Impulsive BehaviorNCT04290533
HD-tDCS Over the dACC in High Trait Impulsivity
A study testing Active High Definition transcranial Direct Current Stimulation (HD-tDCS) in people with Impulsive Behavior, run by Monash University at 1 site in Australia.
Trial summary
Psychological disorders characterized by impulsivity often show alterations in dorsal anterior cingulate cortex (dACC) activity. Recent research has therefore focused on non-invasive neurostimulation therapies for the modulation of functional activity in the dACC. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Impulsive Behavior
- What is being tested?
- Active High Definition transcranial Direct Current Stimulation (HD-tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteAustralia
- Study dates
- 4 Mar 2019to 15 Jan 2020
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Right-handed
- Score > 46 on SUPPS-P
Who cannot join
- Score low on trait impulsivity as determined by a score of < 47 on the SUPPS-P short form
- History of DSM-5 defined neurological illness, mental illness or traumatic brain injury,
- Currently taking any psychoactive medications,
- Have metal anywhere in the head, except the mouth. This includes metallic objects such as screws, plates and clips from surgical procedures.
- Currently pregnant or lactating,
- Being left-handed
Trial locations and contacts
1 site in 1 country.
About this study
Psychological disorders characterized by impulsivity often show alterations in dorsal anterior cingulate cortex (dACC) activity. Recent research has therefore focused on non-invasive neurostimulation therapies for the modulation of functional activity in the dACC. To date there has only been one proof-of-concept study providing evidence for modulating dACC activity with non-invasive electrical neurostimulation (e.g. transcranial electrical stimulation). Since transcranial Direct Current Stimulation (tDCS) is relatively safe, tolerable, and mobile as compared to other neurostimulation techniques, it is worthwhile looking further into the effects of tDCS on functional dACC activity. The aim of the present research is to explore whether HD-tDCS can induce changes in the dACC in individuals with high trait impulsivity (N=20) in a double-blind cross-over study. Functional changes in dACC activity will be measured by the error related negativity (ERN), which is an event related potential generated by the dACC. The ERN is less pronounced in people that score high on impulsivity. It is therefore expect enhanced ERN amplitudes after HD-tDCS over the dACC. In addition, performance on the multisource interference task will be used as measure of dACC activity. It is hypothesize that increased dACC activity will be related to decreased impulsivity in high impulsive individuals as shown by improved inhibitory control on the Go/NoGo task. The results of the study may have implications for patient populations that are characterized by impulsivity.
- Conditions
- Impulsive Behavior
- Being tested
- Active High Definition transcranial Direct Current Stimulation (HD-tDCS), Sham High Definition transcranial Direct Current Stimulation (HD-tDCS)
- Keywords
- Impulsivity, HD-tDCS, dACC, ERN, Go/NoGo, MSIT
- Medical subject headings
- Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active High Definition transcranial Direct Current Stimulation (HD-tDCS)Device
TDCS is a non-invasive neuromodulation technique that modulates membrane potentials by means of small electrical currents. Electrical currents induced by tDCS electrodes produce an electrical field that modulates the excitability of brain areas. In the present HD-tDCS montage, one anodal electrode and four return electrodes are applied. Hereby, the anodal electrode modulates the excitability of the targeted area, whereas the other 4 electrodes return electrical currents that flow away from that area. Direct currents will be transmitted through 5 circular PiStim electrodes of 3.14cm2 (Neuroelectrics, Barcelona, Spain; current density=0.32 mA/cm2) with a current intensity of 1.5 mA. The HD-tDCS session will last for 20 minutes in total, with a 60 sec ramp at the beginning and end of the session. The electrodes will be filled with conductive gel and plugged into an EEG cap, with the anode placed over Fz and the four return electrodes over Fp1, Fp2, F7, and F8 (10-20 system).
Sham High Definition transcranial Direct Current Stimulation (HD-tDCS)Device
For the sham-condition, the placement of the electrodes was identical to active HD-tDCS stimulation with the anode placed over Fz and the four return electrodes over Fp1, Fp2, F7, and F8 (10-20 system). The direct current, also transmitted through 5 circular PiStim electrodes of 3.14cm2 (Neuroelectrics, Barcelona, Spain; current density=0.32 mA/cm2), was increased in a ramp-like fashion over 60 seconds until it reached 1.5 mA. Directly after ramp-up, the current intensity was gradually switched off over 60 seconds, followed by 20 minutes without active stimulation. Sham procedures for tDCS mimic the transient skin sensation at the beginning of active HD-tDCS, without producing any conditioning effects on the brain. Consequently, participants are reliably blinded for sham tDCS.
