ClinicalTrials.gg
CompletedNCT03484377CDIC-tDCSUpdated Feb 25, 2020

Cortical Dynamics of Inhibitory Control: A Concurrent tDCS-MEG Study

An interventional study of Anodal tDCS and Sham tDCS in Impulsive Behavior, sponsored by Najat Khalifa. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-25.

Sponsored by Najat Khalifa · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Impulsive Behavior

Browse trials for

03

In context

Impulsive Behavior

158 studies on the registry are indexed under Impulsive Behavior; 31 are open to participants now.

This study's enrollment of 36 is below the median of 50 across 128 interventional studies indexed under Impulsive Behavior.

Browse Impulsive Behavior studies →

Lead sponsor

This is the only study on the registry with Najat Khalifa as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • University students and staff
  • Aged 18-40

Exclusion criteria

Exclusion Criteria:

  • Individuals with epilepsy and other neurological conditions, history of significant head injury, substance misuse, major mental disorder and those receiving psychotropic medication.
  • to use of Magnetic Resonance (pacemakers, metal implants, aneurysm clips)
  • Pregnancy.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Anodal tDCS

    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.

    Device: Anodal tDCS

  • Sham comparator
    Sham tDCS

    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.

    Device: Sham tDCS

Interventions

  • DeviceAnodal tDCS

    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.

  • DeviceSham tDCS

    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.

06

What researchers measure

Primary outcomes

  1. Total number of correct anti-saccade (AS) trials

    A measure of rapid response impulsivity (inhibitory control)

    Time frame: Change from baseline after 20 minutes of tDCS

Secondary outcomes

  1. Total number of correct pro-saccade (PS) trials

    A behavioral measure of rapid response impulsivity (inhibitory control)

    Time frame: Change from baseline after 20 minutes of tDCS

  2. Saccade latency for anti-saccade (AS) trials

    A behavioral measure of rapid response impulsivity (inhibitory control)

    Time frame: Change from baseline after 20 minutes of tDCS

  3. Saccade latency for pro-saccade (PS) trials

    A behavioral measure of rapid response impulsivity (inhibitory control)

    Time frame: Change from baseline after 20 minutes of tDCS

  4. Total Scores on the UPPS+P Impulsive Behaviour Scale

    A self-report measure of impulsivity

    Time frame: Baseline

  5. Alpha and Beta band activity

    A Cortical measure of inhibitory control recorded using Magnetoencephalography (MEG). MEG is a brain imaging technique.

    Time frame: Change from baseline after 20 minutes of tDCS

Other outcomes

  1. Alpha and Beta band activity

    Evaluation of mechanism of action of tDCS using MEG data

    Time frame: During 20 minutes of tDCS stimulation

07

Study locations

1 site
  • University of Nottingham
    Nottingham, Notts NG7 2TU, United Kingdom
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2018 to primary completion in Feb 2019, 4 months.

Of 55 non-industry interventional studies with no phase under Impulsive Behavior, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 34. This study's 4 months is below that.

Counting every sponsor, half of 55 studies reached it within 26 months; a quarter within 13 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 14, 2018
First posted
Mar 30, 2018
StartActual
Sep 15, 2018
Primary completionActual
Feb 14, 2019
CompletionActual
Feb 28, 2019
Last update
Feb 25, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03484377
Lead sponsor
Najat Khalifa
Collaborators
Medical Research Council, University of Nottingham
Responsible party
Najat Khalifa (Associate Professor, Nottinghamshire Healthcare NHS Trust) — Sponsor-investigator
First posted
Mar 30, 2018
Start date
Sep 15, 2018
Primary completion
Feb 14, 2019
Completion
Feb 28, 2019
Last update
Feb 25, 2020

Study contacts

Najat Khalifa, DM
principal investigator · University of Nottingham

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion