Cortical Excitability and Role of rTMS in Nicotine Use Disorder

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.

Study Overview

• Status: Unknown
• Conditions: Nicotine Use Disorder
• Intervention / Treatment: Device: Repetitive transcranial magnetic stimulation

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Abdel Bakay, Assistant prof; Phone Number: 01096477803; Email: ahmedbaki2020@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of cortical excitability between smoker and non smoker	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).	24 month

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Abdelrahman AA, Noaman M, Fawzy M, Moheb A, Karim AA, Khedr EM. A double-blind randomized clinical trial of high frequency rTMS over the DLPFC on nicotine dependence, anxiety and depression. Sci Rep. 2021 Jan 15;11(1):1640. doi: 10.1038/s41598-020-80927-5.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 4, 2020
• Primary Completion (Anticipated): December 4, 2020
• Study Completion (Anticipated): December 4, 2020

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: August 28, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 7, 2020
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: CEARORINUD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No