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

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ClinicalTrials.gov Identifier: NCT03484377
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : August 21, 2019
Sponsor:
Collaborators:
Medical Research Council
University of Nottingham
Information provided by (Responsible Party):
Najat Khalifa, Nottinghamshire Healthcare NHS Trust

Brief 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.

Condition or disease Intervention/treatment Phase
Impulsive Behavior Device: Anodal tDCS Device: Sham tDCS Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Concurrent tDCS-MEG parallel arms single-blinded experimental design (right anodal v sham tDCS).
Masking: Single (Participant)
Masking Description: Participants will be randomly allocated, using a computer generated code, to receive either anodal tDCS or sham. For sham stimulation, 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
Primary Purpose: Treatment
Official Title: Measuring Cortical Dynamics of Inhibitory Control Before, During and After Transcranial Direct Current Stimulation (tDCS)
Actual Study Start Date : September 15, 2018
Estimated Primary Completion Date : October 14, 2019
Estimated Study Completion Date : December 14, 2019

Arm Intervention/treatment
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
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 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
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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Total number of correct pro-saccade (PS) trials [ Time Frame: Change from baseline after 20 minutes of tDCS ]
    A behavioral measure of rapid response impulsivity (inhibitory control)

  2. Saccade latency for anti-saccade (AS) trials [ Time Frame: Change from baseline after 20 minutes of tDCS ]
    A behavioral measure of rapid response impulsivity (inhibitory control)

  3. Saccade latency for pro-saccade (PS) trials [ Time Frame: Change from baseline after 20 minutes of tDCS ]
    A behavioral measure of rapid response impulsivity (inhibitory control)

  4. Total Scores on the UPPS+P Impulsive Behaviour Scale [ Time Frame: Baseline ]
    A self-report measure of impulsivity

  5. Alpha and Beta band activity [ Time Frame: Change from baseline after 20 minutes of tDCS ]
    A Cortical measure of inhibitory control recorded using Magnetoencephalography (MEG). MEG is a brain imaging technique.


Other Outcome Measures:
  1. Alpha and Beta band activity [ Time Frame: During 20 minutes of tDCS stimulation ]
    Evaluation of mechanism of action of tDCS using MEG data



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • University students and staff
  • Aged 18-40

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03484377


Contacts
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Contact: Najat R Khalifa, DM +44(0)1158231269 nrk2@queensu.ca
Contact: Katy Jones, PhD +44(0)115 82 30418 katy.jones@nottingham.ac.uk

Locations
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United Kingdom
University of Nottingham Recruiting
Nottingham, Notts, United Kingdom, NG7 2TU
Contact: Katy Jones       katy.kones@nottingham.ac.uk   
Sponsors and Collaborators
Najat Khalifa
Medical Research Council
University of Nottingham
Investigators
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Principal Investigator: Najat Khalifa, DM University of Nottingham
  Study Documents (Full-Text)

Documents provided by Najat Khalifa, Nottinghamshire Healthcare NHS Trust:
Study Protocol  [PDF] January 8, 2018


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Responsible Party: Najat Khalifa, Associate Professor, Nottinghamshire Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT03484377     History of Changes
Other Study ID Numbers: CiC2017051
199-1801 ( Other Identifier: Research Ethics - University of Nottingham )
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Impulsive Behavior