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.: PACTR202009622405087 Date of Registration: 14/09/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of Repetitive Peripheral Magnetic Stimulation in reduction of spasticity in neurology patients
Official scientific title Efficacy of Repetitive Peripheral Magnetic Stimulation in reduction of limb spasticity in neurology patients
Brief summary describing the background and objectives of the trial Non-invasive brain stimulation,including transcranial magnetic stimulation , has the capacity to modulate cortical excitability and to optimize brain plasticity . Repetitive peripheral magnetic stimulation is a novel modality of transcranial magnetic stimulation that shows promising results in rehabilitation of neurological disorders .This research will study the effects of peripheral stimulation in modulating limb spasticity in neurology patients
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/03/2020
Actual trial start date 01/03/2020
Anticipated date of last follow up 01/06/2020
Actual Last follow-up date 30/07/2020
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 36
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group repetitive peripheral magnetic stimulation every other day 8 sessions of stimulation Peripheral magnetic stimulation using intermittent theta burst stimulation (piTBS) was performed over the belly of spastic muscles. The iTBS protocol consisted of 10 bursts, each of which was composed of three stimuli at 50 Hz, repeated at a theta frequency of 5 Hz every 10 seconds for a total of 600 stimuli of total duration of 200 seconds. Stimulation was administered using a MagVenture dynamic liquid cooled Film Coil (figure of eight, diameter 17 cm, biphasic waveform) connected to a high-frequency magnetic Magpro X100 Stimulator. Stimulation was done with the patient reclining supine. The coil was held tangentially to the skin with the handle at 90 degrees to the longitudinal axis of the targeted muscle. Stimulus intensity was set at supra-threshold intensity of the stimulated muscle so that visible muscle contraction is perceived by the operator. 25
Control Group sham peripheral magnetic stimulation every other day 8 sessions sham stimulation using an optically similar shielded sham coil was applied on the belly of spastic muscles 11 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age between 18-65 yrs. Disease duration >6 months Spasticity on modified Ashworth scale ≥ 1+ that has been present over the past month. Recent (<4 months) botulinum toxin injection A metal plate along the spastic limbs Patients with pacemakers Pregnant females. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 23/08/2017 research ethics committee faculty of medicine Ain shams university
Ethics Committee Address
Street address City Postal code Country
Abbassia Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Reduction of spasticity by a change in modified Ashworth scale (mAS) At baseline , and After completion of the 8th stimulation session
Secondary Outcome Reduction of estimated dose of Onabotulinum toxin A (eBTD). At baseline , and After completion of the 8th stimulation session
Secondary Outcome in a group of patients , assessment of the the function with Fugel Meyer scale will be done at baseline , and after completion of the 8th session
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Neuromodulation unit Neurology dep. Ain shams University Abbassia square Cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Nevine El nahas Abbassia Cairo 11591 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine Ain shams university Abbasia cairo 11591 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hossam Shokri Abbassia cairo 11591 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nevine El Nahas nevine_elnahas@med.asu.edu.eg 00201227910517 Abassia
City Postal code Country Position/Affiliation
cairo 11591 Egypt Professor of Neurology Head of neuromodulation lab
Role Name Email Phone Street address
Public Enquiries Fatma Kenawy fatma.fathalla@gmai.com 00201128593444 abbassia
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Lecturer of Neurology
Role Name Email Phone Street address
Scientific Enquiries Randa Amin randamoustafa@med.asu.edu.eg 00971509254544 Abbassia
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Lecturer of Neurology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD will be shared as requested. Study Protocol Beginning 9 months and ending 36 months following article publication controlled ,Researchers who provide a methodologically sound proposal.For individual participant meta analysis. Proposal may be submitted up to 36 months following article publication. After 36 months the data will be available in out University’s data warehouse but without investigator support other than deposited metadata
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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