Evaluation of the effect of Unihemispheric Concurrent Dual-Site Transcranial Direct Current Stimulation of Dorsolateral Prefrontal Cortex AND primary motor cortex on improvement of lower limb motor function in patients with chronic stroke: A double-blind controlled clinical trial
Investigating the effect of unilateral tDCS stimulation of primary motor cortex and dorsolateral prefrontal cortex on the improvement of upper limb function in chronic stroke patients
Design
A clinical trial with a double-blind randomized control group
Settings and conduct
By referring to the neurological center, after examining the stroke patients
by the neurologist, we will provide the necessary explanations about the study for the people who meet the entry criteria. Then, if they agree to participate, they sign the consent form. After obtaining informed consent, the questionnaire of personal information and disease will be completed and the cognitive status will be done with the Mini–Mental State Examination (MMSE) test. Then, to measure the severity of spasticity of patients' knee flexor muscles and functional status, the Persian version of the Modified Modified Ashworth Scale and Fugl Meyer test will be used, respectively. Evaluations are performed after the first and last (fifth) session of electrical stimulation.
Participants/Inclusion and exclusion criteria
Chronic ischemic stroke patients who have at least six months since their injury and have spasticity level 1 or higher are included in the study.
Intervention groups
Intervention group: real stimulation of the primary motor area and Dorsolateral prefrontal cortex.
Main outcome variables
Motor function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211030052912N3
Registration date:2023-01-28, 1401/11/08
Registration timing:retrospective
Last update:2023-01-28, 1401/11/08
Update count:0
Registration date
2023-01-28, 1401/11/08
Registrant information
Name
Somaye Azarnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7173 2824
Email address
azarnia.pt.82@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-06, 1401/09/15
Expected recruitment end date
2023-01-10, 1401/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Unihemispheric Concurrent Dual-Site Transcranial Direct Current Stimulation of Dorsolateral Prefrontal Cortex AND primary motor cortex on improvement of lower limb motor function in patients with chronic stroke: A double-blind controlled clinical trial
Public title
Evaluation of the effect of Unihemispheric Concurrent Dual-Site Transcranial Direct Current Stimulation of Dorsolateral Prefrontal Cortex AND primary motor cortex on improvement of lower limb motor function in patients with chronic stroke: A double-blind controlled clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
First stroke
Medial Cerebellar Artery (MCA) stroke
The ability to verbally communicate with the therapist
Patients using the Ashworth Modified Modified Scale (MMAS) to have a knee flexion muscle spasm severity of 1 or higher
No history of a brain tumor
Patients who do not have severe cognitive and memory disorders. To determine this, the Persian version of the Mini-Mental State Examination is used and patients must score at least 23 out of a total of 30
Exclusion criteria:
Patients with chronic neurological diseases such as Parkinson's, Alzheimer's, schizophrenia, radiculopathy, and musculoskeletal disorders, especially upper extremity movement disorders, diagnosed by a neurologist.
History of seizures, previous brain surgery, heart disease and pacemaker
Take drugs that change a person's cognitive status
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
37
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done through Randomization.com. In this method, according to the two intervention groups (A) and control (B), 6 blocks of 4 will be determined. Each sequence is then recorded on a card and placed in an envelope. In order of patients' arrival, the envelopes are opened and the assigned group of the participant is determined. In this double-blind study, patients and evaluators are unaware of the type of group assigned. Randomization and intervention will be performed by a person who is not involved in the patient evaluation process and the evaluator is unaware of the type of intervention
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to protect patients 'personal information, patients' names and the type of study group are entered in a booklet along with a numeric code that has nothing to do with the national code or ID number, and all information in the computer and forms and analyzes are based on that numeric code. And the booklet will only be kept safe by the researcher and out of reach of others, and the information reported in the research will not be such that the identity of patients can be ascertained.
