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Cortical Excitability and Role of rTMS in Nicotine Use Disorder

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ClinicalTrials.gov Identifier: NCT03264755
Recruitment Status : Not yet recruiting
First Posted : August 29, 2017
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Amira Moheb, Assiut University

Brief Summary:
Cortical excitability and role of repetitive transcranial magnetic stimulation in nicotine use disorder. Estimation of cortical excitability in heavy smoker patients and determination of role of repetitive transcranial magnetic stimulation for reducing nicotine craving.

Condition or disease Intervention/treatment Phase
Nicotine Use Disorder Device: Repetitive transcranial magnetic stimulation Not Applicable

Detailed Description:

Nicotine is one of the main components of cigarettes and affects the central nervous system mainly via nicotinic acetylcholine receptors. It has further effects on neuromodulation by regulating the release of dopamine, serotonin, glutamate and adrenaline. In studies, it has been shown that nicotine improves attention and working memory in animals and humans, while nicotine withdrawal leads to reduced working and verbal memory capacity in otherwise healthy tobacco smokers. In schizophrenics and patients suffering from attention deficit hyperactivity disorder, nicotine improves cognitive performance. A likely basis of the nicotinic effects on cognitive functions is its effect on cortical excitability and activity. Here, neurophysiological studies mainly base on animal experiments and have shown in vitro that the nicotinic acetylcholine receptors elicit neuronal depolarisation by inducing transmembrane cationic inward currents (Calcium), thus being involved in induction and modulation of neuroplasticity and cortical excitability.

Repetitive transcranial magnetic stimulation: is a non-invasive brain stimulation technique that has shown positive results in the treatment of depression, schizophrenia, and more recently addiction. Repetitive transcranial magnetic stimulation uses alternating magnetic fields to induce electric currents in the cortical tissue. Low-frequency as one hertz repetitive transcranial magnetic stimulation is believed to inhibit neuronal firing in a localized area and is used to induce virtual brain lesions. High-frequency as more than three hertz repetitive transcranial magnetic stimulation is believed to be excitatory in nature and can result in neuronal depolarization under the stimulating coil. However, the effects of repetitive transcranial magnetic stimulation are not limited to the site of stimulation and can induce changes in distant interconnected sites of the brain, and consequently may influence subcortical regions.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cortical Excitability and Role of rTMS in Nicotine Use Disorder
Estimated Study Start Date : January 4, 2019
Estimated Primary Completion Date : December 4, 2019
Estimated Study Completion Date : December 4, 2020

Arm Intervention/treatment
Active Comparator: cortical excitability in smokers Device: Repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation for cortical excitability in smokers and non smokers

Active Comparator: cortical excitability in nonsmokers Device: Repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation for cortical excitability in smokers and non smokers




Primary Outcome Measures :
  1. Comparison of cortical excitability between smoker and non smoker [ Time Frame: 24 month ]
    Comparison of cortical excitability between smoker and non smoker :The primary motor cortex served as model, and cortical excitability was monitored via transcranial magnetic stimulation (TMS).



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   18 years
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

1 )patients must be 18 to 50 years of age. 2) heavy smokers (daily cigarettes consumption of more than 20 pieces.)

Exclusion Criteria:

  1. cardiac pacemaker.
  2. metal implants in the head.
  3. Renal diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03264755


Contacts
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Contact: Ahmed Abdel Bakay, Assistant prof 01096477803 ahmedbaki2020@yahoo.com

Sponsors and Collaborators
Assiut University

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Responsible Party: Amira Moheb, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03264755     History of Changes
Other Study ID Numbers: CEARORINUD
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Tobacco Use Disorder
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action