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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03484377
Other study ID # CiC2017051
Secondary ID 199-1801
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2018
Est. completion date February 28, 2019

Study information

Verified date February 2020
Source Nottinghamshire Healthcare NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date February 28, 2019
Est. primary completion date February 14, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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 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.

Locations

Country Name City State
United Kingdom University of Nottingham Nottingham Notts

Sponsors (3)

Lead Sponsor Collaborator
Najat Khalifa Medical Research Council, University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Alpha and Beta band activity Evaluation of mechanism of action of tDCS using MEG data During 20 minutes of tDCS stimulation
Primary Total number of correct anti-saccade (AS) trials A measure of rapid response impulsivity (inhibitory control) Change from baseline after 20 minutes of tDCS
Secondary Total number of correct pro-saccade (PS) trials A behavioral measure of rapid response impulsivity (inhibitory control) Change from baseline after 20 minutes of tDCS
Secondary Saccade latency for anti-saccade (AS) trials A behavioral measure of rapid response impulsivity (inhibitory control) Change from baseline after 20 minutes of tDCS
Secondary Saccade latency for pro-saccade (PS) trials A behavioral measure of rapid response impulsivity (inhibitory control) Change from baseline after 20 minutes of tDCS
Secondary Total Scores on the UPPS+P Impulsive Behaviour Scale A self-report measure of impulsivity Baseline
Secondary Alpha and Beta band activity A Cortical measure of inhibitory control recorded using Magnetoencephalography (MEG). MEG is a brain imaging technique. Change from baseline after 20 minutes of tDCS
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