Cortical Excitability and Role of rTMS in Nicotine Use Disorder

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03264755
Collaborator
(none)
60
2
7

Study Details

Study Description

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
  • Device: Repetitive transcranial magnetic stimulation
N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
May 4, 2020
Anticipated Primary Completion Date :
Dec 4, 2020
Anticipated Study Completion Date :
Dec 4, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Comparison of cortical excitability between smoker and non smoker [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amira Moheb, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT03264755
Other Study ID Numbers:
  • CEARORINUD
First Posted:
Aug 29, 2017
Last Update Posted:
Mar 10, 2020
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2020