Evaluation of the effect of adding direct transcranial stimulation (tDCS) of Dorsolateral Prefrontal Cortex to primary motor cortex on spasticity and improvement of upper limb motor function in patients with chronic stroke: A double-blind controlled clinical trial
Evaluation of the effect of adding direct transcranial stimulation (tDCS) of Dorsolateral Prefrontal Cortex to primary motor cortex on spasticity and improvement of upper limb motor function in patients with chronic stroke
Design
A clinical trial with a double-blind randomized control group on 42 patients, using Randomization site for randomization.
Settings and conduct
By referring to the hospitals of Rasht city, after examining the patients with stroke, the neurologist will provide the necessary explanations about the study objectives and the method of its implementation for the people who meet the entry criteria. Then, if they agree to participate. Consciously and voluntarily in the research, they sign the consent form. After obtaining informed consent, the questionnaire of personal information and disease will be completed and then the cognitive status will be done with MMSE test. Then, in order to measure the severity of spasticity of patients' flexor wrist muscles and functional status, the Persian version of the MMAS and FM test will be used, respectively. Evaluations are performed after the first and last (fifth) session of electrical stimulation.
Participants/Inclusion and exclusion criteria
Patients with chronic ischemic stroke who have been injured for at least six months are included in the study. The severity of spasticity 1 and higher and the ability to understand and communicate verbally are other conditions for inclusion in the study. If the patient is allergic to cranial stimulation or does not want to cooperate, will be excluded from the study.
Intervention groups
Intervention group: real stimulation of the primary motor area and Dorsolateral prefrontal cortex.
Control group: real stimulation of the primary motor area and sham stimulation of Dorsolateral prefrontal cortex.
Main outcome variables
Motor function, spasticity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211030052912N1
Registration date:2021-11-11, 1400/08/20
Registration timing:prospective
Last update:2021-11-11, 1400/08/20
Update count:0
Registration date
2021-11-11, 1400/08/20
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
2021-12-19, 1400/09/28
Expected recruitment end date
2022-05-10, 1401/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of adding direct transcranial stimulation (tDCS) of Dorsolateral Prefrontal Cortex to primary motor cortex on spasticity and improvement of upper limb motor function in patients with chronic stroke: A double-blind controlled clinical trial
Public title
Evaluation of the effect of adding direct transcranial stimulation (tDCS) of Dorsolateral Prefrontal Cortex to primary motor cortex on spasticity and improvement of upper limb motor function in patients with chronic stroke: A double-blind controlled clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
First ischemic stroke صاهزا At least 6 months have passed since the stroke
MCA stroke
Patients using the ashworth Modified Modified Scale (MMAS) to have a wrist flexion muscle spasm severity of 1 or higher
Patients without chronic neurological diseases such as Parkinson's, Alzheimer's, schizophrenia, radiculopathy, and musculoskeletal disorders, especially upper extremity movement disorders, diagnosed by a neurologist
Ability to communicate verbally with the therapist
Do not take drugs that change a person's cognitive status
No heart disease and pacemaker, No history of seizures, previous brain surgery
Patients without severe cognitive and memory impairment. To determine this, the Persian version of MMSE is used and patients must obtain a minimum score of 23 out of a total of 30 points.
Exclusion criteria:
Hemorrhagic stroke patients
Stroke patients with arterial injury other than the middle cerebral artery
Patients with lacunar stroke
Patients with acute and subacute ischemic stroke
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done through Randomization.com. According to the two intervention groups (A) and control (B), six Quadriple blocks will be used in this method. 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.
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the University of Rehabilitation Sciences and Social Health
Street address
Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2021-10-20, 1400/07/28
Ethics committee reference number
IR.USWR.REC.1400.185
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I67
ICD-10 code description
Other cerebrovascular diseases
Primary outcomes
1
Description
Motor function
Timepoint
Upon entering the study, after the first and last session of stimulation
Method of measurement
Fugl meyer test
2
Description
Spasticity
Timepoint
Upon entering the study, after the first and last session of stimulation
Method of measurement
Modified Modified Ashworth Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Anodal stimulation of the M1 and pDLPFC of the involved side. To create electrical brain movements, 2 devices of a tDCS channel, model Activados, made in the USA will be used. 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.
Category
Rehabilitation
2
Description
Control group: Real anodal stimulation of the primary motor cortex and sham stimulation of the Dorsolateral prefrontal cortex involved side. To create electrical stimulation of the brain, two single-channel devices tDCS model Activodos made in the United States will be used. 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 superorbital of contralateral side. A constant current of 1 mA is applied to the M1 region for 20 minutes. Stimulation in theDorsolateral prefrontal cortex is extinguished with the same intensity after 30 seconds. In order to localize the excitability of the motor cortex, an active electrode of 16 cm2 and a reference electrode of 35 cm2 will be used.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Porsina hospital
Full name of responsible person
Somaye Azarnia
Street address
Namjoo
City
Rasht
Province
Guilan
Postal code
000000
Phone
+98 13 3362 1657
Email
azarnia.pt.82@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Somaye Azarnia
Street address
Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2000
Email
azarnia.pt.82@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
Proportion provided by this source
70
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
University of social welfare and rehabilitation sciences
Full name of responsible person
Somaye azarnia
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
71732000
Email
azarnia.pt.82@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Somaye azarnia
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
71732000
Email
azarnia.pt.82@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Somaye azarnia
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
71732000
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
Data confidentiality
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