NCT02178852

TNS for Treating Nicotine Craving

Effect of Trigeminal Nerve Stimulation (TNS) on Nicotine Craving: Phase II, Cross-over, Randomized, Sham-controlled Clinical Trial

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Santa Casa Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nicotine Craving

Interventions

Type	Name	Description
DEVICE	TRIGEMINAL NERVE STIMULATION (TNS)	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

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-08-01
• First posted: 2014-07-01
• Last updated: 2014-07-01

Locations

1 site across 1 country: Brazil