Protocol summary
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Study aim
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The therapeutic effect of tDCS combined with routine physiotherapy on the neurological and upper limb motor function in ischemic stroke patients with hemiplegia.
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Design
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In a randomized double-blind clinical trial, randomized with sealed envelope software, on 52 patients of ischemic stroke with hemiplegia, every group includes 26 individuals.
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Settings and conduct
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patients with hemiplegia who refer to physiotherapy department,are randomized in two groups of intervention(real transcranial stimulation plus physiotherapy) and control (Sham transcranial stimulation plus physiotherapy). Someone other than the patient and examiner adjusts the device to apply or not electrical stimulation, so the examiner and patient are unaware of the assignment of individuals in the sham and real tDCS groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
age:18-65 years, unilateral ischemic stroke in middle cerebral artery, paralyzed upper limb, time post-stroke from 2 weeks to 1 month, NIHSS than 20
Exclusion criteria:
taking CNS-effective drugs except for TPA and medications used for stroke routine treatment. A history of prior stroke and other non-stroke neurological diseases, clinical instability, no compatibility with safety guidelines of tDCS
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Intervention groups
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'' intervention group'': real transcranial current stimulation plus routine physiotherapy,
''control group'' : Sham transcranial stimulation plus routine physiotherapy
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Main outcome variables
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motor function of upper limb based on MRC, stroke deficit severity based on NIHSS score
General information
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Reason for update
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Reporting the study progression and dates update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20130416013027N3
Registration date:
2020-07-11, 1399/04/21
Registration timing:
prospective
Last update:
2024-03-07, 1402/12/17
Update count:
1
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Registration date
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2020-07-11, 1399/04/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-01-01, 1399/10/12
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Expected recruitment end date
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2021-06-01, 1400/03/11
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Actual recruitment start date
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2021-12-21, 1400/09/30
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Actual recruitment end date
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2022-06-25, 1401/04/04
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Trial completion date
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2022-09-25, 1401/07/03
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Scientific title
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The effect of bihemispheric transcranial direct current stimulation combined with routine physiotherapy on the motor function of upper limb in the ischemic stroke patients with hemiplegia
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Public title
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The effect of transcranial direct current stimulation on stroke
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
age between 18 and 65 years
unilateral ischemic stroke in middle cerebral artery
upper limb plegia
stroke onset and intervention starting interval from 2 weeks to 1 month
National institude of health stroke scale (NIHSS) score less than 20 at the time of intervention
Exclusion criteria:
cognitive state score in mini mental score examination less than 24
Conditions which are not compatible to safety guidelines of brain stimulation
those with tDCS contraindication , such as pregnant patients, patients with metal implants , those having a heart pacemaker
drug history of psychoactive drugs or CNS effective drugs except tPA and medications used for stroke routine treatment .
substance abusers
Concurrent psychiatric and other non-stroke neurological disease
The use of medications blocking voltage-dependent calcium and sodium channels
History or existence of scalp eczema
Clinical instability
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Investigator
- Data analyser
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Sample size
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Target sample size:
50
Actual sample size reached:
52
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The randomization is performed using sealed envelope software. The samples are assigned to 8 randomized blocks including two groups. Therapist randomly selects one block and based on it, the subject is assigned.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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During blinding, someone other than the patient and examiner adjusts the device to apply or not electrical stimulation, so the examiner and patient are unaware of the assignment of individuals in the sham and real tDCS groups, and only the person adjusting the device, is aware of this.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-08-03, 1398/05/12
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Ethics committee reference number
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IR.GUMS.REC.1398.247
Health conditions studied
1
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Description of health condition studied
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patients with unilateral ischemic stroke having a paralyzed upper limb
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ICD-10 code
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I63.9
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ICD-10 code description
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Cerebrovascular accident-ischemic
Primary outcomes
1
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Description
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motor function of upper limb
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Timepoint
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baseline/before intervention, the final session of intervention, three months after final therapy
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Method of measurement
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Medical Research Council Scale for Muscle Strength (MRC)
Secondary outcomes
1
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Description
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neurological deficit severity
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Timepoint
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baseline and final session of intervention, three months after final therapy
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Method of measurement
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National institute of health stroke scale (NIHSS)
Intervention groups
1
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Description
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intervention group: 1.5 mA Anodal transcranial electrical stimulation on primary motor cortex of lesion hemisphere and Cathodal stimulation on anologous area of opposite hemisphere. time of stimulation is 30 minutes stimulation in 10 sessions,successive 5 sessions weekly for two weeks . stimulation device manufactured by Mindalive company from Canada.
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Category
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Rehabilitation
2
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Description
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control group : Sham transcranial direct current stimulation with1 mA intensity for 3 seconds, 30 minutes physiotherapy each session for 10 sessions, 5 successive sessions per week.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Deputy of research and technology at Guilan University of Medical Sciences
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Grant code / Reference number
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98042925
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Guilan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available