Influence of tDCS on the Brain Activation Measured During the Decision Not to Smoke in High-risk Situations

NCT05875194 | Unknown

• 1 other identifier: 495/2021B02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Substance use disorders (SUD) are characterized by increased automatized responses to drug-related cues (cue-reactivity) and deficient cognitive control. Cue-reactivity (CR) can be elicited by internal (e.g. mood) or external (e.g. situations) cues closely related to consumption. Therefore, one aim for relapse prevention is to control CR by the enhancement of cognitive control, e.g., via noninvasive brain stimulation (NIBS) of cortical areas involved in inhibitory control. However, thus far, treatment effects of NIBS for relapse prevention in SUD are only moderate, despite clear neurophysiological targets. Critically, NIBS is commonly applied in highly standardized laboratory situation, not related to CR, neglecting the current individual (brain-) state. In the current study, relapse-relevant (brain-) states will be evoked in individual, naturalistic settings outside the laboratory and monitored by functional near-infrared spectroscopy (fNIRS; assessing cortical activation patterns) and heartrate variability (HRV; as a periphery physiological measure) to capture the optimal (cortical) state for subsequent NIBS by means of transcranial direct current stimulation (tDCS). The aim of this highly innovative approach is increasing the efficiency of relapse prevention in SUD. At its heart, multimodal measurements during real-world (substance-related) choices with high ecological validity will be used to identify markers for individual optimal target states for tDCS. In contrast to current approaches, the target brain state of the individual adaptively controls the tDCS to maximize therapeutic outcome. One obstacle is to clear the data from artefacts to interpret data at a single-trial level, which requires this proof-of-concept study. This data is prerequisite for further clinical randomized-controlled studies in patients with SUD.

Conditions

Tobacco Use Disorder

Keywords

cue-reactivity; smokers; fNIRS; naturalistic setting; dorsolateral prefrontal cortex (dlPFC); orbitofrontal cortex (OFC); transcranial direct current stimulation (tDCS); craving; heart-rate variability (HRV); galvanic skin response (GSR)

Outcome Measures

Primary Outcomes (7)

• Craving ratings

  verbally rated, scale from 0-100

  Measurement day 1

• Prefrontal fNIRS activity

  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)

  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)

  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)

  cross-correlation between dlPFC and OFC time series

  Measurement day 1

• Multimodal SVM craving classifiers

  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

  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 Outcomes (4)

• Relationship between trait impulsivity scores and subjective craving

  Measurement day 1

• Relationship between trait impulsivity scores and number of smoked cigarettes

  14 days

• Relationship between personality traits and state effects (self-efficacy, control beliefs) and craving

  Measurement day 1

• Relationship between anxiety and general preoccupation and number of smoked cigarettes

  14 days

Study Arms (2)

active transcranial direct current stimulation (tDCS)

EXPERIMENTAL

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

Device: active transcranial direct current stimulation (tDCS)

sham transcranial direct current stimulation (tDCS)

SHAM COMPARATOR

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

Device: active transcranial direct current stimulation (tDCS)

Interventions

active transcranial direct current stimulation (tDCS) DEVICE

2mA, over the left dlPFC (10-20 position F3), duration 15 minutes

Also known as: sham transcranial direct current stimulation (tDCS)

active transcranial direct current stimulation (tDCS); sham transcranial direct current stimulation (tDCS)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• informed consent
• daily cigarette consumption (already in the first half of the day)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• NIRX Medizintechnik GmbH, Gustav-Meyer Allee 25, 13355 Berlin: collaborator
• Hetzler Stiftung für Suchtforschung und Prävention: collaborator

Study Sites (1)

University Hospital for Psychiatry and Psychotherapy with Polyclinic

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Agnes Kroczek, Dr.

CONTACT

0049-7071-2987103; mailto:Agnes.Kroczek@med.uni-tuebingen.de

Ann-Christine Ehlis, Dr.

CONTACT

0049-7071-2987103; mailto:Ann-Christine.Ehlis@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A person, who is not involved in the study procedure will assign the participants to the sham or treatement condition. The study members will only receive for each stimulation a new number which is necessary to start and encode the type of stimulation (placebo or verum).
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: May 25, 2023
• Study Start: October 15, 2022
• Primary Completion: October 10, 2023
• Study Completion: December 15, 2023
• Last Updated: May 25, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)