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.: PACTR202302883669762 Date of Approval: 27/02/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of transcranial magnetic stimulation on functional outcome in individuals with incomplete spinal cord injury: a randomized controlled study
Official scientific title Effect of transcranial magnetic stimulation on functional outcome in individuals with incomplete spinal cord injury: a randomized controlled study
Brief summary describing the background and objectives of the trial Whether SCI was traumatic or non-traumatic in origin, it is a very significant health condition. While SCI will always be life-changing, it doesn't have to undermine the possibilities of a good and fulfilling life for individuals. In clinical management of SCI, neurological outcomes are generally determined at 72 hours after injury using American Spinal Injury Association (ASIA) scoring system .This time-point has shown to provide a more precise assessment of neurological impairments after SCI .One important predictor of functional recovery is to determine whether the injury was incomplete or complete. As time passes, patients with SCI experience some spontaneous recovery of motor and sensory functions (Waters et al., 2004). Repetitive transcranial magnetic stimulation (rTMS) rehabilitation techniques, based on protocols that selectively stimulate specific pathways along the central nervous system (CNS), have been found to be effective in enhancing neurological recovery leading to improved functional abilities. It is a procedure that involves repetitively delivering biphasic magnetic pulses over a specific cortical site to provide stimulation of the corticospinal tract , primary motor cortex (M1), and spinal cord, so as to induce neuronal reorganization, which can be largely involved in the control of voluntary movements (Rossi et al., 2015). Protocols involving rTMS have been used to induce changes in the excitability of neuronal circuits with positive effects at the site of stimulation or transsynaptically at distant sites such as spinal cord circuits. The effect of high-frequency rTMS (i.e. ≥ 5Hz) includes changes in synaptic plasticity resembling long-term potentiation (LTP), as well as shifts in network excitability, activation of feedback loops, and activity dependent metaplasticity (Rossini et al., 2015). High frequency rTMS over the primary motor cortex (M1) applied at frequencies of five to 20 Hz induces increase in corticospinal excitability as indexed by a significant facilitation of motor responses. (Tergau et al., 2000). It induced changes in motor performance. These changes can be assessed by kinematic recording. Most motor cortical areas are easily accessible by transcranial magnetic stimulation (TMS). This especially applies for the primary motor cortex (M1) and the lateral premotor cortex (Fregni et al., 2006). According to the previous studies, there is no previous study compared the combined effect of TMS and Body weight supported treadmill (BWST) versus BWST alone. Previous studies revealed the effect of TMS only on spinal cord injury patients or the effect of TMS with program of resisted exercises ,this shown in the study of ( Soren Krogh et al, 2022) .The other studies that combined the TMS with a locomotor training was for a short period of time ,this shown in the study of (Kumru et al 2013 ) ,this study was conducted to cover this gap of knowledge, therefore the aim of this study was to find both the short and long term effect of TMS and BWST on functional outcome & quality of life (QOL) in patients with incomplete spinal cord injury. This study determined the effect of rTMS combined with physical therapy on functional performance after SCI to enable physiotherapist to use new technology in rehabilitation and treatment.
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 15/11/2019
Actual trial start date 01/12/2019
Anticipated date of last follow up 01/05/2022
Actual Last follow-up date 01/02/2022
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 40
Recruitment status Recruiting
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 Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group transcranial magnetic stimulation and body weight supported treadmill 3 times per week for 12 weeks 3 months High frequency repetitive transcranial magnetic stimulation applied over the vertex at 20hz for 3 days per week for one month and body weight supported treadmill applied for one hour three times per week for 3 months 20
Control Group Body weight supported treadmill One hour 3 times per week Three months Body weight supported treadmill applied for one hour three times per week for three months 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Forty male patients with traumatic incomplete spinal cord injury at mid thoracic level (T6-T12) according to American Spinal Injury Association (ASIA) scale motor and sensory for lower limb (5) . -Patient's age ranged from 25 to 45 years. -Duration of illness ranged from three months to 12 months. -Spastcity of the paretic lower limb was not more than grade 2 according to the Modified aschowrth scale (MAS). -Degree of weakness in paretic lower limb muscles wasn’t less than (grade 2) according to group muscle test.(not less than ASIA B according to ASIA scale. -Other causes of spinal cord disorders e.g : Neoplastic, Multiple Sclerosis , infected disorder of spinal cord , amyotrophic lateral sclerosis , T.B. or myelopathy. -Cardiac pacemaker Adult: 19 Year-44 Year 25 Year(s) 45 Year(s) Male
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 09/01/2023 Research ethical committee
Ethics Committee Address
Street address City Postal code Country
7 ahmed el zayat strret Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome increase at Walking index for spinal cord injury and 10 meter walk test at the experimental group After three months and followup after three months from end of treatment
Secondary Outcome Increase in SF-36 scale overall score in the experimental group At three months and follow up after three months from end of the treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Agouza rehabilitation center for military forces 24 fwah street. Agouza Cairo 1636 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmee mohamed elsaied abdelkhaelk 8 khan yunis street Elharam Giza 36387 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ahmed mohamed elsaied El haram Cairo 1626 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abeer El wishy dr.abeerelwishy2011@gmail.com 00201228088835 7 ahmed el zayat street, dokki
City Postal code Country Position/Affiliation
Giza 11432 Egypt Professor of physical therapy for neurological disorders.cairo university
Role Name Email Phone Street address
Public Enquiries Ahmed Hassanen ahmedsaid306@gmail.com 00201223138377 7 ahmed el zayat,dokki
City Postal code Country Position/Affiliation
Giza 11432 Egypt PhD student of physical therapy for neurological disorders.cairo university
Role Name Email Phone Street address
Scientific Enquiries Waleed Mansour Waleed_Talat73@yahoo.com 00201005311168 Faculty of physical therapy Benha university -benha
City Postal code Country Position/Affiliation
Qaluobya Egypt Dean of faculty of physical therapy benha university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Anonomyized individual participant data that underlie the results reported in this article ( text, tables, and figures) will be sorted on non publicly available storage. Data access will be available for 36 months after article publication for researches through email request to (ahmedsaid306@gmail.com) Study Protocol 36 months after paper publication - anonymous individual participant data that will be published in the article will be available upon request -Access criteria : researcher in the same field after submitting their study proposal Types of data permitted is meta analysis -proposal should be directed to the corresponding author (ahmedsaid306@gmail.com) and he will give the access to the data - to gain access to the data requestor will need to sign a data access agreement
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information