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Visual-spatial attention and risk decision making of Parkinson's disease Patients in Comparison with healthy individuals and the effect of deep brain stimulation on it

Protocol summary

Study aim
The effect of deep brain stimulation surgery on cognitive disorders in patients with Parkinson's
Design
This study includes a study on three groups of participants who are selected non-randomly and in a controlled manner: 1 Experimental group: Patients with Parkinson's candidate for deep brain stimulation surgery, 2 Control group : Patients with Parkinson's without the need for deep brain stimulation surgery, 3 Second control group: healthy people without Parkinson's disease and neurodegenerative diseases, All three groups are selectively and non-randomly placed in the desired groups. We will have a sample size of 12 people in each group and a total of 36 cases. Clinical trial has two control groups, with parallel, non-random groups.
Settings and conduct
Imam Reza Clinic of Shiraz , Namazi Hospital of Shiraz and Kosar Hospital of Shiraz How to implement and select study cases will be done at the discretion and opinion of the consultant (neurologist).
Participants/Inclusion and exclusion criteria
All patients with Parkinson's are diagnosed by a neurologist, Have a minimum literacy, Satisfaction with participation in research, No neurodegenerative disease other than Parkinson's disease, Minimum age 15 years
Intervention groups
We include Parkinson's patients who, according to a neurologist, are candidates for deep brain stimulation surgery, in the experimental group, and Parkinson's patients, who do not need to undergo deep brain stimulation surgery at least until the end of the study.
Main outcome variables
Cognitive function, especially spatial visual attention and their level of risk

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220227054136N1
Registration date: 2022-03-21, 1401/01/01
Registration timing: registered_while_recruiting

Last update: 2022-03-21, 1401/01/01
Update count: 0
Registration date
2022-03-21, 1401/01/01
Registrant information
Name
Mahshad Sohrabi jahromi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5444 9616
Email address
m.sohrabi1374@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-11, 1400/12/20
Expected recruitment end date
2022-11-11, 1401/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Visual-spatial attention and risk decision making of Parkinson's disease Patients in Comparison with healthy individuals and the effect of deep brain stimulation on it
Public title
The effect of deep brain stimulation on cognitive disorders in Parkinson's disease patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
all Parkinson's disease patients Persons with a minimum age of 15 years Minimum literacy
Exclusion criteria:
People with neurodegenerative diseases except for Parkinson's patients Inability to perform tests for any reason Dissatisfaction with participation in research
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
4 Tavakoli, N Edalat street
City
Shiraz
Province
Fars
Postal code
7168637502
Approval date
2022-02-01, 1400/11/12
Ethics committee reference number
IR.SUMS.REC.1400.846

Health conditions studied

1

Description of health condition studied
parkinson,s disease
ICD-10 code
G20
ICD-10 code description
Parkinson's disease

Primary outcomes

1

Description
Spatial visual attention scores in the Simon task
Timepoint
First pre-test about 20 to 10 days before surgery, second pre-test about 3 to 1 day before surgery, first post-test 1 to 7 days after surgery, second post-test about 40 days after surgery, third post-test about 3 Month after surgery
Method of measurement
simon task

2

Description
Risk ratings in the Cambridge Risk Task have been modified
Timepoint
First pre-test about 20 to 10 days before surgery, second pre-test about 3 to 1 day before surgery, first post-test 1 to 7 days after surgery, second post-test about 40 days after surgery, third post-test about 3 Month after surgery
Method of measurement
Modified Cambridge Risk Task

Secondary outcomes

empty

Intervention groups

1

Description
Control group 1 : This group includes Parkinson's patients without the need for deep brain stimulation surgery and no therapeutic interventions are performed on them.
Category
Behavior

2

Description
Control group 2 : This group includes healthy people without Parkinson's disease and no therapeutic intervention is performed on them.
Category
Behavior

3

Description
Intervention group: Parkinson's patients are candidates for deep brain stimulation surgery performed by a surgical intervention surgeon.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Clinic
Full name of responsible person
Mahshad Sohrabi Jahromi
Street address
Imam Reza Clinic , Zand Boulevard , shiraz, fars
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3612 1000
Fax
+98 71 3647 4673
Email
motahari@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kordestan university
Full name of responsible person
Dr. Ahmad Sohrabi
Street address
Kordestan university, Pasdaran boulevard, Sanandaj , Iran
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3366 4600
Email
info@uok.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
cognitive sciences and technologies council
Proportion provided by this source
40
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
The University of Kordestan
Full name of responsible person
Mahshad Sohrabi Jahromi
Position
University student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Tavakoli4 , N Edalat Blvd , Shiraz
City
Shiraz
Province
Fars
Postal code
7168637502
Phone
+98 71 5444 9616
Email
m.sohrabi1374@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Kordestan
Full name of responsible person
Dr. Ahmad Sohrabi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
The University of Kordestan , Pasdaran Blvd , Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Phone
+98 87 3366 4600
Email
sohrabya@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Kordestan
Full name of responsible person
Mahshad Sohrabi Jahromi
Position
University Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Tavakoli 4 , N Edalat Blvd , Shiraz
City
Shiraz
Province
Fars
Postal code
7168637502
Phone
+98 71 5444 9616
Email
m.sohrabi1374@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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Not all information about the participants in the study will be available and only part of it related to the results will be available.
When the data will become available and for how long
The data access period will start approximately one year after the results are published.
To whom data/document is available
All researchers whose field of study is the prevention, diagnosis and treatment of neurodegenerative patients will have access to information.
Under which criteria data/document could be used
They are allowed to apply if non-governmental or private centers decide to take measures for the well-being and rehabilitation of patients or their caregivers and need part of the results.
From where data/document is obtainable
Mahshad Sohrabi Jahromi m.sohrabi1374@gmail.com Dr. Ahmad Sohrabi sohrabya@gmail.com
What processes are involved for a request to access data/document
Provide credible evidence that the researcher is in the field of neurodegenerative patients or provide credible evidence that a particular organization or industry will take action for the well-being of these patients or their caregivers.
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