- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05875194
Influence of tDCS on the Brain Activation Measured During the Decision Not to Smoke in High-risk Situations
Investigation of the Influence of Transcranial Direct Current Stimulation (tDCS) on the Brain Activation Measured by fNIRS During the Decision Not to Smoke in High-risk Situations
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Dependent smokers will be measured in the morning, adjusted to the usual time of getting up or a minimum 4-hour abstinence period. All participants will be measured on two days:
Day 1: First, after written consent to participate in the study, all inclusion and exclusion criteria are checked and standardized questionnaires are collected. To validate the activity in the dorsolateral prefrontal cortex (dlPFC) and in the orbitofrontal cortex (OFC) individually, two "localizer measurements" are performed. For the dlPFC, a go/nogo task will be used with smoke-associated and positive images; for the OFC, the same images from the dlPFC localizer will be used and viewed in a "passive viewing task" that will be pushed away by keypress.
Next, a modified version of a cue exposure follows for 5 min that has already been implemented in preliminary studies (Kroczek et al., 2016, 2017). All smokers have their own cigarettes, a lighter, and an ashtray on a table in front of them. The cue-exposure is done twice, once in a laboratory room and once in a naturalistic smoking setting. This condition is used as training for the Support Vector Machine (SVM).
This is followed by a cue exposure in which smokers are allowed to actually decide whether to smoke a cigarette or to resist. This condition occurs only outside, after the first part of the experiment has taken place. In this "50% condition", participants receive the instruction that they are allowed to take a drag on their cigarette after each prompt and they should take a drag in about half of the trials. Smoking behavior (puff on the cigarette/no puff on the cigarette) and also craving is noted by the experimenter.The goal of the first day is to train the SVM to detect maximum cue-reactivity concurrent to its cognitive control by response inhibition
Day 2: At most one week after time point 1, the SVM will be used to promote the cortical activity state that enables effective cue exposure therapy during the exposure condition in the smoking risk situation. With the aid of SVM, a tDCS intervention should be triggered at the optimal moment to further solidify extinction learning. This cue exposure measurement is used to classify successful inhibition of smoking. The measurement will take place in the naturalistic setting outside and the participants are NOT allowed to smoke but should increase their craving. As soon as the desired activity state is reached, indicated by the SVM, but at the latest after 5 minutes, tDCS is applied.
At the end of the experiment, the subjects will receive an information sheet on the consequences of smoking and information on the services offered by the Smoking Cessation Working Group at the University Hospital of Tübingen. In addition, the participants are psychoeducated that any exposure during the decision not to smoke helps to weaken the addiction memory. Information is provided that accordingly the follow-up survey on the cell phone will also record whether there were situations in which the smokers did not give in to craving in everyday life. This daily query is to take place in the evening over a period of 2 weeks by means of "Ecological Momentary Assessment" (EMA) on the smoker's own cell phone. EMA will be used to assess smoking behavior and potential situations on the current day in which the desire to smoke was triggered without giving in to this desire.
Total time expenditure for the participants will be approximately 3.5 hours, for which they will receive an expense allowance of 10€/hour.
All measurements will take place at the Department of Psychiatry and Psychotherapy of the University Hospital Tübingen in the Laboratory of Psycho-physiology and Optical Imaging (room U81, Osianderstr. 24, 72076 Tübingen) or on a bench close to the hospital.
Sample size:
The sample size is based on a preliminary study by the working group investigating cue exposure and tDCS interventions (Kroczek et al., 2017) with an effect size of d=0.66. Calculating the sample size in a within-subject design, with an alpha of 0.05 and a beta of 0.90 results in a required N of 28. Since the methodology differs from the previous experimental procedure by leaving the laboratory (with additional sources of interference by daylight and movement), additional participants shall be collected to a total sample of N=60.
Demographic data and questionnaires:
Participants' demographic data and information on current medication and handedness (Edinburgh Handedness Inventory (EHI)) will be collected in addition to smoking-related questionnaires including the FTND and Questionnaire on Smoking Urges (QSU-b). Smoking-related self-efficacy and abstinence motivation will also be assessed, in addition to the Positive and Negative Affect Schedule (PANAS), depressed mood (via the BDI-II), the State-Trait Anxiety Inventory, the level of general worry (via the WDQ), impulsivity (BIS-15,UPPS), general self-efficacy (via the SWE) and control beliefs (IE4).
A written follow-up survey about the tDCS will also be conducted to allow for a blinding check.
