TNS for Treating Nicotine Craving

Phase 1

• Conditions: Nicotine Craving
• Interventions: Device: TRIGEMINAL NERVE STIMULATION (TNS)

• Registration Number: NCT02178852
• Lead Sponsor: Santa Casa Medical School

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-06
• Study First Submitted: 2014-06-26
• Study First Submitted QC: 2014-06-27
• Last Update Submitted: 2014-06-27
• Study First Posted: 2014-07-01
• Last Update Posted: 2014-07-01
• Study Start: 2014-08
• Primary Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TNS-active	TRIGEMINAL NERVE STIMULATION (TNS)	TRIGEMINAL NERVE STIMULATION (TNS)

Primary Outcome Measures

Name	Time	Method
Craving for nicotine	(T1) Immediately before TNS protocol ; (T2) 30 minutes after TNS protocol	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.

Trial Locations

Locations (1)

Centro de Atencao Integrada à Saúde Mental - CAISM; 🇧🇷 Sao Paulo, SP, Brazil