NCT03264755

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
2.7 years until next milestone

Study Start

First participant enrolled

May 4, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2020

Completed
Last Updated

March 10, 2020

Status Verified

September 1, 2019

Enrollment Period

7 months

First QC Date

August 23, 2017

Last Update Submit

March 7, 2020

Conditions

Nicotine Use Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

cortical excitability in smokers

ACTIVE COMPARATOR
Device: Repetitive transcranial magnetic stimulation

cortical excitability in nonsmokers

ACTIVE COMPARATOR
Device: Repetitive transcranial magnetic stimulation

Interventions

Repetitive transcranial magnetic stimulationDEVICE

Repetitive transcranial magnetic stimulation for cortical excitability in smokers and non smokers

cortical excitability in nonsmokerscortical excitability in smokers

Eligibility Criteria

Age18 Years - 50 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Details18 years
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • cardiac pacemaker.
  • metal implants in the head.
  • Renal diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 33452340DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Central Study Contacts

Ahmed Abdel Bakay, Assistant prof

CONTACT

01096477803ahmedbaki2020@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 23, 2017

First Posted

August 29, 2017

Study Start

May 4, 2020

Primary Completion

December 4, 2020

Study Completion

December 4, 2020

Last Updated

March 10, 2020

Record last verified: 2019-09