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TNS for Treating Nicotine Craving (TNS-nicotine)

S

Santa Casa Medical School

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Nicotine Craving

Treatments

Device: TRIGEMINAL NERVE STIMULATION (TNS)

Study type

Interventional

Funder types

Other

Identifiers

NCT02178852
TNS-nicotine

Details and patient eligibility

About

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.

Enrollment

22 estimated patients

Sex

All

Ages

18 to 69 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

22 participants in 2 patient groups, including a placebo group

TNS-active
Experimental group
Description:
TRIGEMINAL NERVE STIMULATION (TNS)
Treatment:
Device: TRIGEMINAL NERVE STIMULATION (TNS)
TNS-sham
Placebo Comparator group
Description:
TRIGEMINAL NERVE STIMULATION (TNS) - sham

Trial contacts and locations

1

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Central trial contact

Quirino Cordeiro, MD PhD; Pedro Shiozawa, MD

Data sourced from clinicaltrials.gov

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