NCT03484377

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

September 15, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2019

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

5 months

First QC Date

March 14, 2018

Last Update Submit

February 24, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Total number of correct pro-saccade (PS) trials

    Change from baseline after 20 minutes of tDCS

  • Saccade latency for anti-saccade (AS) trials

    Change from baseline after 20 minutes of tDCS

  • Saccade latency for pro-saccade (PS) trials

    Change from baseline after 20 minutes of tDCS

  • Total Scores on the UPPS+P Impulsive Behaviour Scale

    Baseline

  • Alpha and Beta band activity

    Change from baseline after 20 minutes of tDCS

Other Outcomes (1)

  • Alpha and Beta band activity

    During 20 minutes of tDCS stimulation

Study Arms (2)

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.

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.

Device: Sham tDCS

Interventions

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.

Anodal tDCS
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.

Sham tDCS

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • University students and staff
  • Aged 18-40

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nottingham

Nottingham, Notts, NG7 2TU, United Kingdom

Location

MeSH Terms

Conditions

Impulsive Behavior

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Najat Khalifa, DM

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Concurrent tDCS-MEG parallel arms single-blinded experimental design (right anodal v sham tDCS).
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 14, 2018

First Posted

March 30, 2018

Study Start

September 15, 2018

Primary Completion

February 14, 2019

Study Completion

February 28, 2019

Last Updated

February 25, 2020

Record last verified: 2020-02

Locations