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

NCT05875194 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-05-25

No results posted yet for this study

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

Interventions

DEVICE

active transcranial direct current stimulation (tDCS)

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

Sponsors & Collaborators

  • NIRX Medizintechnik GmbH, Gustav-Meyer Allee 25, 13355 Berlin

    collaborator UNKNOWN

  • Hetzler Stiftung für Suchtforschung und Prävention

    collaborator UNKNOWN

  • University Hospital Tuebingen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-15
Primary Completion
2023-10-10
Completion
2023-12-15

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05875194 on ClinicalTrials.gov