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
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
Design
This study is a parallel double-blinded randomized clinical controlled trial. The referred people will be randomly allocated to one of the three groups of motor cortex stimulation, cognitive cortex stimulation and placebo
Settings and conduct
Initialy, patients with stroke were refered by a neurologist based on inclusion and exclusion criteria, fulfilling a written informed consent form. Then they were randomly allocated into three groups of motor, cognition and control. After baseline assessment of outcomes, participants in motor group will receive bilateral tDCS of 1 miliamper on primary motor cortex area (M1) for 20 minutes (with cathode electrode on intact M1 and anode electrode on involed M1). Participants in cognitive group will receive bilateral tDCS of 1 miliamper on dorsolateral prefrontal cortex area (DLPFC) for 20 minutes minutes (with cathode electrode on intact M1 and anode electrode on involed M1). Participants in control group will receive bilateral tDCS of 1 miliamper for only the initial and final 30 sendonds while during the rest of the time there will be no current. The electrode placement will be similar to either of motor or cognitive group. The secondary assessment of outcomes will be performed immidiately after tDCS treatment.
Participants/Inclusion and exclusion criteria
Patients with the first stroke who are at least 18 years old and have no other neurological or psychiatric problems and contraindications to the use of tDCS
Cognitive score, motor score, motor dual task difference, cognitive dual task difference
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190922044839N2
Registration date:2021-08-22, 1400/05/31
Registration timing:registered_while_recruiting
Last update:2021-08-22, 1400/05/31
Update count:0
Registration date
2021-08-22, 1400/05/31
Registrant information
Name
Tabassom Ghanavati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 2072
Email address
ghanavatit@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Immediate effects of transcranial direct current stimulation on upper extremity performance under dual-task condition in stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
29th Bahman Blvd, Tabriz University, Faculty of Rehabilitation Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2020-11-01, 1399/08/11
Ethics committee reference number
IR.TBZMED.REC.1399.740
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I64
ICD-10 code description
Stroke, not specified as haemorrhage or infarction
Primary outcomes
1
Description
Cognitive test score of Auditory Stroop test
Timepoint
Before intervention and immediately after intervention
Method of measurement
Software
2
Description
Motion test score of unilateral simple Fugl_meyer test
Timepoint
Before intervention and immediately after intervention
Method of measurement
Software
3
Description
Motion test score of Purdue Pegboard board test
Timepoint
Before intervention and immediately after intervention
Method of measurement
Examiner
4
Description
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
5
Description
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
6
Description
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
7
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
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.
Category
Rehabilitation
3
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy Clinic of Tabriz Rehabilitation Faculty
Full name of responsible person
Tabassom Ghanavati
Street address
29 Bahman Blvd, Tabriz University, Faculty of Rehabilitation Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3337 2072
Email
ghanavatit@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Sami'ei
Street address
No. 2 Central Building, Tabriz University of Medical Sciences, University Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
iro@tbzmed.ac.ir
Web page address
http://portal-en.tbzmed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Tabassom Ghanavati
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
29 Bahman Blvd, Tabriz University, Faculty of Rehabilitation Sciences