At the beginning of the implementation, all patients are informed that they may be in the intervention or control group, but will be unaware of this issue until the end of the project. After extracting the data, if the intervention is effective, the control group will be called and effective intervention for them. In addition to the patients, the person analyzing the MRS results (evaluator) is also unaware. Randomization and intervention will be performed by a person who is not involved in the patient evaluation process.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Guilan University of Medical Sciences
Street address
Namjoo avenue
City
Rasht
Province
Guilan
Postal code
13111-41937
Approval date
2022-11-09, 1401/08/18
Ethics committee reference number
ir.gums.rec.1401.408
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
G46
ICD-10 code description
Vascular syndromes of brain in cerebrovascular diseases
Primary outcomes
1
Description
Motor function
Timepoint
Before the first and after last electrical stimulation
Method of measurement
Fugl meyer test
2
Description
Brain metabolite activity,
Timepoint
Before the first and after last electrical stimulation
Method of measurement
Metabolite content with Magnetic resonance imaging
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Anodal stimulation of the M1 and DLPFC of the involved side. The two-channel device 2-NEUROSTIM manufactured by Medina Medical Company will be used to create electrical brain movements. The location of the electrodes will be determined using the international 10-20 system of electroencephalography. The location of the electrodes is determined using an international system of 10-20 electroencephalographs. The electrode pads are soaked in saline. Active electrodes according to the involved side, is left M1( c3) and DLPFC( F3) or right m1 (c4) and DLPFC ( F4 ) and reference electrodes will be placed on the contralateral of superorbital . Constant current with an intensity of 1 mA for 20 minutes with active electrode of 16 cm2 and a reference electrode of 35 cm2 will be used.The electrical stimulation will last for 5 sessions. After stimulating the patient, he will perform routine upper extremity exercises.
Category
Rehabilitation
2
Description
Control group: real M1 anal stimulation and sham DLPFC on the involved side. To generate brain electrical stimulations, the 2-NEUROSTIM two-channel device manufactured by Medina Tabgaster Company will be used. The location of the electrodes is determined using the international 10-20 electroencephalography system . The electrode pad is soaked in physiological serum solution. Active electrodes according to the involved side in the areas of the primary motor cortex equivalent to c3 and the posterior-lateral prefrontal cortex equivalent to F3 (in the left involvement) or the primary motor cortex equivalent to c4 and the posterior-lateral prefrontal cortex equivalent to F4 (right involvement) and reference electrodes on They will be placed on the supraorbital of the uninvolved side. A constant current with an intensity of 1 milliampere is applied for 20 minutes in a real way on the c3/c4 area and as a sham on the F3/F4 area. In order to localize the excitability of the motor cortex, the active electrode of 16 cm2 and the reference electrode of 35 cm2 will be used. Electrical stimulation will be for 5 sessions.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Pars hospital.rasht
Full name of responsible person
Somaye Azarnia
Street address
Pars Hospital, Shahid Gholipour Boulevard, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
4158813455
Phone
+98 13 3212 6173
Email
-info@pars-hospital.com
2
Recruitment center
Name of recruitment center
Persepolis physiotherapy
Full name of responsible person
Somaye Azarnia
Street address
Units 11 and 18, first floor,Dana doctors building, Golsar intersection, Rasht
City
Rasht
Province
Guilan
Postal code
4188866449
Phone
+98 13 3312 7211
Email
ez_kamran@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Heydar Ali Balu
Street address
Guilan University of Medical Sciences' Headquarters, Parastar St., Rasht
City
Rasht
Province
Guilan
Postal code
13111-41937
Phone
+98 13 3334 6489
Email
riasat@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Somaye Azarnia
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Guilan University of Medical Sciences' Headquarters, Parastar St., Rasht
City
Rasht
Province
Guilan
Postal code
13111-41937
Phone
+98 13 3334 6489
Email
azarnia.pt.82@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Azarnia Somaye
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No .10, Shahid Nazari Ave, Shahid Beheshti Blvd., Rasht
City
Rasht
Province
Guilan
Postal code
4188866449
Phone
+98 13 3360 5990
Email
azarnia.pt.82@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
somaye azarnia
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No .10, Shahid Nazari Ave, Shahid Beheshti Blvd., Rasht
City
Rasht
Province
Guilan
Postal code
4188866449
Phone
+98 13 3360 5990
Email
azarnia.pt.82@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
Confidentiality of data
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available