC |
| sham tDCS | Placebo comparator | Device: Procedure: sham tDCSPlacebo built-in mode (30 sec ramp periods at the beginning and the end of the sham stimulation to mimic the somatosensory artifact of real tDCS) Same electrode montage than in the active group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Non smoker
- No pyschotrope consumption
- No medical treatment
- No psychiatric or somatic (neurological, endocrine, cardiac, renal)
- Affiliated to the french social security
Key exclusion criteria (5 listed)
- No consent
- For females : Pregnant or without birth control
- Contraindications to stimulation by tDCS or to an MRI exam
- Being in an exclusion period or over the annual compensation ceiling
- Participation in another study using ionizing radiation in less than a year
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 |
|---|---|---|
| Procedure: active tDCSIntensity 2 mA during 20 minutes | Device | active tDCS |
| Procedure: sham tDCSAlso: tDCS placebosham condition as delivered by the stimulator | Device | sham tDCS |
Primary outcome
Change in dopamine transmission after 1 session of 20min tDCS
Time frame: during 100min of PET scan : Baseline (20-40min), during stimulation (40-60min) and after stimulation (60-80min & 80-100min)
Measure of the Binding Ratio defined as the ratio of : region of interest / cerebellum activities)
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 Aug 2016.
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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.
Frederic Haesebaert, PH principal investigator
CH Le Vinatier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Procedure: active tDCS in people with Transcranial Direct Current Stimulation and Dopamine, run by Hôpital le Vinatier at 1 site in France.
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 5 inclusion and 5 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 Aug 2016. 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 dopamine transmission after 1 session of 20min tDCS (time frame: during 100min of PET scan : Baseline (20-40min), during stimulation (40-60min) and after stimulation (60-80min & 80-100min)). 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 Aug 2016.