Effect of Repetitive Transcranial Magnetic Stimulation over the supplementary motor area and dorsolateral prefrontal cortex in improvement of gait in Parkinson’s disease
Conducting research to replace drug therapy with a safe intervention (rTMS) to improve walking and movement problems in patients with Parkinson's disease.
Design
A clinical trial with a control group - double-blind - randomized - on 21 patients - rand function of Excel software was used for randomization
Settings and conduct
The place of study is in the research center clinic of Semnan University of Medical Sciences
The method of doing the work is that the patients are divided into 3 groups (2 intervention groups and 1 control group), in one intervention group, rTMS intervention is applied on the SMA cortices and in the other group on the DLPFC area, and in the control group, a silent device is applied on the heads of patients with Parkinson's to get visual and sensory feedback. and the evaluation is done by the three dimensional motion analysis device before and after the intervention and in the 1-month follow-up and the results are analyzed
The study is double-blind, so that patients and clinical caregivers are blinded
Participants/Inclusion and exclusion criteria
People with Parkinson's who know the ability to walk independently are included in this study, and people with a history of cerebral hemorrhage or cerebral plaque and a history of epilepsy should not be included in the study.
Intervention groups
The rTMS device intervention is in 2 treatment groups, and in the control group, we turn off the device and place it on the patient's head so that the patient receives visual and sensory feedback for the treatment.
Main outcome variables
Examining walking parameters such as joint angles in the hip, knee and ankle joints and the force exerted by the foot when putting weight on each foot
General information
Reason for update
Acronym
EROSDIGPD
IRCT registration information
IRCT registration number:IRCT20230125057225N1
Registration date:2023-02-01, 1401/11/12
Registration timing:prospective
Last update:2023-02-01, 1401/11/12
Update count:0
Registration date
2023-02-01, 1401/11/12
Registrant information
Name
Ali Heidarinejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4494 4265
Email address
aliheidarinejad7444@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-09, 1401/11/20
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Repetitive Transcranial Magnetic Stimulation over the supplementary motor area and dorsolateral prefrontal cortex in improvement of gait in Parkinson’s disease
Public title
Effect of rTMS device in improving walking in patients with Parkinson's disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with advanced Parkinson's (patients who are in advanced stages often have movement problems - incontinence - insomnia and dementia)
People with Parkinson's disease have freezing of gait (FOG).
People with Parkinson's who take L-Dopa
People who are over 45 years old (according to the opinion of the neurologist who advised the article)
The patient should be able to walk without crutches
Exclusion criteria:
Associated painful conditions that may distort the clinical picture of the study
People who have a history of epilepsy and have a history of taking antiepileptic drugs such as benzodiazepines.
People with a history of cerebral hemorrhage
People who have problems such as brain aneurysm or brain plaque
People with dementia
Based on the Bech questionnaire, patients with major depression are excluded from the study
Age
From 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
21
More than 1 sample in each individual
Number of samples in each individual:
1
Each example is a Parkinson's patient with the ability to walk without crutches and the assistance of others
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method
Randomization unit: individual
Randomization tool: sealed envelope
We write the numbers 1 to 21 on each paper and then each envelope is assigned to one person by lottery, and the numbers 1-4-7...are assigned to the first group, and the numbers 8-2-5-8...are assigned to the second group, and the numbers 9-3-6... They belong to the third group
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients in the study are blinded and do not know which group they are in. In the 2 treatment groups, the device is turned on, and in the control group, the device is turned off during rTMS application.
The clinical caregiver is also blind in the study because he does not know about our grouping and he is only told for which patients to turn on the device and for which patients to turn off the device.
Placebo
Used
Assignment
Other
Other design features
In the study, we have 3 groups in which the same treatment (rTMS) is applied in 2 groups and we have a control group in which the rTMS device is applied off.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Semnan University of Medical Sciences
Street address
West Ferdous Blvd., Bahrashmali St., West Manochehri St., 1 Acacia Alley, No. 13, Zang 8
City
Tehran
Province
Tehran
Postal code
1484765733
Approval date
2023-01-24, 1401/11/04
Ethics committee reference number
IR.SEMUMS.REC.1401.255
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
1- The variable of hip-knee-ankle joint movement angles which is measured by the motion device
Timepoint
Before starting the intervention - the end of 10 treatment sessions -1month follow-up
Method of measurement
three dimensional motion analysis device
2
Description
The variable of the movement score which is measured by the UPDRS-part 3 questionnaire
Timepoint
Before starting the intervention - the end of 10 treatment sessions -1month follow-up
Method of measurement
Questionnaire UPDRS-part 3
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The intervention is by rTMS device made by Madinatab Iran company and the evaluation is done by three dimensional motion analysis device and by Qualysis software and the intervention by rTMS device is in the form of 10 therapy sessions (3 sessions per week and 4 sessions at the end of the week) which is applied in the SMA group with a frequency of 10Hz in the M1 area with a pulse count of 2000 and a resting motor threshold intensity of 90%.
Category
Rehabilitation
2
Description
Intervention group:The intervention is by rTMS device made by Madinatab Iran and the evaluation is done by three dimensional motion analysis device and Qualysis software and the intervention by rTMS device is 10 treatment sessions (3 sessions per week and 4 sessions at the end of the week) which is applied in the DLPFC group with a frequency of 10 Hz in the F3 area with a pulse count of 2000 and a resting motor threshold intensity of 90%.
Category
Rehabilitation
3
Description
Control group: In the control group, the rTMS device is placed silently on the patients' heads so that the patients can use the visual and sensory feedback to receive the placebo treatment, and the patients' gait is evaluated before and after and as a 1-month follow-up by a three-dimensional motion analysis device and by the Qualysis software.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Semnan University of Medical Sciences Research Center Clinic
Full name of responsible person
Majid Mirmohammadkhani
Street address
Mashahir Square towards Saadi Square, Research Center Clinic
City
Semnan
Province
Semnan
Postal code
3519698375
Phone
+98 23 3332 8502
Email
majidmirmohammadkhani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mirmohammadkhani
Street address
Mashahir Square towards Saadi Square, Research Center Clinic
City
Semnan
Province
Semnan
Postal code
3519698375
Phone
+98 23 3332 8502
Email
majidmirmohammadkhani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Ali Heidarinejad
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Ferdous Blvd, west of North Bahar St., West Manouchehri St., 1 Acacia Alley, No. 13, Zang 8
City
Tehran
Province
Tehran
Postal code
1484765733
Phone
+98 21 4494 4265
Email
aliheidarinejad7444@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali heidarinejad
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Ferdous Blvd, west of North Bahar St., West Manochehri St., 1 Acacia Alley, No. 13, Zang 8
City
Tehran
Province
Tehran
Postal code
1484765733
Phone
0092144944265
Email
aliheidarinejad7444@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Heidarinejad
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Ferdous Blvd, west of North Bahar St., West Manouchehri St., 1 Acacia Alley, No. 13, Zang 8
City
Tehran
Province
Tehran
Postal code
1484765733
Phone
+98 21 4494 4265
Email
aliheidarinejad7444@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Yes - There is 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
People's information, including age and gender, can be published, but the names of people cannot be published
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Data must be used confidentially
From where data/document is obtainable
aliheidarinejad7444@gmail.com
Ali heidarinejad
00989129345778
What processes are involved for a request to access data/document
After giving an email or a phone call to the mentioned phone number, the documents will reach her within 3 weeks