| Study group | Role | What they receive |
|---|---|---|
| Active HD-tDCS | Experimental | Not described Receives: Device: Active High Definition transcranial Direct Current Stimulation (HD-tDCS) |
| Sham HD-tDCS | Sham comparator | Not described Receives: Device: Sham High Definition transcranial Direct Current Stimulation (HD-tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in error related negativity (ERN) measured by electroencephalography (EEG) after active and sham HD-tDCS
To measure changes in electrophysiological measures of error processing after active vs. sham HD-tDCS
Measured: Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
Change in NoGo N2 measured by electroencephalography (EEG)
To measure changes in electrophysiological measures of early inhibitory control processes after active vs. sham HD-tDCS
Measured: Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
Change in NoGo P3 measured by electroencephalography (EEG) after active and sham HD-tDCS
To measure changes in electrophysiological measures of motor inhibitory control processes after active vs. sham HD-tDCS
Measured: Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
Secondary outcomes (4)
Change in percentage of correct nogo trials on Go/NoGo task after active vs. sham HD-tDCS
To measure the effect of active vs. sham HD-tDCS on accuracy on trials for which responses have to be inhibited. Represents a measure of change in inhibitory control.
Measured: Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
Change in reaction times on Go trials during Go/NoGo task after active vs. sham HD-tDCS
To measure changes in speed of motor responses during Go/NoGo task differences after active vs. sham HD-tDCS
Measured: Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
Change in reaction times post incorrect trials during Go/NoGo task after active vs. sham HD-tDCS
To measure the effect of active vs. sham HD-tDCS on post-error slowing as behavioural measure of error processing.
Measured: Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
Change in interference effect on multisource interference task (MSIT) after active vs. sham HD-tDCS
The interference effect is calculated by subtracting the mean reaction time for congruent trials from the mean reaction time for incongruent trials. A larger interference effect reflects worse performance and is suggested to reflect decreased dACC activity.
Measured: Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start4 Mar 2019
- Primary completion15 Dec 2019
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impulsive BehaviorStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus University Rotterdam, ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Rebecca Segrave, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290533
- Sponsor's protocol ID
- 17612
- Status last verified
- May 2021
- First submitted
- 18 Feb 2020
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Verveer I, Hill AT, Franken IHA, Yucel M, van Dongen JDM, Segrave R. Modulation of control: Can HD-tDCS targeting the dACC reduce impulsivity? Brain Res. 2021 Apr 1;1756:147282. doi: 10.1016/j.brainres.2021.147282. Epub 2021 Jan 28.
PubMed 33515536
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HD-tDCS Over the dACC in High Trait Impulsivity
- ClinicalTrials.gov ID
- NCT04290533
- Acronym / sponsor ID
- 17612
- Conditions
- Impulsive Behavior
- Keywords
- Impulsivity, HD-tDCS, dACC, ERN, Go/NoGo, MSIT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Collaborators
- Erasmus University Rotterdam, ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 2 Mar 2020 (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.
Psychological disorders characterized by impulsivity often show alterations in dorsal anterior cingulate cortex (dACC) activity. Recent research has therefore focused on non-invasive neurostimulation therapies for the modulation of functional activity in the dACC. To date there has only been one proof-of-concept study providing evidence for modulating dACC activity with non-invasive electrical neurostimulation (e.g. transcranial electrical stimulation). Since transcranial Direct Current Stimulation (tDCS) is relatively safe, tolerable, and mobile as compared to other neurostimulation techniques, it is worthwhile looking further into the effects of tDCS on functional dACC activity. The aim of the present research is to explore whether HD-tDCS can induce changes in the dACC in individuals with high trait impulsivity (N=20) in a double-blind cross-over study. Functional changes in dACC activity will be measured by the error related negativity (ERN), which is an event related potential generated by the dACC. The ERN is less pronounced in people that score high on impulsivity. It is therefore expect enhanced ERN amplitudes after HD-tDCS over the dACC. In addition, performance on the multisource interference task will be used as measure of dACC activity. It is hypothesize that increased dACC activity will be related to decreased impulsivity in high impulsive individuals as shown by improved inhibitory control on the Go/NoGo task. The results of the study may have implications for patient populations that are characterized by impulsivity.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active HD-tDCS | Experimental | Device: Active High Definition transcranial Direct Current Stimulation (HD-tDCS) |
| Sham HD-tDCS | Sham comparator | Device: Sham High Definition transcranial Direct Current Stimulation (HD-tDCS) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Right-handed
- Score > 46 on SUPPS-P
Key exclusion criteria (6 listed)
- Score low on trait impulsivity as determined by a score of < 47 on the SUPPS-P short form
- History of DSM-5 defined neurological illness, mental illness or traumatic brain injury,
- Currently taking any psychoactive medications,
- Have metal anywhere in the head, except the mouth. This includes metallic objects such as screws, plates and clips from surgical procedures.
