Clinical trial NCT02178852: TNS for Treating Nicotine Craving
Official title: Effect of Trigeminal Nerve Stimulation (TNS) on Nicotine Craving: Phase II, Cross-over, Randomized, Sham-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Nicotine Craving
Lead sponsor: Santa Casa Medical School
Sponsor class: OTHER
First posted: 2014-07-01
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. patients over 18 years
2. both genres
3. diagnosed with nicotine related disorder for at least 12 months according to the diagnostic criteria of DSM-IV administered by a psychiatrist.
4. Also we will adopt as inclusion criteria a score of Nicotine Dependence Fagerstrom Test greater or equal to 5 points.
5. Finally, patients should be able to read and understand the portuguese language.
6. Patients will be selected from spontaneous demand. In accordance to informed consent -

Exclusion Criteria:

1. other psychiatric diagnosis such as bipolar Affective Disorder, alcohol dependence, schizophrenia and dementia.
2. 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.
3. 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.

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Primary outcomes:
measure: Craving for nicotine
timeFrame: (T1) Immediately before TNS protocol ; (T2) 30 minutes after TNS protocol
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Centro de Atencao Integrada à Saúde Mental - CAISM
state: SP
Study officials:
affiliation: Neuromodulation Laboratory - Santa Casa Medical School
name: Bruno Shiozawa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neuromodulation Laboratory - Santa Casa Medical School
name: Pedro Shiozawa, MD
role: STUDY_DIRECTOR
affiliation: Neuromodulation Laboratory - Santa Casa Medical School
name: Quirino Cordeiro, MD PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.