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.: PACTR201807106955779 Date of Approval: 13/07/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of repetitive transcranial magnetic stimulation on upper limb motor function and cortical excitability in stroke patients
Official scientific title Effect of repetitive transcranial magnetic stimulation on upper limb motor function and cortical excitability in stroke patients
Brief summary describing the background and objectives of the trial The upper extremity (UE) motor impairments is a very difficult challenge in stroke patients. These impairments are a result of direct damage to the primary motor cortex, the primary somatosensory cortex, secondary sensorimotor cortical areas, subcortical structures, and/or the corticospinal tract. Upper limb motor impairments result in reduced functional mobility, motor or sensory dysfunctions as well as problems with balance, coordination, postural control, and walking mechanics (gait) resulting in increased financial and social burden of stroke patients and their families. Abnormal cortical excitability and interhemispheric imbalance in stroke patients assumes that, there is reduced inhibition from the stroke affected area onto the unaffected (contralesional) hemisphere. This results in increased excitability of the contralesional hemisphere which ultimately leads to excessive interhemispheric inhibition onto ipsilesional cortical . This excessive imbalanced inhibition impede the neuroplasticity in these areas and limit the gains in motor recovery that can be achieved through rehabilitation The aim of our study is to examine and assess the effect of contralesional low frequency repetitive transcranial magnetic stimulation on the upper limb motor function recovery as well as the its effect on the cortical excitability & interhemispheric imbalance between both lesional and contralesional hemispheres. And also to show the correlation between the degree of upper limb motor dysfunction and cortical excitability in stroke 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,Stroke
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 15/01/2018
Actual trial start date 04/02/2018
Anticipated date of last follow up 05/08/2018
Actual Last follow-up date 05/08/2018
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
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 a randomization table created by a computer software program Central randomisation by phone/fax Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Conventional physical therapy upper limb rehabilitation protocol 5 times/week for two consecutive weeks 40 min to 1 hour ¿ Task-oriented training ¿ Active participation of the affected limb in different motor task training. ¿ Bilateral arm training exercise. ¿ Active-assistive range of motion exercise of the affected extremity, holding, moving, releasing of cups and cubes, will be administered by the same therapist. ¿ Facilitatory and inhibitory techniques for the weak and hyperactive muscle groups. 20 Active-Treatment of Control Group
Experimental Group Contralesional low frequency repetitive transcranial magnetic stimulation with the conventional p 5 times/week for two consecutive weeks 20-30 min Lf-rTMS plus 40 min to 1 hr upper limb rehabilitation program Focal 1 Hz rTMS will be applied to the contralesional hemisphere over the primary motor area. Each rTMS session consisted of 1,200pulses, lasting 20 to 30 minutes plus 40 to 1 hr conventional upper limb rehabilitation protocol 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a) 30 matched hemiparetic stroke patients aging between 50-65 years. b) Patients with ischemic stroke in the territory of the middle cerebral artery confirmed by physician with non-contrast computed tomographic (CT) or magnetic resonance imaging (MRI) scans of the brain. c) Mild to moderate upper-limb motor impairment verified according to (National Institutes of Health Stroke Scale [NIHSS]¿motor arm score of 1 to 15, and modified ashwarth¿s scale (1 or 1+) d) Time from onset of symptoms 3 to 6 months ( Du et al,2016). e) Stable vital signs with clear consciousness and proper cooperation with assessment and treatment. f) Successful measurement of motor-evoked potential (MEP) from the contralesional primary motor cortex (M1). g) The medical ethical committee from faculty of physical therapy, Cairo university will approve the project of the study. h) All the patients or their families will be given their written consent form. a) Patients who undergo surgical management including intravascular surgery or administration of tissue plasminogen activator . b) Patients with disturbance of consciousness (a score of eye opening of 4 and best verbal response of 5 on the Glasgow Coma Scale). c) Patients with aphasia or apparent cognitive deficits ( as hand apraxia, unilateral spatial neglect) , visual field deficits or any psychiatric disorders. d) Patients with serious general complications requiring intensive medical management (eg, pneumonia severe internal carotid artery stenosis or bilateral cerebrovascular lesion, heart failure, urinary tract infection, or mal nutritional state). e) Patients with other neurological or severe chronic diseases; ex: shoulder pain; joint deformity or complete paralysis of the affected upper limb . f) Patients with pathologic conditions or any contraindications for rTMS in the guidelines (eg, patients with metal within the brain, such as clips for aneurysms, patients with a cardiac pacemaker, pregnant women, or a history of seizures or epilepsy) . g) Patients with history of head injury with loss of consciousness. h) Use of any drugs that could have an effect on cortical excitability (ex. Antiepileptic drugs) . i) Patients previously undergo any type of treatments using transcranial magnetic stimulation . j) Refusal to sign the informed consent or could not carry out training or cooperate with assessments. Middle Aged: 45 Year(s)-64 Year(s) 50 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 11/06/2017 Faculty of physical therapy Cairo university ethical committee
Ethics Committee Address
Street address City Postal code Country
7 El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome upper limb motor function 1. Fugl-Meyer assessment for upper extremity (FMA-UE) motor function scale 2.Hand grip dynamometer cortical excitability Single pulse Transcranial Magnetic Stimulation to assess contralesional and ipsilesional active motor threshold sequential curves Upper limb motor function before and after treatment outcomes cortical excitability before treatment and sequential assessment per session
Secondary Outcome Degree of spasticity Modified Ashwarths scale Before and After treatment intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Physical Therapy and outpatient clinic - Neurology clinic. 7 El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki Giza 11432 Egypt
Stroke unit and outpatient clinic in the Neurology department, Faculty of Medicine, Cairo University 71 El Kasr El Aini, Al Manial Cairo 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Faculty of Medicine ,Cairo University 71 El Kasr El Aini, Manial, Cairo 11562 Egypt Hospital
Primary Sponsor Faculty of physical therapy Cairo university 7 El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki Giza 11432 Egypt University
COLLABORATORS
Name Street address City Postal code Country
PROF/DR: MOUSHERA HASSAN DARWESH Professor of department of neuromuscular disorders & its surgery Faculty of physical therapy Cairo University 7 El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki Giza 11432 Egypt
PROF/DR: MOHAMED SOLIMAN EL TAMMAWEY Professor of neurology department Faculty of medicine Cairo University 71 El Kasr El Aini, Manial, Cairo 11562 Egypt
PROF/DR. SALY HASSAN EL-KHOULY Professor of neurophysiology department Faculty of medicine Cairo University 71 El Kasr El Aini, Manial, Cairo 11562 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Moshera Darwish dr.moshera11@yahoo.com 02001015163617 4, Nawal street, Dokki
City Postal code Country Position/Affiliation
Cairo Egypt Prof Dr.
Role Name Email Phone Street address
Principal Investigator Engy Saleh engybm.saleh@yahoo.com 0201099445112 423z Hadayek el ahram
City Postal code Country Position/Affiliation
Giza Egypt Dr.
Role Name Email Phone Street address
Scientific Enquiries Mohammed Tamawy M.elTamawy@cu.gov.eg 0201116722551 7 mohamed zaghloul st
City Postal code Country Position/Affiliation
Cairo Egypt Prof.Dr
Role Name Email Phone Street address
Public Enquiries Sally ElKhouly sallyelkhouly@cu.edu.eg 012222286787 15 el nozha st.
City Postal code Country Position/Affiliation
Cairo Egypt Prof.Dr
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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