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IRCT20190922044839N2 IRCT 2021-08-22 Tabriz University of Medical Sciences Immediate effects of transcranial direct current stimulation on upper extremity performance under dual-task condition in stroke Immediate effects of transcranial direct current stimulation of motor and cognitive cortex on upper extremity performance under dual-task condition in people with subacute stroke 2021-03-21 anticipated 30 Complete https://irct.ir/trial/53263 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple individual randomization via a statistical software will be performed. We will use the Win Pepi for making randomization order. Allocation concealment will be performed by the secretary of the assessment center, Blinding description: All participants in this study will be blind to their allocation to study groups (motor cortex stimulation, cognitive cortex stimulation and placebo). The outcome assessor, before and after intervention, will be blind to the allocation as well. However, the physiotherapist, study designer, statistical analyst and the committee of safety and data supervision will not be blind. N/A Stroke. Intervention 1: Intervention group 1: Motor cortex stimulation: The participants in the motor cortex intervention group will receive one bilateral tDCS treatment session with the intensity of 1 milliamperes for 20 minutes in the primary motor area (M1). In this group, the anode electrode will be placed on the M1 area of the involved hemisphere and the cathode electrode will be placed on the M1 area of the intact hemisphere. It should be noted that the tDCS device is a nerve modulator device that includes a battery and at least two electrodes. The battery has a resistance of 9 volts. Each device must have only one anode source and one cathode evolution, one of which must be located on the head. The changes are covered with a sponge soaked in saline or other semiconductor material. The size of the changes varies between 16, 25, 35, 36 square centimeters. 2mA is the highest current strongest tested by experience, but powerful devices have increased dramatically (3-4mA). The most used current density is in the range of 0.028-0.06 current per square centimeter. Intervention 2: Intervention group 2: Cognitive cortex stimulation: The participants in the motor cortex intervention group will receive one bilateral tDCS treatment session with the intensity of 1 milliamperes for 20 minutes in the dorsolateral prefrontal cortex (DLPFC). In this group, the anode electrode will be placed on the DLPFC area of the involved hemisphere and the cathode electrode will be placed on the DLPFC area of the intact hemisphere. It should be noted that the tDCS device is a nerve modulator device that includes a battery and at least two electrodes. The battery has a resistance of 9 volts. Each device must have only one anode source and one cathode evolution, one of which must be located on the head. The changes are covered with a sponge soaked in saline or other semiconductor material. The size of the changes varies between 16, 25, 35, 36 square centimeters. 2mA is the highest current strongest tested by experience, but powerful devices have increased dramatically (3-4mA). The most used current density is in the range of 0.028-0.06 current per square centimeter. Intervention 3: Control group: Placebo: Cognitive cortex stimulation: The participants in the control group will receive a tDCS session with an elctrode placement similar to either of motor intervention group or cognitive intervention group, however they will receive tDCS only for the first 30 seconds and the rest of the time will be currentless. It should be noted that the tDCS device is a nerve modulator device that includes a battery and at least two electrodes. The battery has a resistance of 9 volts. Each device must have only one anode source and one cathode evolution, one of which must be located on the head. The changes are covered with a sponge soaked in saline or other semiconductor material. The size of the changes varies between 16, 25, 35, 36 square centimeters. 2mA is the highest current strongest tested by experience, but powerful devices have increased dramatically (3-4mA). The most used current density is in the range of 0.028-0.06 current per square centimeter. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I have to provide all the data to the research sponsor.
