Double point versus single point stimulation in motor rehabilitation of paretic arms among stroke patients using transcranial direct current stimulation
Objectives: Study purpose is determination of efficacy of brain stimulation with Transcranial Direct Current Stimulation(tDCS) in motor recovery of paretic upper extremities among acute ischemic stroke patients.
Design: Study population will be acute ischemic stroke patients referred to Shariati hospital in Iran. The study will be a randomized double blind clinical trial with 30 patients in each arm. ُStratified randomization will be used for treatment allocation.
Setting and conduct: After signing consents, patients will receive real or sham brain stimulation through a direct current stimulator. Patients visits will be done at baseline, and after two weeks, 4 weeks, and three months.
Participants: Participants will be acute ischemic stroke patients referred to Shariati hospital in Tehran. Major exclusion criteria will be severe global aphasia due to stroke or dementia before or due to stroke.
Intervention: Intervention arm patients will receive 5 sessions of real stimulation bihemispherically over the primary motor cortices, 30 minutes in duration and over 5 consecutive days, and another 30 minutes of real stimulation over the left dosrolateral prefrontal cortex. Sham group will receive sham stimulation over the both mentioned brain cortices for 5 sessions with 30 minutes duration at each stimulation site.
Primary outcome measure will be measurement of upper extremity motor (measured by Fugl_Meyer test) and dexterity(measured by Action Research Arm test) abilities.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015102817867N3
Registration date:2017-06-10, 1396/03/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-06-10, 1396/03/20
Registrant information
Name
Shahram Oveisgharan
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8889 6696
Email address
oveis@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Double point versus single point stimulation in motor rehabilitation of paretic arms among stroke patients using transcranial direct current stimulation
Public title
Double stimulation versus single stimulation in rehabilitation of stroke patients using transcranial direct current stimulation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Stroke patients whose symptoms start within the last 4 days; stroke patients who suffer from upper extremity paresis due to stroke.
Exclusion criteria: stroke patients with decreased level of consciousness; patients with metal foreign bodies in their heads; patients who do not sign the consent forms; patients who can not come regularly for three months after their first visit;patients with dementia before current stroke; patients who develop severe global aphasia or dementia after stroke.
Age
From 20 years old to 90 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz Blvd
City
Tehran
Postal code
Approval date
2017-02-04, 1395/11/16
Ethics committee reference number
IR.TUMS.VCR.REC.1395.1618
Health conditions studied
1
Description of health condition studied
Ischemic Stroke
ICD-10 code
I63
ICD-10 code description
Cerebral Infarction
Primary outcomes
1
Description
Upper extremity motor capacity
Timepoint
Before intervention, week 2, month 1, month 3
Method of measurement
Fugl-Meyer test
2
Description
Upper extremity dexterity
Timepoint
Before intervention, week 2, month 1, month 3
Method of measurement
Action Research Arm Test
Secondary outcomes
1
Description
Disability in the daily activities
Timepoint
Before intervention, week 2, month 1, month 3
Method of measurement
Modified Rankin Scale
Intervention groups
1
Description
Intervention group: Brain stimulation will be done through a battery-driven constant current stimulator.
Each patient's brain will be stimulated in five sessions in five consecutive days for about an hour per session. In the first 30 minutes, primary motor cortex will receive real stimulation. Anode electrode will be placed over the injured hemisphere and cathode electrode will be put over the intact hemisphere. In the 10/20 EEG system, primary motor cortex is compatible with C3/C4 points.
In the second 30 minutes of stimulation, each patient's dorsolateral prefrontal cortex will be stimulated. Anode electrode will be placed over the left dorsolateral prefrontal cortex and cathode electrodes will be put just above the right mid-orbital area. In the 10/20 EEG system, left dorsolateral prefrontal cortex is compatible with F3 point.
In both sessions, real stimulation will rise from zero to two milliamperes in 30 seconds, continue at two milliamperes for 30 minutes, and decline from two to zero milliamperes in 30 seconds.
Category
Rehabilitation
2
Description
Control group: Brain stimulation will be done through a battery-driven constant current stimulator. Each patient's brain will be stimulated in five sessions in five consecutive days for about an hour per session. In the first 30 minutes, primary motor cortex will receive shaml stimulation. Anode electrode will be placed over the injured hemisphere and cathode electrode will be put over the intact hemisphere. In the 10/20 EEG system, primary motor cortex is compatible with C3/C4 points. In the second 30 minutes of stimulation, each patient's dorsolateral prefrontal cortex will receive sham stimulation. Anode electrode will be placed over the left dorsolateral prefrontal cortex and cathode electrodes will be put just above the right mid-orbital area. In the 10/20 EEG system, left dorsolateral prefrontal cortex is compatible with F3 point.
In both sessions, stimulation will rise from zero to two milliamperes in 30 seconds, continue at zero milliamperes for 30 minutes, and decline from two to zero milliamperes in 30 seconds.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Shahram Oveisgharan
Street address
Kargar St;
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences -
Full name of responsible person
Dr. Masud Yunesian
Street address
Chamran Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical 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
Shariati hospital Tehran University of Medical Sciences
Full name of responsible person
Shahram Oveisgharan
Position
Assistant Professor of Neurology
Other areas of specialty/work
Street address
North Kargar St
City
Tehran
Postal code
Phone
+98 21 8490 2224
Fax
Email
shogh2@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shariati hospital Tehran University of Medical Sciences
Full name of responsible person
Shahram Oveisgharan
Position
Assistant Professor of Neurology
Other areas of specialty/work
Street address
North Kargar St
City
Tehran
Postal code
Phone
+98 21 8490 2224
Fax
Email
shahram.oveisgharan@rush.edu
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shariati hospital Tehran University of Medical Sciences
Full name of responsible person
Shahram Oveisgharan
Position
Assistant Professor of Neurology
Other areas of specialty/work
Street address
North Kargar St
City
Tehran
Postal code
Phone
+98 21 8490 2224
Fax
Email
shogh2@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)