1. Home
  2. Approved trials
  3. » فارسی

Effect of bihemispheric transcranial direct current stimulation on the verbal function of patients with post-stroke Broca's aphasia during the subacute phase

Protocol summary

Study aim
Determining the effect of bihemispheric transcranial direct current stimulation on the verbal function of patients with post-stroke Broca's aphasia during the subacute phase
Design
A parallel, randomized, double-blinded, clinical trial with a control group
Settings and conduct
Considering the interhemispheric inhibition and neuroplastic changes, the aim of this study is to increase the neuronal excitability of the lesioned hemisphere and decrease it in the contralesional hemisphere, using tDCS. This trial will be performed in the neurology ward of Poursina Hospital, in Rasht, Iran. Thirty patients with post-stroke Broca's aphasia will be enrolled and randomly divided into 2 groups, receiving eighter active or Sham tDCS.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Incidence of aphasia after ischemic stroke, right-handed, literate (able to read and speak in Persian), able to tolerate the treatment process, P-WAB-1 score less than 92, suffering from aphasia based on P-WAB-1 criteria Exclusion criteria: hemorrhagic stroke, tdcs contraindications; metal implants, heart pacemaker, Epilepsy, seizures, taking psychoactive drugs, mental illnesses, pregnancy, brain tumors
Intervention groups
- Active tDCS (transcranial direct current stimulation) bihemispheric tDCS with 2 mA intensity will be applied for 20 minutes. Anodal stimulation will be applied to the left hemisphere F5 region. - Sham tDCS Both electrodes will be placed as in active group. Current will be applied for 3o seconds (10 seconds ramp-up, 10 seconds 2 mA and 10 seconds ramp-down). The electrodes remain in place for 20 minutes but no current will be applied to asses the placebo effect.
Main outcome variables
Improvement of verbal function based on P-WAB-1 score.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190522043673N1
Registration date: 2019-08-27, 1398/06/05
Registration timing: registered_while_recruiting

Last update: 2019-08-27, 1398/06/05
Update count: 0
Registration date
2019-08-27, 1398/06/05
Registrant information
Name
Kambiz Rohampour
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3369 0884
Email address
rohampour@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of bihemispheric transcranial direct current stimulation on the verbal function of patients with post-stroke Broca's aphasia during the subacute phase
Public title
Effect of tDCS on post-stroke Broca's aphasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Incidence of aphasia after ischemic stroke right handed literate (able to read and speak in Persian) able to tolerate the treatment process P-WAB-1 score less than 92 suffering from aphasia based on P-WAB-1 criteria
Exclusion criteria:
hemorrhagic stroke tdcs contraindications; metal implants, heart pacemaker, Epilepsy, seizures, taking psychoactive drugs mental illnesses pregnancy brain tumor
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be used; with a block size of 4; Allocation concealment will be performed using sealed envelope software. The participants will be allocated to group A or B, using blocked randomization (Block size: 4). One of the groups receive active tDCS, while the other is sham stimulated, neither the participants nor the allocator is not aware that which group will be the treatment group. The physiotherapist, applying the tDCS, is the only researcher who knows the treatment and the sham group. After treatment (or sham stimulation), the data will be analyzed by the statistician, who is either blind to the data groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants will be allocated to group A or B, using blocked randomization. Neither the participants nor the allocator is not aware that which group will be the treatment group. The physiotherapist, applying the tDCS, is the only researcher who knows the treatment and the sham group. After treatment (or sham stimulation), the data will be analyzed by the statistician, who is also blind to the traetment/sham groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Poursina Hospital, Namjou street, Emam blvd.
City
Rasht
Province
Guilan
Postal code
41937-13194
Approval date
2019-05-11, 1398/02/21
Ethics committee reference number
IR.GUMS.REC.1398.069

Health conditions studied

1

Description of health condition studied
post-stroke broca's aphasia
ICD-10 code
169.320
ICD-10 code description
Aphasia following cerebral infarction

Primary outcomes

1

Description
P-WAB-1 score
Timepoint
Before intervention - After intervention - 3 month after intervention
Method of measurement
P-WAB-1 questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
- Active tDCS (transcranial direct current stimulation); bihemispheric tDCS with 2 mA intensity will be applied for 20 minutes. Anodal stimulation will be applied to the left hemisphere F5 region.
Category
Treatment - Devices

2

Description
- Sham tDCS; Both electrodes will be placed as in active group. Current will be applied for 3o seconds (10 seconds ramp-up, 10 seconds 2 mA and 10 seconds ramp-down). The electrodes remain in place for 20 minutes but no current will be applied to asses the placebo effect.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Poursina Hospital
Full name of responsible person
Soha Yekta
Street address
Namjou street, Emam blvd.
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3332 2444
Fax
+98 13 3333 9842
Email
poursina@gums.ac.ir
Web page address
http://www.gums.ac.ir/poursina

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Shademan Nemati
Street address
Shahid Beheshti Blvd.(west), opposite of Sepah Bank, vice-chancellor for Research Building
City
Rasht
Province
Guilan
Postal code
4193853948
Phone
+98 13 3336 2889
Fax
+98 13 3336 2842
Email
research@gums.ac.ir
Web page address
http://www.gums.ac.ir/research
Grant name
Vice Chancellor for Research of Guilan University of Medical Sciences
Grant code / Reference number
97122203
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Kambiz Rohampour
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Guilan University Complex, 6th km of Tehran road,
City
Rasht
Province
Guilan
Postal code
4193853948
Phone
+98 13 3369 0884
Email
rohampour@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Alia Saberi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Namjou street, Poursina Hospital
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3369 0884
Fax
+98 13 3369 0036
Email
Alia.saberi.1@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Alia Saberi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Namjou street, Poursina Hospital
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3369 0884
Fax
+98 13 3369 0036
Email
Alia.saberi.1@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Loading...