- Currently pregnant or lactating,
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 |
|---|---|---|
| Active High Definition transcranial Direct Current Stimulation (HD-tDCS)TDCS is a non-invasive neuromodulation technique that modulates membrane potentials by means of small electrical currents. Electrical currents induced by tDCS electrodes produce an electrical field that modulates the excitability of brain areas. In the present HD-tDCS montage, one anodal electrode and four return electrodes are applied. Hereby, the anodal electrode modulates the excitability of the targeted area, whereas the other 4 electrodes return electrical currents that flow away from that area. Direct currents will be transmitted through 5 circular PiStim electrodes of 3.14cm2 (Neuroelectrics, Barcelona, Spain; current density=0.32 mA/cm2) with a current intensity of 1.5 mA. The HD-tDCS session will last for 20 minutes in total, with a 60 sec ramp at the beginning and end of the session. The electrodes will be filled with conductive gel and plugged into an EEG cap, with the anode placed over Fz and the four return electrodes over Fp1, Fp2, F7, and F8 (10-20 system). | Device | Active HD-tDCS |
| Sham High Definition transcranial Direct Current Stimulation (HD-tDCS)For the sham-condition, the placement of the electrodes was identical to active HD-tDCS stimulation with the anode placed over Fz and the four return electrodes over Fp1, Fp2, F7, and F8 (10-20 system). The direct current, also transmitted through 5 circular PiStim electrodes of 3.14cm2 (Neuroelectrics, Barcelona, Spain; current density=0.32 mA/cm2), was increased in a ramp-like fashion over 60 seconds until it reached 1.5 mA. Directly after ramp-up, the current intensity was gradually switched off over 60 seconds, followed by 20 minutes without active stimulation. Sham procedures for tDCS mimic the transient skin sensation at the beginning of active HD-tDCS, without producing any conditioning effects on the brain. Consequently, participants are reliably blinded for sham tDCS. | Device | Sham HD-tDCS |
Primary outcome
Change in error related negativity (ERN) measured by electroencephalography (EEG) after active and sham HD-tDCS
Time frame: Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
To measure changes in electrophysiological measures of error processing after active vs. sham HD-tDCS
Change in NoGo N2 measured by electroencephalography (EEG)
Time frame: Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
To measure changes in electrophysiological measures of early inhibitory control processes after active vs. sham HD-tDCS
Change in NoGo P3 measured by electroencephalography (EEG) after active and sham HD-tDCS
Time frame: Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
To measure changes in electrophysiological measures of motor inhibitory control processes after active vs. sham HD-tDCS
4 secondary outcomes
Change in percentage of correct nogo trials on Go/NoGo task after active vs. sham HD-tDCS
Time frame: Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
Change in reaction times on Go trials during Go/NoGo task after active vs. sham HD-tDCS
Time frame: Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
Change in reaction times post incorrect trials during Go/NoGo task after active vs. sham HD-tDCS
Time frame: Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
Change in interference effect on multisource interference task (MSIT) after active vs. sham HD-tDCS
Time frame: Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
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 17 May 2021.
- Results publication: PubMed 33515536Verveer I, Hill AT, Franken IHA, Yucel M, van Dongen JDM, Segrave R. Modulation of control: Can HD-tDCS targeting the dACC reduce impulsivity? Brain Res. 2021 Apr 1;1756:147282. doi: 10.1016/j.brainres.2021.147282. Epub 2021 Jan 28.
- Individual participant dataSharing planned: No
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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 Active High Definition transcranial Direct Current Stimulation (HD-tDCS) in people with Impulsive Behavior, run by Monash University at 1 site in Australia.
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 6 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 17 May 2021. 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 Australia. 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 error related negativity (ERN) measured by electroencephalography (EEG) after active and sham HD-tDCS (time frame: Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.). 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?
On the ClinicalTrials.gov record for NCT04290533, which also lists 1 linked publication.
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 17 May 2021.