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Evaluating the effects of a single session unihemispheric concurrent dual-site transcranial direct currents of primary cortex-dorsolateral prefrontal cortex on upper extremity motor performance in patients with subacute stroke

Protocol summary

Summary
Objectives: Effects of Anodal- Transcranial Direct Current Stimulation, Unihemispheric Concurrent Dual-Site (a-tDCSUCDS) on upper limb motor performance in individuals with stroke has not been clearly evaluated yet. Therefore, the purpose of the present study was to evaluate the effects of a-tDCSUCDS of primary motor cortex and dorsolateral prefrontal cortex (M1-DLPFC) on the upper limb motor performance in patients with subacute stroke. Design: A single blind, before-after study, single arm study Methods: a-tDCSUCDS is a new tDCS technique in which two active electrodes from two separated channels are placed unilaterally over two functionally related target sites, i.e. primary cortex (M1) and dorsolateral prefrontal cortex (DLPFC). In this technique the cathode electrodes are positioned over the contralateral supraorbital area. Thirteen patients suffering from subacute stroke will participate in three sessions of testing receiving three different experimental conditions in random order: twenty minutes of conventional a-tDCS of M1, 20 minutes of a-tDCSUCDS of M1-DLPFC, and 20 minutes sham a-tDCSUCDS of M1-DLPFC. Washing out period: 72 hours Outcome measures: Fugl meyer assessment tool, 9 pin Pegboard performance (time to completion), and reaction time custom designed software to evaluate the upper extremity reaction time. All these outcomes will be measured before, immediately after and 30 minutes after the application of a-tDCSs. Inclusion criteria: first stroke, subacute stroke, communication ability, spasticity of 3 or lesser on modified Ashworth scale, no botulinum injection in last 3 months, and memory or cognitive disorders. Exclusion criteria: any pain or discomfort during the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015012520787N1
Registration date: 2015-09-16, 1394/06/25
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-09-16, 1394/06/25
Registrant information
Name
Leila Rahnama
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0039
Email address
l.rahnama@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Private resources.
Expected recruitment start date
2015-09-21, 1394/06/30
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of a single session unihemispheric concurrent dual-site transcranial direct currents of primary cortex-dorsolateral prefrontal cortex on upper extremity motor performance in patients with subacute stroke
Public title
Effects of transcranial direct currents on motor performance in patients with stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: first stroke, subacute stroke (1-6 months after stroke), communication ability , and mild to moderate hemiparesis, spasticity of 3 or less on modified Ashworth scale, no botulinum injection in last 3 months, no memory or cognitive disorders, no deformity or contractures in upper extremities, no pacemaker, no narcotic addiction, no psychological problems and signing the informed consent form. Exclusion criteria: Patient’s unwillingness to participate or continue the study, Convulsion and reporting pain or discomfort during the intervention.
Age
From 30 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 13
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
A single arm study in which each participant receives all 3 types of interventions with wash out period of 72 hours. Single blind in a way that patients were not aware whether they receive real tDCS or the sham.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of University of Social Welfare and Rehabilitation Sciences
Street address
Koudakyar St., Daneshjou Blvd., Evin
City
Tehran
Postal code
1985713834
Approval date
2015-05-24, 1394/03/03
Ethics committee reference number
IR.USWR.REC.1394.6

Health conditions studied

1

Description of health condition studied
Stroke (Cerebrovascular accident)
ICD-10 code
I64
ICD-10 code description
Stroke, not specified as haemorrhage or infarction

Primary outcomes

1

Description
Reaction time
Timepoint
Before intervention, immediately and 30 minutes after, (72 h interval among different interventions)
Method of measurement
Custom made software

2

Description
Time of performance
Timepoint
Before intervention, immediately and 30 minutes after, (72 h interval among different interventions)
Method of measurement
9-pin peg board

3

Description
Motor performance
Timepoint
Before intervention, immediately and 30 minutes after, (72 h interval among different interventions)
Method of measurement
Fugl-Meyer Assessment

Secondary outcomes

empty

Intervention groups

1

Description
Thirteen patients suffering from subacute stroke will participate in three randomly selected sessions of testing receiving three different experimental conditions including: twenty minutes of conventional anodal transcranial direct current of primary motor cortex, 20 minutes of anodal unihemispheric concurrent dual-site transcranial direct current of primary motor cortex-dorsolateral prefrontal cortex and 20 minutes sham anodal unihemispheric concurrent dual-site transcranial direct current of primary motor cortex-dorsolateral prefrontal cortex. Therefore, each participant receives two types of transcranial direct current and a session of sham. As for anodal unihemispheric concurrent dual-site transcranial direct current, two active electrodes from two separated channels are placed unilaterally over two functionally related target sites, i.e. primary cortex and dorsolateral prefrontal cortex . In this technique the cathode electrodes are positioned over the contralateral supraorbital area.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Rofeideh Rehabilitation Hospital
Full name of responsible person
Amir Hossein Kahlaei
Street address
Nemati St., Shahid Soleimani Ave., Gheitarieh
City
Tehran

2

Recruitment center
Name of recruitment center
Asma Rehabilitation Center
Full name of responsible person
Marzieh Afkhami
Street address
Number 20 St., Yousefabad Ave.
City
Tehran

3

Recruitment center
Name of recruitment center
Akhavan Rehabilitation Center
Full name of responsible person
Leila Rahnama
Street address
Asadimanesh St., Near Monirieh Sq., Valiasr Ave
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Dr. Hamid-Reza Khankeh
Street address
Vice Chancellor for Research, University of Social Welfare and Rehabilitation Sciences, Koudakyar St., Daneshjou Blvd., Evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, University of Social Welfare and Rehabilitation Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Sahar Toluee
Position
Master of Science student
Other areas of specialty/work
Street address
Department of Physiotherapy, University of Social Welfare and Rehabilitation Sciences, Koudakyar St., Daneshjou Blvd., Evin
City
Tehran
Postal code
1985713834
Phone
+98 22180039
Fax
Email
stoluee69@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Social welfare and Rehabilitation Sciences
Full name of responsible person
Leila Rahnama
Position
Assistant Professor/PhD
Other areas of specialty/work
Street address
Department of Physiotherapy, University of Social Welfare and Rehabilitation Sciences, Koudakyar St., Daneshjou Blvd., Evin
City
Tehran
Postal code
1985713834
Phone
+98 22180039
Fax
Email
lrahnama@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Social welfare and Rehabilitation Sciences
Full name of responsible person
Leila Rahnama
Position
Assistant Professor, PhD.
Other areas of specialty/work
Street address
Department of Physiotherapy, University of Social Welfare and Rehabilitation Sciences, Koudakyar St., Daneshjou Blvd., Evin
City
Tehran
Postal code
1985713834
Phone
+98 21 2218 0039
Fax
Email
lrahnama@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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