In addition, visual analog scales for the questions "how strong is your desire to smoke a cigarette" and "how strong is your stress experience" will be completed before and after each measurement.
Hypotheses:
The primary study goal is to quantify context effects. Here, we will examine the influence of context on different levels of cue reactivity.
The second primary study objective is to demonstrate the feasibility of SVM for identifying extinction processes and the feasibility that this SVM-based trigger can be used for tDCS. And lastly, we test the hypothesis that tDCS will have an impact on smoking behavior two weeks after the study.
Another secondary study objective concerns individual factors in the prediction of cue reactivity, immediate smoking in the 50:50 condition and number of smoked cigarettes within 14 days after tDCS.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Agnes Kroczek, Dr.
- Phone Number: 0049-7071-2987103
- Email: mailto:Agnes.Kroczek@med.uni-tuebingen.de
Study Contact Backup
- Name: Ann-Christine Ehlis, Dr.
- Phone Number: 0049-7071-2987103
- Email: mailto:Ann-Christine.Ehlis@med.uni-tuebingen.de
Study Locations
-
-
Baden-Württemberg
-
Tübingen, Baden-Württemberg, Germany, 72076
- Recruiting
- University Hospital for Psychiatry and Psychotherapy with Polyclinic
-
Contact:
- Andreas Fallgatter, Prof. Dr.
- Phone Number: 0049-7071-84858
- Email: Prof. Dr. Andreas Fallgatter <Andreas.Fallgatter@med.uni-tuebingen.de>
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- informed consent
- daily cigarette consumption (already in the first half of the day)
Exclusion Criteria:
Acute or chronic disease (also anamnestic) that may affect brain metabolism:
- pre-existing diabetes mellitus (E10-E14) according to ICD-10
- Renal insufficiency from stage 3 of the Kidney Disease Outcomes Quality Initiative onwards
- Uncontrolled hypertension (I10.x according to ICD-10)
- Moderate or severe traumatic brain injury (GCS 3-12) or 2nd- or 3rd-degree traumatic brain injury with loss of consciousness > 30 min
- Epilepsy (personal or in first-degree relatives).
- Currently present psychiatric or neurological disease
- Regular use of medications that affect blood flow (e.g., ASA).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: active transcranial direct current stimulation (tDCS)
A single application of transcranial direct current stimulation (tDCS), anodal stimulation of the left dlPFC placed (10-20 position F3) and the reference electrode on the arm, intensity 2mA, with retangular electrodes, size 35cm2, current intensity is ramped up to 2mA over a period of 20 seconds, duration 15 minutes
|
2mA, over the left dlPFC (10-20 position F3), duration 15 minutes
Other Names:
|
Sham Comparator: sham transcranial direct current stimulation (tDCS)
A single application of transcranial direct sham stimulation (tDCS), with sponge electrodes, placed over left dlPFC (10-20 position F3) and the reference electrode on the arm, with retangular electrodes 35cm2,intensity is ramped up to 2mA over a period of 20 seconds duration and then switched off again at the end of 20 s ramp.
To ensure that there are no differences in perception, this is applied in both verum and sham stimulation, duration 15 min
|
2mA, over the left dlPFC (10-20 position F3), duration 15 minutes
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Craving ratings
Time Frame: Measurement day 1
|
verbally rated, scale from 0-100
|
Measurement day 1
|
Prefrontal fNIRS activity
Time Frame: Measurement day 1
|
Concentration changes of oxygenated (O2Hb) and deoxygenated (Hhb) hemoglobin in prefrontal regions of interest (dlPFC, OFC)
|
Measurement day 1
|
Activity of the sympathetic nervous system (SNS)
Time Frame: Measurement day 1
|
Galvanic skin response (GSR) regarding total peaks, amplitudes of peak (microsiemens) and frequency power of GSR as measures
|
Measurement day 1
|
Activity of the parasympathetic nervous system (PNS): Heart-rate variability (HRV)
Time Frame: Measurement day 1
|
Heart-rate Variabilty (HRV) indexes related to the PNS: RMSSD, pNN50 (in %), HF (in ms2).
|
Measurement day 1
|
Functional connectivity of dlPFC and OFC (fNIRS data)
Time Frame: Measurement day 1
|
cross-correlation between dlPFC and OFC time series
|
Measurement day 1
|
Multimodal SVM craving classifiers
Time Frame: Measurement day 1
|
The 5-dimensional training vectors (consisting of OFC activity, dlPFC activity, OFC-dlPFC connectivity, GSR, HRV) will be manually assigned a value between -1 and 1 based on the subjective craving ratings.
