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.: PACTR202110558451583 Date of Approval: 29/10/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Therapeutic Role of rTMS in Children with ADHD a Pilot Study
Official scientific title The Therapeutic Role of Repetitive Transcranial Magnetic Stimulation in Children with Attention deficit/Hyperactivity Disorder in Egypt a Pilot Study
Brief summary describing the background and objectives of the trial Attention-deficit/hyperactivity disorder (ADHD) is a common neurobehavioral disorder of childhood characterized by impairing levels of inattention and/or hyperactivity/impulsivity. The worldwide ADHD prevalence was estimated to be 7.1% in children and adolescents, It affects an estimated 7.2 % of children and adolescents in the United Statesand 6.9% of the school aged children in Egypt . Current treatment approaches in ADHD sjowed high effectiveness , however, they are not suitable for all patients in need for treatment. Although,medications used in clinical practice are well tolerated, they have some adverese effects, and cardiovascular effects in the form of increased heart rate and blood pressure are the most important of them. These advere effects decrease tolerability and adherence to medications. Moreover, 20–35% of children and adolescents may have an inadequate response to initial stimulant treatment either due to insufficient efficacy or non-adherence and the response rate in atomoxetine is even lower, with 40% of patients without significant improvement.This reason among others raises the necessity to explore other therapeutic possibilities such as repetitive transcranial magnetic stimulation (rTMS). High frequency rTMS over motor areas or dorsolateral prefrontal cortex(DLPFC) can induce changes in the amount of endogenous dopamine release into caudate nucleus. In adults with ADHD some have described that one single session of high frequency rTMS over the right DLPFC can improve their attention. The main objective of this study isto to assess the effect of rTMS on symptom severity and the global functioning of children with Attention deficit/Hyperactivity disorder and to assess whether rTMS combined to medications is more effective than medications in patients with ADHD.
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 01/02/2018
Actual trial start date 01/08/2020
Anticipated date of last follow up 30/06/2021
Actual Last follow-up date 31/07/2021
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Repetitive transcranial magnetic stimulation and non stimulants for rTms 5 session/week for 3 weeks atomoxetine 1.2 mg/kg/day 3 weeks The rTMS will deliver a large current in a short period of time then produces a magnetic field which will induce an electric field sufficient to stimulate neurons or change the resting membrane potential in underlying cortex (Post and Keck, 2001). The rTMS will be administered using magventure R 30 stimulator with a 75mm figure-eight coil. rTMS will be delivered at 10 Hz, at 90% of the observed motor threshold, 4 seconds on-train, 26 seconds off inter-train interval with 2000 pulses per session for 5 sessions per week, for 10 sessions total (ie, 30,000 pulses total in treatment course) in the active TMS condition. The stimulus intensity was set at 90% of resting motor threshold the F4 location from the EEG 10-20 system will be used target the right dorsolateral pre-frontal cortex. Participants who will receive less than 75% of number of sessions (12 session) will be considered dropout. 30
Control Group Sham rTMS and Atomoxetine 5 sessions/week for 3 weeks total of 15 sham rTMS sessions Atomoxetine 1.2mg/kg/day 3 weeks control group that will be treated by non-stimulants and will receive 15 sessions of sham rTMS. For the sham rTMS, the coil will be tilted over the right dorsolateral pre-frontal cortex without touching the scalp. 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients diagnosed with ADHD according to DSM IV Age ranges 7-12 years old All patients will be on the same type of medications throughout the duration of the study (Atomoxetine 1.2 mg/kg/day) Factors that might increase the risk of seizure with TMS such as a history of a seizure disorder, febrile seizures during childhood, known brain lesions, or a history of major head trauma involving loss of consciousness for more than 5 minutes. Specific contraindications to magnetic stimulation such as any metallic object implanted in the skull (with the exception of oral dental devices), an implanted medication pump or cochlear implant, implanted intra-cardiac lines or pacemaker. Comorbid diagnosis of autism spectrum disorder, bipolar disorder, obsessive-compulsive disorder, conduct disorder, Tourette disorder or other tic disorders, schizophrenia, schizoaffective disorder, or any other psychotic disorder. Any other neurological disorders. Child: 6 Year-12 Year 6 Year(s) 12 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 10/01/2018 Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
38 Abbassia Square, Cairo 11591 Egypt
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 10/01/2021 FMASU REC
Ethics Committee Address
Street address City Postal code Country
38 Abbasia square Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Efficacy was assessed as a primary outcome by changes in the Clinical Global Impression-Improvement (CGI-I) and childrens global assessment scale and the change will be compared between the 2 groups 3 points, at the start of the study, after they receive 10 sessions of rTMS and 1 month after the end of the rTMS sessions.
Secondary Outcome The change in the scores of revised conners parent rating scale Long form CPRS-R-L from baseline, midpoint and end of the study will be compared between the 2 groups. at 3 points, at the start of the study, after they receive 10 sessions of rTMS and 1 month after the end of the rTMS sessions.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
AIn Shams University faculty of medicine Psychiatry Institute 38 Abbassia Square Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mostafa Shohdy 61 El hussein street, AL GIZA Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor FACULTY OF MEDCINE AIN SHAMS UNIVERSITY 38 ABBASSIA SQUARE CAIRO Egypt University
COLLABORATORS
Name Street address City Postal code Country
Nahla Nagy 38 Abbassia square Cairo Egypt
Ghada Refaat 38 Abbassia square Cairo Egypt
hussein El kholy 38 Abbassia square Cairo Egypt
Sherine Ahmed 38 Abbassia sqaure Cairo Egypt
dalia Abdelmoneim 38 Abbassia square cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mostafa Shohdy dr.shohdyy@gmail.com 001001395441 61 EL Hussein street Mohandsien
City Postal code Country Position/Affiliation
El GIza Egypt Msc assistant lecturer of Psychiatry
Role Name Email Phone Street address
Scientific Enquiries nahla nagy nahlanagy64@yahoo.com 001006162480 38 Abbassia square
City Postal code Country Position/Affiliation
Cairo Egypt prof of psychiatry
Role Name Email Phone Street address
Public Enquiries hussein elkholy drhelkholy@gmail.com 001114441980 38 Abbassia square
City Postal code Country Position/Affiliation
Cairo Egypt Professor of Psychiatry
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all individual participants data collected during the trial will be availbale after deidentification Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol immediate following publication anyone who wants to access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
proposals should be directed to Dr.shohdyy@gmail.com No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 25/10/2021 This is the required extension of the Ethical committee approval TRUE, FMASU REC, 38 Abbasia square, Cairo , 11591, Egypt, , 10 Jan 2021, 20226857539, contactus@med.asu.edu.eg, 15968_15617_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 10/08/2021 As This studey is self funded and upon request of the trial reviewer Mostafa Shohdy, 61 El hussein street,, AL GIZA, , Egypt, Self Funded,