Impulsive BehaviorCDIC-tDCSNCT03484377
Cortical Dynamics of Inhibitory Control: A Concurrent tDCS-MEG Study
A study testing Anodal tDCS in people with Impulsive Behavior, run by Najat Khalifa at 1 site in United Kingdom.
Trial summary
This study aims to use concurrent Transcranial Direct Current Stimulation (tDCS) and Magnetoencephalography (MEG) with measures of impulsivity to examine the neurobiological underpinnings of rapid response impulsivity (RRI) and how these can be modified using tDCS in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Impulsive Behavior
- What is being tested?
- Anodal 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 siteUnited Kingdom
- Study dates
- 15 Sep 2018to 28 Feb 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- University students and staff
- Aged 18-40
Who cannot join
- Individuals with epilepsy and other neurological conditions, history of significant head injury, substance misuse, major mental disorder and those receiving psychotropic medication.
- Contraindications to use of Magnetic Resonance (pacemakers, metal implants, aneurysm clips)
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham
Nottingham, Notts, NG7 2TU
About this study
Official title: Measuring Cortical Dynamics of Inhibitory Control Before, During and After Transcranial Direct Current Stimulation (tDCS)
This study aims to use concurrent Transcranial Direct Current Stimulation (tDCS) and Magnetoencephalography (MEG) with measures of impulsivity to examine the neurobiological underpinnings of rapid response impulsivity (RRI) and how these can be modified using tDCS in healthy subjects.
Read the detailed description
Concurrent tDCS-MEG parallel arms single-blinded experimental design (right anodal v sham tDCS) will be employed in this study. The study will be conducted at the University of Nottingham, using a sample of student volunteers. This study aims to examine the influence of anodal tDCS on beta-band and alpha-band oscillatory activities, using an anti-saccade task administered before, during and after tDCS stimulation. It can potentially help understand the neurobiological mechanisms underpinning rapid response impulsivity and how these can be influenced by tDCS.
The research hypotheses are that (i) a generalised mechanism for top-down inhibitory control will play a vital role, whereby prefrontal beta-band activity initiates alpha-band activity for functional inhibition over the frontal eye fields and other areas in the neurocircuitry involved in RRI; (ii) anodal tDCS (as opposed to sham) delivered over the right DLPFC will enhance this mechanism; and (iii) there will be no significant correlations between measures of self-report impulsivity and performance on the anti-saccade task and measures of oscillatory activity.
- Conditions
- Impulsive Behavior
- Being tested
- Anodal tDCS, Sham tDCS
- Medical subject headings
- Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal tDCSDevice
The experimental condition will use a constant current of 2mA for 20 minutes, delivered via gradual increase and decrease over 10 seconds at the onset and offset of stimulation (current ramps), respectively.
Sham tDCSDevice
The anodal electrode will be placed over the supreorbital ridge. The current will be delivered only in the first 10 seconds, after which the stimulation will cease but with the electrodes still in place throughout the session. The session will last for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS | Experimental | The anodal tDCS electrode will be placed over the area corresponding to the right DLPFC (F4 of the EEG10-20 international system). The anodal tDCS condition will use a constant current of 2mA, delivered via gradual increase and decrease over 10 seconds at the onset and offset of stimulation (current ramps), respectively. Receives: Device: Anodal tDCS |
| Sham tDCS | Sham comparator | The sham (cathodal) electrode will be placed over the left supraorbital ridge. The current will be delivered only in the first 10 seconds, after which the stimulation will cease but with the electrodes still in place throughout the session. Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of correct anti-saccade (AS) trials
A measure of rapid response impulsivity (inhibitory control)
Measured: Change from baseline after 20 minutes of tDCS
Secondary outcomes (5)
Total number of correct pro-saccade (PS) trials
A behavioral measure of rapid response impulsivity (inhibitory control)
Measured: Change from baseline after 20 minutes of tDCS
Saccade latency for anti-saccade (AS) trials
A behavioral measure of rapid response impulsivity (inhibitory control)
Measured: Change from baseline after 20 minutes of tDCS
Saccade latency for pro-saccade (PS) trials
A behavioral measure of rapid response impulsivity (inhibitory control)
Measured: Change from baseline after 20 minutes of tDCS
Total Scores on the UPPS+P Impulsive Behaviour Scale
A self-report measure of impulsivity
Measured: Baseline
Alpha and Beta band activity
A Cortical measure of inhibitory control recorded using Magnetoencephalography (MEG). MEG is a brain imaging technique.
