The Effect of Unihemispheric Concurrent Dual-Site Transcranial Direct Current Stimulation of Primary Motor and Dorsolateral Prefrontal Cortices on cerebral plasticity (with magnetic resonance spectroscopy) in Patients With chronic Stroke: A double-blind controlled clinical trial
Evaluation of the effect of a-tDCSUHCDS (M1-DLPFC) treatment on neuroplasty in patients with chronic stroke.
Design
Clinical trial with a two-way blind randomized control group
Settings and conduct
By referring to Pars Hospital in Rasht, after examining patients with stroke, a neurologist will provide the necessary explanations about the study objectives and its implementation method for people who have entry criteria, and if agreed, the consent form will be provided. They sign the letter. The candidate is assured that they can refuse to cooperate at any stage of the investigation and that all personal and medical information remains confidential. After obtaining informed consent, a comprehensive questionnaire containing personal information and illness will be completed and then the cognitive status will be assessed by MMSE test. Then, MRS participants will be taken to examine brain metabolites.
Participants/Inclusion and exclusion criteria
Stroke patients who have had a lesion for at least six months
Intervention groups
Intervention: Real stimulation of the primary motor area and the Dorsolateral prefrontal cortex
Control: Real stimulation of the primary motor area and sham stimulation of the Dorsolateral prefrontal cortex
Main outcome variables
Brain metabolite activity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211030052912N2
Registration date:2021-11-13, 1400/08/22
Registration timing:prospective
Last update:2021-11-13, 1400/08/22
Update count:0
Registration date
2021-11-13, 1400/08/22
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
2021-11-29, 1400/09/08
Expected recruitment end date
2022-04-22, 1401/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Unihemispheric Concurrent Dual-Site Transcranial Direct Current Stimulation of Primary Motor and Dorsolateral Prefrontal Cortices on cerebral plasticity (with magnetic resonance spectroscopy) in Patients With chronic Stroke: A double-blind controlled clinical trial
Public title
The Effect of Unihemispheric Concurrent Dual-Site Transcranial Direct Current Stimulation of Primary Motor and Dorsolateral Prefrontal Cortices on cerebral plasticity (with magnetic resonance spectroscopy) in Patients With chronic Stroke: A double-blind controlled clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
First ischemic stroke
MCA stroke
At least 6 months have passed since the stroke
Patients with chronic neurological diseases such as Parkinson's, Alzheimer's, schizophrenia, radiculopathy, and musculoskeletal disorders, especially upper extremity movement disorders, are not diagnosed by a neurologist
No history of brain tumor
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 with 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:
Lack of patient cooperation for post-intervention tests
. People who withdraw from the research for any reason and do not want to continue the research.
Severe fatigue so that the person is unable to continue the test
Sensitivity of the patient's scalp to stimuluse
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
22
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 University of Rehabilitation Sciences and Social Health
Vascular syndromes of brain in cerebrovascular diseases
Primary outcomes
1
Description
Brain metabolite activity
Timepoint
Before and after the first electrical stimulation
Method of measurement
Metabolite content based on PPM with MRI
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. 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
Treatment - Other
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
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Pars hospital.rasht
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
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamid Reza Khorram Khorshid
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
50
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