Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202006900365423 Date of Approval: 29/06/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A clinical trial to assess the role of repetitive Transcranial Magnetic Stimulation (rTMS) in Smoking Cessation in an Egyptian Sample
Official scientific title A clinical trial to assess the role of repetitive Transcranial Magnetic Stimulation (rTMS) in Smoking Cessation in an Egyptian Sample
Brief summary describing the background and objectives of the trial The World Health Organization (WHO) reported that tobacco use continues to be the leading global cause of preventable death with almost 6 million deaths each year (World Health Organization, 2011). Although the prevalence is declining worldwide, it still seems to be increasing in the Eastern Mediterranean region.Despite the well-documented morbidity and mortality, estimated prevalence of smoking any tobacco product among males aged >= 15 years in Egypt has been rising from 43.9% in 2010 to 49.9% in 2015 and is predicted to continue rising until 2025 (World Health Organization, retrieved 2017). Alongside available approved medications, Repetitive transcranial magnetic stimulation (rTMS) is a tool that can potentially induce dopamine release and long-lasting changes in neural excitability (Dinur-Klein, et al., 2014). High frequency rTMS at the left dorsolateral prefrontal cortex (LDPFC) has been shown to modulate cigarette cue-induced cravings, hypothetically due to mimicking nicotine actions on brain reward system (Pripfl, Tomova, Riecansky, & Lamm, 2014) . It has also been shown to induce dopamine release in the caudate nucleus (Strafella, Paus, & Barrett, 2001). Use of such tool could provide a potential method for smoking cessation. This clinical trial aims to asses the point prevalence of smoking cessation after 6 months of a course of rTMS treatment and the reduction of cravings and smoked tobacco over the same course.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/08/2019
Actual trial start date 14/09/2019
Anticipated date of last follow up 12/06/2020
Actual Last follow-up date 12/06/2020
Anticipated target sample size (number of participants) 54
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL https://journals.lww.com/addictiondisorders/Abstract/9000/A_Clinical_Trial_to_Assess_the_Role_of_Repetitive.99626.aspx
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Active repetitive Transcranial Magnetic stimulation Patients will receive at least 6 active rTMS sessions over 2 weeks Sessions received over 2 weeks (3 sessions/week), followed up 6 months after treatment for relapse/abstinence rates Alongside psychotherapy, 27 patients for whom rTMS will be administered using a Magventure R 30 stimulator with a 75 mm figure-eight coil. Patients will be stimulated at a frequency of 10 Hz in 20 trains/day, each containing 50 pulses, with an inter-train interval of 15s. Stimulation intensity will be done at 100% of the motor threshold at the left dorsolateral prefrontal cortex, determined by moving the TMS coil 6 cm anterior to M1 along a parasagittal line. Follow up using Arabic Tobacco Craving Questionnaire-12 (ATCQ-12), Nicotine Use Inventory (NUI) and number of daily smoked tobacco products at weeks 2, 4, 12 and NUI and number of daily smoked tobacco products at week 24 27
Control Group Sham repetitive Transcranial Magnetic Stimulation Patients will receive 6 sham rTMS sessions over 2 weeks. Sessions received over 2 weeks. Followed up for 6 months after treatment. Alongside psychotherapy, 27 age and gender matched patients for whom device coil will be tilted over left dorsolateral pre-frontal cortex touching the scalp. The sham procedure will be performed by an operator not involved in other investigations and parameters for blinding purposes. Follow up using Arabic Tobacco Craving Questionnaire-12 (ATCQ-12), Nicotine Use Inventory (NUI) and number of daily smoked tobacco products at weeks 2, 4, 12 and NUI and number of daily smoked tobacco products at week 24 27 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Both genders Ages 18 to 60 years. Current smokers or waterpipe users. Meet criteria for nicotine dependence as determined by the FTND. Willing to provide informed consent. Able to comply with protocol requirements and willing to complete all study procedures. Current dependence, defined by ICD-10 criteria, on any psychoactive substances other than nicotine or caffeine or received substance use treatment within past 30 days History of serious mental illness such as: Bipolar disorder, Psychotic illness, Major Depression with psychotic features and other psychiatric illness such as OCD or eating disorders Contraindication to rTMS (history of neurological disorder or seizure, increased intracranial pressure, brain surgery, or History of autoimmune, endocrine, viral, or vascular disorder affecting the brain. History or MRI evidence of neurological disorder that would lead to local or diffuse brain lesions or significant physical impairment. Unstable cardiac disease, uncontrolled hypertension, severe renal or liver insufficiency. