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.: PACTR202011815637562 Date of Approval: 23/11/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of transcranial direct current stimulation on outcome of patients with acute ischemic middle cerebral artery stroke
Official scientific title Effect of transcranial direct current stimulation on outcome of patients with acute ischemic middle cerebral artery stroke
Brief summary describing the background and objectives of the trial Stroke is one of the leading causes of death and disability worldwide. Cortical spreading depression is one of the factors that affect penumbra and minimizing it can lead to better clinical outcomes and quality of daily living. Transcranial direct current stimulation is one of the promising noninvasive brain stimulation techniques that was found in few animal models to reduce infarct volume and promote a better clinical recovery. The objective is to study the effect of cathodal transcranial direct current stimulation on the outcome of patients with acute middle cerebral artery stroke as regards infarct volume as seen on MRI and clinical outcome using NIHSS, mRS and Barthel index.
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 Treatment: Devices
Anticipated trial start date 30/11/2020
Actual trial start date 20/03/2021
Anticipated date of last follow up 30/11/2021
Actual Last follow-up date 01/07/2023
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 32
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 Numbered containers Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group sham transcranial direct current stimulation 1 milliampere (An initial ramp-up for 20 seconds will be followed by switching off the device for the rest of the session) for 20 minutes at first encounter after enrollment in the study, then at 60 and 150 minutes, respectively MRI DWI will be performed for patients with moderate and moderate to severe MCA stroke according to NIHSS Controls will receive sham stimulation by applying electrodes to ipsilesional motor area for 20 minutes at first encounter after enrollment in the study, then at 60 and 150 minutes, respectively. Another MRI stroke protocol (including: DWI, T1, T2, T2*, FLAIR and MRA) will be performed for controls before discharge (T1) i.e. 4-7 days after stroke onset (MRI “2”). Infarct volume will be calculated using a neuroimaging analysis software ‘ImageJ version 1.49p’. ImageJ is a public domain, Java-based image processing program developed at the National Institutes of Health. 16 Placebo
Experimental Group active transcranial direct current stimulation one milliampere for 20 minutes at first encounter after enrollment in the study, then at 60 and 150 minutes, respectively. MRI DWI will be performed for patients with moderate and moderate to severe MCA stroke according NIHSS. Cases will receive 1 mA of active cathodal tDCS via two electrodes placed on the scalp targeting ipsilesional motor area (C3 or C4) according to 10-20 system. Cathodal tDCS will be delivered for 20 minutes at first encounter after enrollment in the study, then at 60 and 150 minutes, respectively. Another MRI stroke protocol (including: DWI, T1, T2, T2*, FLAIR and MRA) will be performed for all enrolled patients before discharge (T1) i.e. 4-7 days after stroke onset (MRI “2”). Infarct volume will be calculated using a neuroimaging analysis software ‘ImageJ version 1.49p’. ImageJ is a public domain, Java-based image processing program developed at the National Institutes of Health. 16
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients presenting with first ever acute ischemic stroke involving MCA territory Patients presenting within the first 24 hours after stroke onset who were not eligible for rtPA or mechanical thrombectomy. NIHSS between 5-20: moderate and moderate to severe strokes Patients with history of intracranial surgeries or skull defects Patients with lacunar or hemorrhagic stroke Pregnant females Contraindications to MRI and /or tDCS 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 38 Year(s) 86 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 22/12/2019 Faculty of Medicine Ain Shams University Research ethics committee
Ethics Committee Address
Street address City Postal code Country
56 Ramses street Abaseyya cairo 11522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcome is measuring infarct volume growth before and after tDCS. Infarct volume will be measured on diffusion weighted imaging (DWI) on admission and on FLAIR at discharge. on admission before tDCS then 4-7 days after tDCS sessions
Secondary Outcome Secondary outcome is measuring three functional scales NIHSS on admission and before discharge mRS (modified Rankin Scale) on discharge and 3 months later Barthel index 3 months from stroke onset. on admission, before discharge and 3 months after onset of stroke
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Hospitals 56 Ramses Street, Abbaseyya Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alaa Amgad Alzahaby Nasr city Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University 56 Ramses street, Abbaseyya Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alaa Alzahaby alaa.alzahaby@gmail.com 01000337875 Nasr City
City Postal code Country Position/Affiliation
cairo Egypt Assistant lecturer of Neurology Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Nevine El Nahas nevine_elnahas@med.asu.edu.eg 01227910517 Sherouk city
City Postal code Country Position/Affiliation
Cairo Egypt Professor of Neurology Ain Shams University
Role Name Email Phone Street address
Public Enquiries Fatma Kenawy fatma.fathalla@gmail.com 01128593444 fifth settlement
City Postal code Country Position/Affiliation
cairo Egypt Lecturer of Neurology Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Study Protocol Beginning 3 months and ending 5 years following article publication Proposal should be directed to alaa.alzahaby@gmail.com Data will be available for 5 years at a third party website (Link to be included)
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