Cortical Dynamics of Inhibitory Control: A Concurrent tDCS-MEG Study (CDIC-tDCS)
Primary Purpose
Impulsive Behavior
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Anodal tDCS
Sham tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Impulsive Behavior
Eligibility 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.
Sites / Locations
- University of Nottingham
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Anodal tDCS
Sham tDCS
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Total number of correct anti-saccade (AS) trials
A measure of rapid response impulsivity (inhibitory control)
Secondary Outcome Measures
Total number of correct pro-saccade (PS) trials
A behavioral measure of rapid response impulsivity (inhibitory control)
Saccade latency for anti-saccade (AS) trials
A behavioral measure of rapid response impulsivity (inhibitory control)
Saccade latency for pro-saccade (PS) trials
A behavioral measure of rapid response impulsivity (inhibitory control)
Total Scores on the UPPS+P Impulsive Behaviour Scale
A self-report measure of impulsivity
Alpha and Beta band activity
A Cortical measure of inhibitory control recorded using Magnetoencephalography (MEG). MEG is a brain imaging technique.
Full Information
NCT ID
NCT03484377
First Posted
March 14, 2018
Last Updated
February 24, 2020
Sponsor
Najat Khalifa
Collaborators
Medical Research Council, University of Nottingham
1. Study Identification
Unique Protocol Identification Number
NCT03484377
Brief Title
Cortical Dynamics of Inhibitory Control: A Concurrent tDCS-MEG Study
Acronym
CDIC-tDCS
Official Title
Measuring Cortical Dynamics of Inhibitory Control Before, During and After Transcranial Direct Current Stimulation (tDCS)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 15, 2018 (Actual)
Primary Completion Date
February 14, 2019 (Actual)
Study Completion Date
February 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Najat Khalifa
Collaborators
Medical Research Council, University of Nottingham
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impulsive Behavior
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Concurrent tDCS-MEG parallel arms single-blinded experimental design (right anodal v sham tDCS).
Masking
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
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anodal tDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Anodal tDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
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 Measure Information:
Title
Total number of correct anti-saccade (AS) trials
Description
A measure of rapid response impulsivity (inhibitory control)
Time Frame
Change from baseline after 20 minutes of tDCS
Secondary Outcome Measure Information:
Title
Total number of correct pro-saccade (PS) trials
Description
A behavioral measure of rapid response impulsivity (inhibitory control)
Time Frame
Change from baseline after 20 minutes of tDCS
Title
Saccade latency for anti-saccade (AS) trials
Description
A behavioral measure of rapid response impulsivity (inhibitory control)
Time Frame
Change from baseline after 20 minutes of tDCS
Title
Saccade latency for pro-saccade (PS) trials
Description
A behavioral measure of rapid response impulsivity (inhibitory control)
Time Frame
Change from baseline after 20 minutes of tDCS
Title
Total Scores on the UPPS+P Impulsive Behaviour Scale
Description
A self-report measure of impulsivity
Time Frame
Baseline
Title
Alpha and Beta band activity
Description
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 Pre-specified Outcome Measures:
Title
Alpha and Beta band activity
Description
Evaluation of mechanism of action of tDCS using MEG data
Time Frame
During 20 minutes of tDCS stimulation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Najat Khalifa, DM
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nottingham
City
Nottingham
State/Province
Notts
ZIP/Postal Code
NG7 2TU
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Cortical Dynamics of Inhibitory Control: A Concurrent tDCS-MEG Study
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