Evaluation of localization ability of stroke patients during synchronization of extracranial electrical stimulation and mechanical stimulation of fingers.
Observation of the effect of synchronized stimulation method (in the somatosensory region) on improving the tactile localization ability of post-stroke patients.
Design
The experiment is planned in such a way that the participant is blinded by a table and can not observe location of stimulation.
Settings and conduct
15 participants will receive 4 types of stimulation models as described in the intervention section. Due to the patient's hands under the table, the patient is not able to see the location of mechanical stimulation and can not clearly see the location of stimulation on his fingers. The location of the stimulus is detected only by the patient using the tactile sense system and the localization of tactile stimulation is evaluated using questions and answers from the subject about location of the mechanical stimulation.
Participants/Inclusion and exclusion criteria
Patient entry conditions:
1. Stroke patients who have lost some of their detection power.
2. Age range 24 to 70 years.
Conditions for non-entry of the patient:
1. The presence of metal objects such as implants, pacemakers, etc. in the patient's body.
2. weighing more than 100 kg.
3. Stroke patients who have the power of detection localization.
4. uncontrolled blood pressure.
Intervention groups
We have 4 intervention groups: 1- Mechanical (tactile) stimulation without electrical stimulation. 2- Mechanical stimulation and electrical stimulation of tDCS type to the primary somatosensory cortex of the patient's brain. 3- Mechanical stimulation and electrical stimulation of tDCS_sham type to the primary somatosensory cortex of the patient's brain. 4. Mechanical stimulation along with electrical stimulation of tDCS to the primary somatosensory cortex of the patient's brain, which we call tDSC-sync.
Main outcome variables
Synchronized electrical stimulation of brain regions in tactile functions.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210827052301N1
Registration date:2021-12-11, 1400/09/20
Registration timing:registered_while_recruiting
Last update:2021-12-11, 1400/09/20
Update count:0
Registration date
2021-12-11, 1400/09/20
Registrant information
Name
Maryam Ahmadi
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 41 5224 7414
Email address
mrymahmadi46@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-11, 1400/09/20
Expected recruitment end date
2022-01-29, 1400/11/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of localization ability of stroke patients during synchronization of extracranial electrical stimulation and mechanical stimulation of fingers.
Public title
Evaluation of localization ability of stroke patients during synchronization of extracranial electrical stimulation and mechanical stimulation of fingers.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Stroke patients.
Stroke patients who have lost some of their detection power.
Age range 24 to 70 years.
Lack of Tactile Localization.
Exclusion criteria:
The presence of metal objects such as implants, pacemakers, etc. in the patient's body.
weighing more than 100 kg.
Stroke patients who have localization.
uncontrolled blood pressure.
Age
From 24 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are completely blinded to the type of electrical stimulation and are unaware of the location of tactile stimulation or the type of electrical stimulation. To blind the participant, his hand is placed under a table so that he cannot see the location of tactile stimulation.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University Of Medical Sciences
Street address
Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-02-25, 1398/12/06
Ethics committee reference number
IR.IUMS.REC.1398.1222
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
G46.3
ICD-10 code description
Brain stem stroke syndrome
Primary outcomes
1
Description
The main outcome variable in this study is synchronized electrical stimulation of brain regions in tactile localization.
Timepoint
The effect of synchronized electrical stimulation of brain areas in tactile localization is measured during experiment.
Method of measurement
The experiment is planned in such a way that the participant is blinded by a table and can not observe location of stimulation. In this case, the patient is asked to identify the location of stimulation. Based on this, the number of times the patient correctly identified the location of stimulation is counted.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In this group, both mechanical and electrical stimulation of the tDCS type will be applied to the primary somatosensory cortex of the patient's brain.
Category
Treatment - Devices
2
Description
Intervention group 2: In this group, both mechanical and electrical stimulation of tDCS_sham type will be applied to the primary somatosensory cortex of the patient's brain.
Category
Treatment - Devices
3
Description
Intervention group 3: In this group, both mechanical stimulation and electrical stimulation of tDCS type will be applied to the primary somatosensory cortex of the patient's brain, this case is similar to the previous case, except that each time mechanical stimulation is applied, electrical stimulation will be applied and electrical stimulation will be interrupted when mechanical stimulation is stopped. In other words, electrical stimulation will be synchronized with mechanical stimulation, which we call tDSC-sync.
Category
Treatment - Devices
4
Description
Intervention group 4: In this group, only mechanical (tactile) stimulation will be applied and no electrical stimulation will be applied.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Firouzgar Hospital
Full name of responsible person
Maryam Ahmadi
Street address
Behafarin street ,Karimkhan street, Valiast Blvr.
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3904
Email
mrymahmadi46@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mohammad Rostami
Street address
Jalal Al Ahmad highway
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3904
Email
m-rostami@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Project Manager of Simulation Systems Laboratory.
Proportion provided by this source
100
Public or private sector
Private
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
The University of Tarbiat Modares
Full name of responsible person
Mohammad Rostami
Position
senior researcher
Latest degree
Master
Other areas of specialty/work
Neuroscience
Street address
Jalal al ahmad street
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3904
Email
m-rostami@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Tarbiat Modares
Full name of responsible person
Dr Zahra Bahmani Dehkordi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Jalal al ahmad highway
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3904
Email
zabahmani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Tarbiat Modares
Full name of responsible person
Maryam Ahmad
Position
researcher
Latest degree
Bachelor
Other areas of specialty/work
Neuroscience
Street address
Jalal al Ahmad highway
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3904
Email
mrymahmadi46@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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