TNS for Treating Nicotine Craving

NCT02178852 | Unknown Phase 1

• 1 other identifier: TNS-nicotine
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Craving

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

TNS-active

EXPERIMENTAL

TRIGEMINAL NERVE STIMULATION (TNS)

Device: TRIGEMINAL NERVE STIMULATION (TNS)

TNS-sham

PLACEBO COMPARATOR

TRIGEMINAL NERVE STIMULATION (TNS) - sham

Interventions

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

Also known as: TNS

TNS-active

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients over 18 years
• both genres
• diagnosed with nicotine related disorder for at least 12 months according to the diagnostic criteria of DSM-IV administered by a psychiatrist.
• Finally, patients should be able to read and understand the portuguese language.
• Patients will be selected from spontaneous demand. In accordance to informed consent -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Santa Casa Medical School: lead

Study Sites (1)

Centro de Atencao Integrada à Saúde Mental - CAISM

São Paulo, São Paulo, 04017030, Brazil

Location

Related Publications (5)

• 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.

  PMID: 24814566 BACKGROUND

• 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.

  PMID: 24242143 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.

  PMID: 24154668 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.

  PMID: 24065930 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.

  PMID: 23133419 BACKGROUND

Study Officials

• Bruno Shiozawa, MD

  Neuromodulation Laboratory - Santa Casa Medical School

  PRINCIPAL INVESTIGATOR

• Pedro Shiozawa, MD

  Neuromodulation Laboratory - Santa Casa Medical School

  STUDY DIRECTOR

• Quirino Cordeiro, MD PhD

  Neuromodulation Laboratory - Santa Casa Medical School

  STUDY CHAIR

Central Study Contacts

Pedro Shiozawa, MD

CONTACT

551134662105; pedroshiozawa@gmail.com

Quirino Cordeiro, MD PhD

CONTACT

551134662100; qcordeiro@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator Neuromodulation Laboratory

Study Record Dates

• First Submitted: June 26, 2014
• First Posted: July 1, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2015
• Last Updated: July 1, 2014

Record last verified: 2014-06

Locations

BR (1)