The prediction of the SVM classifier will be tested in the 50:50 condition and related to smoking probability.
|
Measurement day 1
|
Efficacy of extinction learning
Time Frame: 14 days after measurement day 2
|
Assessment of the amount of self-reported smoked cigarettes and subjective craving (0-100) in a 2-week follow-up period (EMA)
|
14 days after measurement day 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relationship between trait impulsivity scores and subjective craving
Time Frame: Measurement day 1
|
Pearson correlation
|
Measurement day 1
|
Relationship between trait impulsivity scores and number of smoked cigarettes
Time Frame: 14 days
|
Pearson correlation (EMA questionnaires)
|
14 days
|
Relationship between personality traits and state effects (self-efficacy, control beliefs) and craving
Time Frame: Measurement day 1
|
Pearson correlation of state and trait anxiety, WDQ, SER, IE-4 scores and subjective craving
|
Measurement day 1
|
Relationship between anxiety and general preoccupation and number of smoked cigarettes
Time Frame: 14 days
|
Pearson correlation of state and trait anxiety, WDQ, number of smoked cigarettes (EMA questionnaires)
|
14 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 495/2021B02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Tobacco Use Disorder
-
Washington University School of MedicineNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Nicotine Dependence | Tobacco Dependence | Smoking, Tobacco | Nicotine Use Disorder | Nicotine Dependence, Cigarettes | Smoking, Cigarette | Nicotine Dependence Tobacco Product | Tobacco; Use, Rehabilitation | Smoking (Tobacco) Addiction and other conditionsUnited States
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)RecruitingTobacco Use | Tobacco Smoking | Tobacco Use Disorder | Tobacco Use Cessation | Tobacco DependenceUnited States
-
Harvard School of Public Health (HSPH)Beacon Communities; The Community BuildersEnrolling by invitationTobacco Use | Tobacco Smoking | Tobacco Use Disorder | Tobacco Use Cessation | Second Hand Tobacco SmokeUnited States
-
University of California, San FranciscoNational Institute on Minority Health and Health Disparities (NIMHD)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Disorder | Tobacco Use Cessation | Tobacco Dependence | Smoking, Tobacco | Smoking, CigaretteUnited States
-
University of California, San FranciscoTobacco Related Disease Research ProgramCompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Disorder | Tobacco Use Cessation | Tobacco Dependence | Smoking, Tobacco | Smoking, CigaretteUnited States
-
New York State Psychiatric InstituteTerminatedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Disorder | Nicotine Dependence | Cigarette Smoking | Tobacco Dependence | Nicotine Use Disorder | Smoking, CigaretteUnited States
-
Rutgers, The State University of New JerseyNational Institute on Drug Abuse (NIDA)CompletedSchizophrenia | Schizoaffective Disorder | Tobacco Use | Tobacco Smoking | Tobacco Use Disorder | Tobacco Use CessationUnited States
-
University of PennsylvaniaFood and Drug Administration (FDA)Completed
-
University of Kansas Medical CenterCompletedTobacco Use Disorder/Cigarette SmokingUnited States
-
Ottawa Hospital Research InstituteCompletedTobacco Use Disorder | Tobacco Use Cessation | Tobacco Dependence
Clinical Trials on active transcranial direct current stimulation (tDCS)
-
Manhattan Psychiatric CenterCompletedSchizophrenia | Auditory HallucinationUnited States
-
D'Or Institute for Research and EducationCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Conselho Nacional... and other collaboratorsCompleted
-
Centre Hospitalier St AnneNot yet recruiting
-
ElsanRecruitingCancer Pain | Refractory PainFrance
-
VA Office of Research and DevelopmentRecruitingSuicide | ImpulsivityUnited States
-
VA Office of Research and DevelopmentRecruitingObesityUnited States
-
Minneapolis Veterans Affairs Medical CenterRecruitingAlzheimer Disease | Mild Cognitive ImpairmentUnited States
-
Hebrew SeniorLifeNational Institute on Aging (NIA)Not yet recruitingFall | Mobility Limitation | Gait, UnsteadyUnited States
-
Minneapolis Veterans Affairs Medical CenterThe Defense and Veterans Brain Injury Center; Center for Veterans Research... and other collaboratorsActive, not recruitingTraumatic Brain Injury | ImpulsivityUnited States
-
United States Army Aeromedical Research LaboratoryCompletedTranscranial Direct Current StimulationUnited States