public Tabassom Ghanavati
29 Bahman Blvd, Tabriz University, Faculty of Rehabilitation Sciences
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3337 2072 ghanavatit@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Tabassom Ghanavati
29th Bahman BLVD, Tabriz University, Rehabilitation Faculty
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3337 2072 ghanavatit@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Physical ability to complete the motor activities required in examine by the examiner (ability to tap with the finger and perform a Purdepeg board test) Awareness and ability to communicate with the examiner and therapist Level of cognition enough to understand the test (score 22 or higher on the short test of mental state by the examiner) Score less than 18 upper limbs in the Fugel_Meyer test The first unilateral stroke that is at least 4 weeks old Confirmation of a stroke by one of the methods of brain imaging by a doctor 18 years no limit Both Contraindications to tDCS include: having a pacemaker, metal implants, a history of seizures, a skin rash, allergies or sores where the electrodes are placed, and cranial skin sensitivity. Severe upper limb pain (visual pain scale greater than 5) speech problem Existence of orthopedic or neurological disorder in the upper limb involved Upper extremity spasticity of less than 2 or more than 15 on the modified Ashworth scale I64 Stroke, not specified as haemorrhage or infarction Rehabilitation Rehabilitation Placebo Intervention group 1: Motor cortex stimulation: The participants in the motor cortex intervention group will receive one bilateral tDCS treatment session with the intensity of 1 milliamperes for 20 minutes in the primary motor area (M1). In this group, the anode electrode will be placed on the M1 area of the involved hemisphere and the cathode electrode will be placed on the M1 area of the intact hemisphere. It should be noted that the tDCS device is a nerve modulator device that includes a battery and at least two electrodes. The battery has a resistance of 9 volts. Each device must have only one anode source and one cathode evolution, one of which must be located on the head. The changes are covered with a sponge soaked in saline or other semiconductor material. The size of the changes varies between 16, 25, 35, 36 square centimeters. 2mA is the highest current strongest tested by experience, but powerful devices have increased dramatically (3-4mA). The most used current density is in the range of 0.028-0.06 current per square centimeter. Intervention group 2: Cognitive cortex stimulation: The participants in the motor cortex intervention group will receive one bilateral tDCS treatment session with the intensity of 1 milliamperes for 20 minutes in the dorsolateral prefrontal cortex (DLPFC). In this group, the anode electrode will be placed on the DLPFC area of the involved hemisphere and the cathode electrode will be placed on the DLPFC area of the intact hemisphere. It should be noted that the tDCS device is a nerve modulator device that includes a battery and at least two electrodes. The battery has a resistance of 9 volts. Each device must have only one anode source and one cathode evolution, one of which must be located on the head. The changes are covered with a sponge soaked in saline or other semiconductor material. The size of the changes varies between 16, 25, 35, 36 square centimeters. 2mA is the highest current strongest tested by experience, but powerful devices have increased dramatically (3-4mA). The most used current density is in the range of 0.028-0.06 current per square centimeter. Control group: Placebo: Cognitive cortex stimulation: The participants in the control group will receive a tDCS session with an elctrode placement similar to either of motor intervention group or cognitive intervention group, however they will receive tDCS only for the first 30 seconds and the rest of the time will be currentless. It should be noted that the tDCS device is a nerve modulator device that includes a battery and at least two electrodes. The battery has a resistance of 9 volts. Each device must have only one anode source and one cathode evolution, one of which must be located on the head. The changes are covered with a sponge soaked in saline or other semiconductor material. The size of the changes varies between 16, 25, 35, 36 square centimeters. 2mA is the highest current strongest tested by experience, but powerful devices have increased dramatically (3-4mA). The most used current density is in the range of 0.028-0.06 current per square centimeter. Cognitive test score of Auditory Stroop test. Timepoint: Before intervention and immediately after intervention. Method of measurement: Software. Motion test score of unilateral simple Fugl_meyer test. Timepoint: Before intervention and immediately after intervention. Method of measurement: Software. Motion test score of Purdue Pegboard board test. Timepoint: Before intervention and immediately after intervention. Method of measurement: Examiner. Cost of cognitive dual task conditions for combining Purdue Pegboard board test and Auditory Stroop test. Timepoint: Before intervention and immediately after intervention. Method of measurement: Voice recording and calculation. Cost of cognitive dual-task conditions for combining unilateral simple Fugl_meyer test and Auditory Stroop test. Timepoint: Before intervention and immediately after intervention. Method of measurement: Voice recording and calculation. Cost of dual task conditions for combining Purdue Pegboard board test and Auditory Stroop test. Timepoint: Before intervention and immediately after intervention. Method of measurement: Calculation. Cost of dual task conditions to combine unilateral simple Fugl_meyer test and Auditory Stroop test. Timepoint: Before intervention and immediately after intervention. Method of measurement: Voice recording and calculation. Tabriz University of Medical Sciences Approved 2020-11-01 Ethics committee of Tabriz University of Medical Sciences 29th Bahman Blvd, Tabriz University, Faculty of Rehabilitation Sciences Tabriz East Azarbaijan Iran (Islamic Republic of)