Effects of Repetitive tDCS on ad Libitum Smoking Behavior: EMA and EEG Study

November 15, 2018 updated by: Ingmar Franken, Erasmus Medical Center

Effects of Repetitive tDCS on ad Libitum Smoking Behavior: An EMA and EEG Study

Bilateral (left cathodal/ right anodal) transcranial Direct Current Stimulation (tDCS) over the dorsolateral prefrontal cortex (DLPFC) seems to reduce craving and to increase the time till smoking the first cigarette after the intervention. The current study explores whether actual cigarette consumption decreases after repetitive tDCS. Cigarette consumption and craving will therefore be measured by means of EMA, before (at baseline), during and after multiple tDCS sessions, and at 3 months follow-up.

To study the working mechanism behind the effects of tDCS, electrophysiological responses (ERPs) and behavioral measures of cognitive control functioning will be taken into account at baseline, one day after the last tDCS session and at three months follow up.

We hypothesize that cigarette consumption will decrease after repetitive tDCS, and that this effect is associated with better cognitive control functioning.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The proposed experiment is a double-blind randomized placebo-controlled trial. 60 smokers will be randomly assigned to two conditions, namely tDCS or sham (placebo).

Participants will receive real tDCS or sham for three days in one week. The interventions contain twice daily sessions for 13 minutes with an interval of 20 min. Moreover, on the first treatment day and the day after the treatment week, participants complete a number of questionnaires, and perform two psychological tasks (a gambling task and the Go/NoGo task) to measure cognitive control functioning (e.g. risky decision making and inhibitory control respectively). During these tasks, event-related potentials will be recorded by means of EEG. After three months, participants are asked to return to fill out the same questionnaires and perform the same psychological tasks as before, to measure the lasting effect of tDCS. During this last session, event-related potentials will also be recorded. In addition, carbon monoxide levels will be measured on all days where subjects perform the tasks.

EMA:

For three weeks, starting the week before tDCS treatment, participants are asked to log every cigarette before they smoke one. During these weeks, participants complete EMA questionnaires on their mobile phone about cigarette consumption, craving, and affect that will take approximately 5 minutes. The EMA questionnaire will be presented four times daily on a quasi-random basis. Finally, during end-of-day assessments participants have the possibility to indicate any missed cigarettes. At three months follow-up, participants are asked to undergo the same EMA procedure for one more week, to study the lasting effects of tDCS.

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3000 DR
        • Erasmus University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Currently smoking 10 or more cigarettes a day
  • The ability to speak, read, and write in Dutch at an eight-grade literacy level

Exclusion Criteria:

  • The current abuse of a substance other than nicotine or caffeine
  • History of neurological or psychiatric disorders
  • Any contraindication for electrical brain stimulation procedures such as electronic implants or metal implants
  • Pregnancy or breast-feeding
  • In the process of quitting smoking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Real transcranial Direct Current Stimulation
This group will receive bilateral tDCS (left cathodal/right anodal) over the DLPFC. The stimulation will take place two times daily for 13 minutes with a rest interval of 20 minutes for three days in one week.
Device: tDCS
tDCS is an electrical brain stimulation method
Other Names:
  • transcranial direct current stimulation
SHAM_COMPARATOR: Sham tDCS
The control group receives sham, for which the stimulator will be gradually turned off after 30 seconds.
Device: tDCS
tDCS is an electrical brain stimulation method
Other Names:
  • transcranial direct current stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean number of cigarettes a day at 3 months follow up
Time Frame: 3 months
The mean number of cigarettes will be measured at three months follow-up by means of Ecological Momentary Assessments (EMA). This means that participants are asked to report every cigarette they smoke at the moment they're about to smoke it with an app on their mobile phone. Participants do this during the week before the last EEG session at three months follow-up.The mean number will be calculated over this week
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean number of cigarettes a day one week after tDCS
Time Frame: 1 week
The mean number of cigarettes will be measured at one week after the last tDCS session by means of Ecological Momentary Assessments (EMA). This means that participants are asked to report every cigarette they smoke at the moment they're about to smoke it with an app on their mobile phone. Participants do this for one week starting from the last tDCS session. The mean number will be calculated over this week
1 week
Craving at 3 months follow-up
Time Frame: 3 months
Participants receive 4 prompts a day in the app on the smartphone to fill out questions about craving for 1 week starting the week before the last EEG session at three months follow-up
3 months
Affect 3 months after tDCS
Time Frame: 3 months
Participants receive 4 prompts a day in the app on the smartphone to fill out questions about affect for 1 week starting the week before the last EEG session at three months follow-up
3 months
Craving one week after tDCS
Time Frame: 1 week
Participants receive 4 prompts a day in the app on the smartphone to fill out questions about craving for 1 week starting the day after the last tDCS session
1 week
Affect one week after tDCS
Time Frame: 1 week
Participants receive 4 prompts a day in the app on the smartphone to fill out questions about affect for 1 week starting the day after the last tDCS session
1 week
Behavioral responses of risk-taking
Time Frame: 3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
Measured with the two-choice gambling task: proportion of high-risk (higher values) choices
3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
Behavioral responses of inhibitory control
Time Frame: 3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
Measured by proportion correctly inhibited NoGo trials on the Go/NoGo task
3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
Feedback Related Negativity (FRN): Event Related potential (ERP) of reward processing
Time Frame: 3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
Measured with the two choice gambling task. After the choice (high/low risk) is made, participants receive feedback (either they lose or win). The Feedback Related Negativity (FRN) will be measured after feedback by means of EEG.
3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
Reward related P300: Event related potential (ERP) of reward processing
Time Frame: 3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
Measured with the two choice gambling task. After the choice (high/low risk) is made, participants receive feedback (either they lose or win). The reward related P300 will be measured 300-500 ms after feedback by means of EEG.
3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
N200: Event related potential (ERP) of inhibitory control
Time Frame: 3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
The N200 will be measured after NoGo trials in the Go/NoGo task
3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
P300: Event related potential (ERP) of inhibitory control
Time Frame: 3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
The P300 will be measured after NoGo trials in the Go/NoGo task
3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
Error related negativity: Event related potential (ERP) of error processing
Time Frame: 3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
Wrong responses to Go and NoGo trials in the Go/NoGo task will be used to assess the error related negativity (ERN)
3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up
Course of cigarette consumption
Time Frame: 2 weeks
Number of cigarettes (and craving) a day starting on the first tDCS day until one week after the last tDCS intervention
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2016

Primary Completion (ACTUAL)

March 1, 2018

Study Completion (ACTUAL)

July 1, 2018

Study Registration Dates

First Submitted

January 5, 2017

First Submitted That Met QC Criteria

January 19, 2017

First Posted (ESTIMATE)

January 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 16, 2018

Last Update Submitted That Met QC Criteria

November 15, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL58190.078.16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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