Measured: Change from baseline after 20 minutes of tDCS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start15 Sep 2018
- Primary completion14 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Concurrent tDCS-MEG parallel arms single-blinded experimental design (right anodal v sham tDCS).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Najat Khalifa
- Sponsor type
- Other government
- Collaborators
- Medical Research Council, University of Nottingham
- Responsible party
- Sponsor-investigator, Najat Khalifa, Nottinghamshire Healthcare NHS Trust
- Investigators
- Najat Khalifa, DM, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484377
- Sponsor's protocol ID
- CiC2017051
- Other IDs
- 199-1801
- Acronym
- CDIC-tDCS
- Status last verified
- Feb 2020
- First submitted
- 14 Mar 2018
- Last updated
- 25 Feb 2020
- 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 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Cortical Dynamics of Inhibitory Control Before, During and After Transcranial Direct Current Stimulation (tDCS)
- ClinicalTrials.gov ID
- NCT03484377
- Acronym / sponsor ID
- CDIC-tDCS / CiC2017051
- Conditions
- Impulsive Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Najat KhalifaOther government
- Collaborators
- Medical Research Council, University of Nottingham
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 14 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 30 Mar 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.
This study aims to use concurrent Transcranial Direct Current Stimulation (tDCS) and Magnetoencephalography (MEG) with measures of impulsivity to examine the neurobiological underpinnings of rapid response impulsivity (RRI) and how these can be modified using tDCS in healthy subjects.
Detailed description
Concurrent tDCS-MEG parallel arms single-blinded experimental design (right anodal v sham tDCS) will be employed in this study. The study will be conducted at the University of Nottingham, using a sample of student volunteers. This study aims to examine the influence of anodal tDCS on beta-band and alpha-band oscillatory activities, using an anti-saccade task administered before, during and after tDCS stimulation. It can potentially help understand the neurobiological mechanisms underpinning rapid response impulsivity and how these can be influenced by tDCS.
The research hypotheses are that (i) a generalised mechanism for top-down inhibitory control will play a vital role, whereby prefrontal beta-band activity initiates alpha-band activity for functional inhibition over the frontal eye fields and other areas in the neurocircuitry involved in RRI; (ii) anodal tDCS (as opposed to sham) delivered over the right DLPFC will enhance this mechanism; and (iii) there will be no significant correlations between measures of self-report impulsivity and performance on the anti-saccade task and measures of oscillatory activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Concurrent tDCS-MEG parallel arms single-blinded experimental design (right anodal v sham tDCS).
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS | Experimental | Device: Anodal tDCSThe anodal tDCS electrode will be placed over the area corresponding to the right DLPFC (F4 of the EEG10-20 international system). The anodal tDCS condition will use a constant current of 2mA, delivered via gradual increase and decrease over 10 seconds at the onset and offset of stimulation (current ramps), respectively. |
| Sham tDCS | Sham comparator | Device: Sham tDCSThe sham (cathodal) electrode will be placed over the left supraorbital ridge. The current will be delivered only in the first 10 seconds, after which the stimulation will cease but with the electrodes still in place throughout the session. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- University students and staff
- Aged 18-40
Key exclusion criteria (3 listed)
- Individuals with epilepsy and other neurological conditions, history of significant head injury, substance misuse, major mental disorder and those receiving psychotropic medication.
- Contraindications to use of Magnetic Resonance (pacemakers, metal implants, aneurysm clips)
- Pregnancy.
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 |
|---|---|---|
| Anodal tDCSThe experimental condition will use a constant current of 2mA for 20 minutes, delivered via gradual increase and decrease over 10 seconds at the onset and offset of stimulation (current ramps), respectively. | Device | Anodal tDCS |
| Sham tDCSThe anodal electrode will be placed over the supreorbital ridge. The current will be delivered only in the first 10 seconds, after which the stimulation will cease but with the electrodes still in place throughout the session. The session will last for 20 minutes. | Device | Sham tDCS |
Primary outcome
Total number of correct anti-saccade (AS) trials
Time frame: Change from baseline after 20 minutes of tDCS
A measure of rapid response impulsivity (inhibitory control)
5 secondary outcomes
Total number of correct pro-saccade (PS) trials
Time frame: Change from baseline after 20 minutes of tDCS
Saccade latency for anti-saccade (AS) trials
Time frame: Change from baseline after 20 minutes of tDCS
Saccade latency for pro-saccade (PS) trials
Time frame: Change from baseline after 20 minutes of tDCS
Total Scores on the UPPS+P Impulsive Behaviour Scale
Time frame: Baseline
Alpha and Beta band activity
Time frame: Change from baseline after 20 minutes of 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 25 Feb 2020.
- 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.
Najat Khalifa, DM principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal tDCS in people with Impulsive Behavior, run by Najat Khalifa at 1 site in United Kingdom.
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 3 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 25 Feb 2020. 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 Kingdom. 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?
Total number of correct anti-saccade (AS) trials (time frame: Change from baseline after 20 minutes of tDCS). 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 25 Feb 2020; AzTrials last refreshed its copy on 30 Oct 2026.