<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03264755</url>
  </required_header>
  <id_info>
    <org_study_id>CEARORINUD</org_study_id>
    <nct_id>NCT03264755</nct_id>
  </id_info>
  <brief_title>Cortical Excitability and Role of rTMS in Nicotine Use Disorder</brief_title>
  <official_title>Cortical Excitability and Role of rTMS in Nicotine Use Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cortical excitability and role of repetitive transcranial magnetic stimulation in nicotine&#xD;
      use disorder. Estimation of cortical excitability in heavy smoker patients and determination&#xD;
      of role of repetitive transcranial magnetic stimulation for reducing nicotine craving.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nicotine is one of the main components of cigarettes and affects the central nervous system&#xD;
      mainly via nicotinic acetylcholine receptors. It has further effects on neuromodulation by&#xD;
      regulating the release of dopamine, serotonin, glutamate and adrenaline. In studies, it has&#xD;
      been shown that nicotine improves attention and working memory in animals and humans, while&#xD;
      nicotine withdrawal leads to reduced working and verbal memory capacity in otherwise healthy&#xD;
      tobacco smokers. In schizophrenics and patients suffering from attention deficit&#xD;
      hyperactivity disorder, nicotine improves cognitive performance. A likely basis of the&#xD;
      nicotinic effects on cognitive functions is its effect on cortical excitability and activity.&#xD;
      Here, neurophysiological studies mainly base on animal experiments and have shown in vitro&#xD;
      that the nicotinic acetylcholine receptors elicit neuronal depolarisation by inducing&#xD;
      transmembrane cationic inward currents (Calcium), thus being involved in induction and&#xD;
      modulation of neuroplasticity and cortical excitability.&#xD;
&#xD;
      Repetitive transcranial magnetic stimulation: is a non-invasive brain stimulation technique&#xD;
      that has shown positive results in the treatment of depression, schizophrenia, and more&#xD;
      recently addiction. Repetitive transcranial magnetic stimulation uses alternating magnetic&#xD;
      fields to induce electric currents in the cortical tissue. Low-frequency as one hertz&#xD;
      repetitive transcranial magnetic stimulation is believed to inhibit neuronal firing in a&#xD;
      localized area and is used to induce virtual brain lesions. High-frequency as more than three&#xD;
      hertz repetitive transcranial magnetic stimulation is believed to be excitatory in nature and&#xD;
      can result in neuronal depolarization under the stimulating coil. However, the effects of&#xD;
      repetitive transcranial magnetic stimulation are not limited to the site of stimulation and&#xD;
      can induce changes in distant interconnected sites of the brain, and consequently may&#xD;
      influence subcortical regions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">May 4, 2020</start_date>
  <completion_date type="Anticipated">December 4, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 4, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of cortical excitability between smoker and non smoker</measure>
    <time_frame>24 month</time_frame>
    <description>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).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Nicotine Use Disorder</condition>
  <arm_group>
    <arm_group_label>cortical excitability in smokers</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>cortical excitability in nonsmokers</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Repetitive transcranial magnetic stimulation</intervention_name>
    <description>Repetitive transcranial magnetic stimulation for cortical excitability in smokers and non smokers</description>
    <arm_group_label>cortical excitability in nonsmokers</arm_group_label>
    <arm_group_label>cortical excitability in smokers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1 )patients must be 18 to 50 years of age. 2) heavy smokers (daily cigarettes consumption&#xD;
        of more than 20 pieces.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. cardiac pacemaker.&#xD;
&#xD;
          2. metal implants in the head.&#xD;
&#xD;
          3. Renal diseases&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>18 years</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ahmed Abdel Bakay, Assistant prof</last_name>
    <phone>01096477803</phone>
    <email>ahmedbaki2020@yahoo.com</email>
  </overall_contact>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>March 7, 2020</last_update_submitted>
  <last_update_submitted_qc>March 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Amira Moheb</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tobacco Use Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03264755
org study id: CEARORINUD
nct id: NCT03264755
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Comparison of cortical excitability between smoker and non smoker
time frame: 24 month
description: 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).
arm group label: cortical excitability in smokers
arm group type: Active Comparator
arm group label: cortical excitability in nonsmokers
arm group type: Active Comparator
intervention type: Device
intervention name: Repetitive transcranial magnetic stimulation
description: Repetitive transcranial magnetic stimulation for cortical excitability in smokers and non smokers
arm group label: cortical excitability in nonsmokers
arm group label: cortical excitability in smokers
criteria: 
gender: Male
gender based: Yes
gender description: 18 years
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ahmed Abdel Bakay, Assistant prof
phone: 01096477803
email: ahmedbaki2020@yahoo.com
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Amira Moheb
investigator title: Principal Investigator
mesh term: Tobacco Use Disorder
sharing ipd: Undecided