Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Electrical stimulation provides direct modulatory effects on subcortical regions. Indeed, neuroimaging studies show changes in neural activity in specific brain regions such as the amygdala, insula, precentral gyrus, hippocampus and thalamus. The neuroanatomical connections established with the trigeminal nerve have been associated with the mechanism called "bottom-up" neuromodulation. According to this hypothesis, the spread of electrical stimulation follows a path from the peripheral nerves towards the brain stem was then advertise for cortical and subcortical regions. Connections to structures involved in the reward system as the amygdala and hippocampus could theoretically modulate dysfunctional brain activity in these regions, which may induce favorable clinical effects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TNS-active | Experimental | TRIGEMINAL NERVE STIMULATION (TNS) |
|
| TNS-sham | Placebo Comparator | TRIGEMINAL NERVE STIMULATION (TNS) - sham |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRIGEMINAL NERVE STIMULATION (TNS) | Device | TNS stimulation over V1 branches of V cranial nerve. Single session for 30 minutes. The patient will undergo a specific cue-induced cigarette craving model during the final 3 minutes of stimulation. Craving scores will be rated before and after stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Craving for nicotine | Craving for nicotine assessed by visual scale before and after cue-induced images for nicotine craving. Patients will be exposed to visual model for cue-induced images related to nicotine craving during the last 3 minutes of the TNS protocol (which has an overall time of 30 minutes). Main comparison will be between T1 and T2 craving level. | (T1) Immediately before TNS protocol ; (T2) 30 minutes after TNS protocol |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
other psychiatric diagnosis such as bipolar Affective Disorder, alcohol dependence, schizophrenia and dementia.
Also excluded patients with severe neurological or medical diseases, such as neurodegenerative diseases, stroke, cancer in activity, congestive heart failure or chronic obstructive pulmonary disease stage III or IV.
Finally, patients with severe suicidal ideation (structured planning suicide or attempted suicide in the past 4 weeks) will be excluded. In this case, the patient will be seen immediately by a psychiatrist of the research itself that will take the appropriate clinical management according to the severity of suicidal thinking.
-
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pedro Shiozawa, MD | Contact | 551134662105 | pedroshiozawa@gmail.com | |
| Quirino Cordeiro, MD PhD | Contact | 551134662100 | qcordeiro@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Bruno Shiozawa, MD | Neuromodulation Laboratory - Santa Casa Medical School | Principal Investigator |
| Pedro Shiozawa, MD | Neuromodulation Laboratory - Santa Casa Medical School | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Atencao Integrada à Saúde Mental - CAISM | São Paulo | São Paulo | 04017030 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24814566 | Background | Fecteau S, Agosta S, Hone-Blanchet A, Fregni F, Boggio P, Ciraulo D, Pascual-Leone A. Modulation of smoking and decision-making behaviors with transcranial direct current stimulation in tobacco smokers: a preliminary study. Drug Alcohol Depend. 2014 Jul 1;140:78-84. doi: 10.1016/j.drugalcdep.2014.03.036. Epub 2014 Apr 16. | |
| 24242143 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Quirino Cordeiro, MD PhD | Neuromodulation Laboratory - Santa Casa Medical School | Study Chair |
| Luigjes J, Breteler R, Vanneste S, de Ridder D. [Neuromodulation as an intervention for addiction: overview and future prospects]. Tijdschr Psychiatr. 2013;55(11):841-52. Dutch. |
| 24154668 | Background | Pedron S, Monnin J, Haffen E, Sechter D, Van Waes V. Repeated transcranial direct current stimulation prevents abnormal behaviors associated with abstinence from chronic nicotine consumption. Neuropsychopharmacology. 2014 Mar;39(4):981-8. doi: 10.1038/npp.2013.298. Epub 2013 Oct 24. |
| 24065930 | Background | Xu J, Fregni F, Brody AL, Rahman AS. Transcranial direct current stimulation reduces negative affect but not cigarette craving in overnight abstinent smokers. Front Psychiatry. 2013 Sep 20;4:112. doi: 10.3389/fpsyt.2013.00112. eCollection 2013. |
| 23133419 | Background | Grundey J, Thirugnanasambandam N, Kaminsky K, Drees A, Skwirba AC, Lang N, Paulus W, Nitsche MA. Rapid effect of nicotine intake on neuroplasticity in non-smoking humans. Front Pharmacol. 2012 Oct 26;3:186. doi: 10.3389/fphar.2012.00186. eCollection 2012. |