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/01/2018 Ain Shams University Faculty of Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ain Shams University Faculty of Medicine,Abbasia, Cairo, Egypt Cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Point prevalence of abstinence to be defined as a self-report of no smoking or other tobacco use (or other nicotine product use during the treatment phases) in the previous 7 days Week 2, 4, 12, 24 post-treatment
Secondary Outcome Time to first relapse as defined by self-report after tobacco quit date AND end of rTMS sessions Week 2, 4, 12, 24 post-treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Institute of Psychiatry Faculty of Medicine, Ain Shams University, Ramses street, Abbasseya Cairo 11566 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mayar Medhat Nawara Mohyi ElDin Nawara Ain Shams University Institute of Psychiatry, Ain Shams University Faculty of Medicine, Abbasia, Cairo Cairo 11566 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Institute of Psychiatry Ain Shams University Insitute of Psychiatry, Faculty of Medicine, Ain Shams University, Abbasia, Cairo Cairo 11566 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Hussien ElKholy Ain Shams University Faculty of Medicine, Department of psychiatry, Abbaseya Cairo 11566 Egypt
Gihan ElNahas Ain Shams University Faculty of Medicine, Department of Psychiatry, Abbaseya Cairo 11566 Egypt
Mahmoud ElHabiby Ain Shams University Faculty of Medicine, Department of Psychiatry, Abbaseya Cairo 11566 Egypt
Menan AbdelMaksoud Rabie Ain Shams University Faculty of Medicine, Department of Psychiatry, Abbaseya Cairo 11566 Egypt
Mohamed Hossam ElDin Abdelmoneam Ain Shams University Faculty of Medicine, Department of Psychiatry, Abbaseya Cairo 11566 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mayar Nawara mayar_nawara@med.asu.edu.eg +201227201306 Ain Shams University Institute of Psychiatry, Faculty of Medicine Ain Shams University
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Assistant Lecturer of Psychiatry in Department of Neuropsychiatry at Ain Shams University Faculty of Medicine
Role Name Email Phone Street address
Scientific Enquiries Hussien Elkholy h.elkholy@med.asu.edu +201114441980 Ain Shams University Institute of Psychiatry, Ain Shams University Faculty of Medicine, Abbasia
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Assistant Professor in Department of Neuropsychiatry at Ain Shams University Faculty of Medicine
Role Name Email Phone Street address
Public Enquiries Mayar Nawara mayar_nawara@med.asu.edu.eg +201227201306 Ain Shams University Institute of Psychiatry, Ain Shams University Faculty of Medicine, Abbasia
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Assistant Lecturer of Psychiatry in department of Neuropsychiatry Ain Shams University Faculty of Medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data from the study will be available for sharing upon reasonabl request by an academically affiliated entity after publication of the study within 1 year for a period to be determined by collaborators afterwards. Data will be deidentified and provided after review of suitted proposals by collaborators. Study Protocol Within a year of publication of the study Researchers who provide a methodologically sound proposal, ethical commitee approval and trial registry number will contact corresponding author or PI within a year of publication and data will be shared after deidentification (tables, figures, appendices...,etc.). Requests will be reviewed as per request by collaborators. Data can be used for meta-analyses or to fulfil aiks of submitted proposals. A data access agreement will have to be signed.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 14/09/2021 10/08/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 14/09/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information