Last reviewed · How we verify
NCT05875194
Influence of tDCS on the Brain Activation Measured During the Decision Not to Smoke in High-risk Situations
NA trial testing active transcranial direct current stimulation (tDCS) in Tobacco Use Disorder in 60 participants. Status unknown.
10 October 2023
Quick facts
| Lead sponsor | University Hospital Tuebingen |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | basic science |
| Enrollment | 60 |
| Start date | 15 October 2022 |
| Primary completion | 10 October 2023 |
| Estimated completion | 15 December 2023 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- active transcranial direct current stimulation (tDCS)
Conditions studied
- Tobacco Use Disorder — all drugs for Tobacco Use Disorder →
Sponsor
University Hospital Tuebingen
Who can join
Adults 18 to 70, any sex, with Tobacco Use Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05875194
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of active transcranial direct current stimulation (tDCS)
Trials testing the same drug.
- NCT07128602 — Determining the Effects of Non-invasive Brain Stimulation to Improve Quadriceps Muscle Function After ACL Reconstruction · Phase 1, PHASE2 · recruiting
- NCT04422886 — Does Physiotherapy Plus Non-invasive Brain Stimulation Improve Motor Recovery in Children With Acquired Brain Injury? · NA · terminated
Other recruiting trials for Tobacco Use Disorder
Currently open trials in the same condition.
- NCT07466875 — Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients · NA · recruiting
- NCT06678672 — Contingency Management for Veteran Smokers Undergoing Major Elective Surgery · NA · recruiting
- NCT06006143 — Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 2 · Phase 2 · active not recruiting
- NCT06883162 — Cannabis-Tobacco Co-Use Treatment Study · Phase 3 · recruiting
- NCT06798324 — tDCS Plus Varenicline for Smoking Cessation · Phase 4 · recruiting
Other University Hospital Tuebingen trials
Trials by the same sponsor.
- NCT07378670 — DEfeating PEnile CAncer-2 · NA · recruiting
- NCT07276503 — Verification of a New Predictive Delirium Score in Adults With Elective Cardiac Valve or Bypass Surgery With Perioperati · not yet recruiting
- NCT07411365 — Dual-task Cognitive-motor Telerehabilitation in Persons With PD-MCI · NA · not yet recruiting
- NCT06953791 — Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Prednisolone or aCDED With PEN in Adult Pat · Phase 2 · recruiting
- NCT07378891 — Artificial-Intelligence-based Early Detection of Diabetic Retinopathy (FUNDUS AI) · enrolling by invitation
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05875194 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital Tuebingen
- Last refreshed: 25 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05875194.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing