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Intervention groups
#1
Intervention group: 6 PSP patients who receive 10 sessions of rTMS with 900 daily pulses of 1 Hz. The location of the coils will be in contact with the skull two centimeters on the sides and one centimeter below the inion
Intervention group: 6 PSP patients who receive 10 sessions of rTMS with 900 daily pulses of 10 Hz every other day. The location of the coils will be in contact with the skull two centimeters on the sides and one centimeter below the inion
Intervention group: 6 PSP patients who receive 10 sessions of rTMS with 900 daily pulses of 110 Hz every other day. The location of the coils will be in contact with the skull two centimeters on the sides and one centimeter below the inion
گروه مداخله: 6 بیمار PSP که 10 جلسه rTMS با 900 پالس روزانه ی 1 هرتزی دریافت میکنندمحل کویل ها در تماس با جمجمه دو سانت در طرفین و یک سانتیمتر پایین inion خواهد بود .
گروه مداخله: 6 بیمار PSP که 10 جلسه rTMS با 900 پالس روزانه ی 10هرتزی بصورت روز درميان دریافت میکنندمحل کویل ها در تماس با جمجمه دو سانت در طرفین و یک سانتیمتر پایین inion خواهد بود .
گروه مداخله: 6 بیمار PSP که 10 جلسه rTMS با 900 پالس روزانه ی 1 هرتزی10هرتزی بصورت روز درميان دریافت میکنندمحل کویل ها در تماس با جمجمه دو سانت در طرفین و یک سانتیمتر پایین inion خواهد بود .
#2
Control group: 6 PSP patients who receive 10 sessions of rTMS along with a 3 cm non-conductive object between the scalp and the cap of the device and 900 daily pulses of 1 Hz. The location of the coils will be in contact with the skull two centimeters on the sides and one centimeter below the inion.
Control group: 6 PSP patients who receive 10 sessions of rTMS every other day ,along with a 3 cm non-conductive object between the scalp and the cap of the device and 900 daily pulses of 10 Hz. The location of the coils will be in contact with the skull two centimeters on the sides and one centimeter below the inion.
Control group: 6 PSP patients who receive 10 sessions of rTMS every other day ,along with a 3 cm non-conductive object between the scalp and the cap of the device and 900 daily pulses of 110 Hz. The location of the coils will be in contact with the skull two centimeters on the sides and one centimeter below the inion.
گروه کنترل: 6 بیمار PSP که 10 جلسه rTMS بوسیله ی جسم ناراسانای 3 سانتی متری بین پوست سر و کلاهک دستگاه وبا 900 پالس روزانه ی 1 هرتزی دریافت میکنندمحل کویل ها در تماس با جمجمه دو سانت در طرفین و یک سانتیمتر پایین inion خواهد بود .
گروه کنترل: 6 بیمار PSP که 10 جلسه بصورت روز درميان rTMS بوسیله ی جسم ناراسانای 3 سانتی متری بین پوست سر و کلاهک دستگاه وبا 900 پالس روزانه ی ١٠ هرتزی دریافت میکنند،محل کویل ها در تماس با جمجمه دو سانت در طرفین و یک سانتیمتر پایین inion خواهد بود .
گروه کنترل: 6 بیمار PSP که 10 جلسه بصورت روز درميان rTMS بوسیله ی جسم ناراسانای 3 سانتی متری بین پوست سر و کلاهک دستگاه وبا 900 پالس روزانه ی 1١٠ هرتزی دریافت میکنندمحلمیکنند،محل کویل ها در تماس با جمجمه دو سانت در طرفین و یک سانتیمتر پایین inion خواهد بود .
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: dr. ghayoor-e-mobarhan
Full name of responsible person - Persian: دکتر غیور مبرهن
Street address - English: Unit 303,Third Floor,Eastern Wing, Tower G, Tower G4,before Kharazi Highway,, Northern Pazhouhesh Blvd,Chitgar ,Tehran
Street address - Persian: تهران٬چیتگر٬بلوار پژوهش شمالی٬قبل از اتوبان خرازی٬برجهای g ٬برج G4 ٬بال شرقی ٬طبقه ی سوم واحد 303
City - English: mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 1496960720
Phone: +98 912 763 5742
Fax:
Email: m.farahnezhad@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: dr. Ghayoor-e-mobarhan
Full name of responsible person - Persian: دکتر غیور مبرهن
Street address - English: Research and Technology Vice-Chancellor, Qorshi Building, next to Hoizeh Cinema, University Street,Mashhad
Street address - Persian: مشهد، خیابان دانشگاه- جنب سینما هویزه- ساختمان قرشی- معاونت پژوهش و فناوری
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 1496960720
Phone: +98 51 3841 1538
Fax:
Email: ghayourm@mums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: dr. ghayoorGhayoor-e-mobarhan Full name of responsible person - Persian: دکتر غیور مبرهن Street address - English: Unit 303,Third Floor,Eastern WingResearch and Technology Vice-Chancellor, Tower GQorshi Building, Tower G4,before Kharazi Highway,next to Hoizeh Cinema, Northern Pazhouhesh Blvd,Chitgar ,TehranUniversity Street,Mashhad Street address - Persian: تهران٬چیتگر٬بلوارمشهد، خیابان دانشگاه- جنب سینما هویزه- ساختمان قرشی- معاونت پژوهش شمالی٬قبل از اتوبان خرازی٬برجهای g ٬برج G4 ٬بال شرقی ٬طبقه ی سوم واحد 303و فناوری City - English: mashhadMashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 1496960720 Phone: +98 912 763 574251 3841 1538 Fax: Email: m.farahnezhadghayourm@yahoo.commums.ac.ir Web page address:
Protocol summary
Study aim
we aim to measure the effect of rTMS on dysarthria and postural disturbance in patients with PSP in Mashhad on 2023
Design
clinical trial with intervention and sham groups,parallel,triple blind ,randomized,in phase 2-3 design on 12 PSP patients,enrolled in may and jun 2023 and followed for 4 months
Settings and conduct
12 PSP patients were first scored for movement (by motion kinematics analysis) and speech and swallowing (scoring by speech therapist) from patients diagnosed with PSP who were chosen from the movement disorders clinic . The place of rTMS is the psychiatry clinic, the speech and swallowing evaluation place will be the speech therapy clinic ,the balance analysis place will be in the physiotherapy clinic. The patients are then randomly and blindly divided into intervention and sham groups and receive 10 sessions of rTMS every other day (in the sham group, a three cm nonconductor piece is placed between the cap of the device and the scalp) blinding of the patients and the researchers is done by sealed letters that contain codes determined based on permutation blocks.
Participants/Inclusion and exclusion criteria
the patients who have PSP diagnosis that have ability for walking a few steps and speaking in a few words but they don't have previous dysarthria ,properioception or vesttibular sensory disorders and stroke and also who don't have rTms containdications
Intervention groups
rTms is done by two magsim 200 that is connectedto 2 groups of flat coils and the intensity of produced MEP is until 1mV. the coil sites in contact with skullis 2 cm in laterals and 1 cm below the inion.
Main outcome variables
postural disturbance with motion analysis and kinematic analysis of movement and scoring based on the calculation of the result of the measured forces;state of dysarthria and swallowing with the Pietrenberg auditory-perceptual evaluation index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230504058069N1
Registration date:2023-06-18, 1402/03/28
Registration timing:retrospective
Last update:2023-06-27, 1402/04/06
Update count:1
Registration date
2023-06-18, 1402/03/28
Registrant information
Name
Mina FarahNejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 763 5742
Email address
m.farahnezhad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-26, 1402/03/05
Expected recruitment end date
2023-06-05, 1402/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of repetitive transcranial magnetic stimulation on dysarthria and postural disturbance in patients with progressive supranuclear palsy
Public title
ًRTMS effects on PSP patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
PSP patients that was diagnosed by national institute of neurologic disease and stroke for PSP citeria
patient who can stand alon and without helping
patient who can walking at least a few steps without helping
patient who can speak and answer the questions
patient who has signed the informed consent form to enter the plan
Exclusion criteria:
patient who was diagnosed dementia by DSM-IV criteria
patient who had vestibular or properioception or sensory deficits
patient who has any contraindication of brain stimulation (such as pacemakers or presence of metal objects in the head)
the patient had dysartheria before the onset of disease
patient who had past medical history of stroke
patient who is mute
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
12
Randomization (investigator's opinion)
Randomized
Randomization description
there was used randominaztion techniques by blocks for patients' groups randominazation, for this purpose we must make a block by 30 charachters with combination of A ,B alphabet in "sealed envelope" site and use it for randominazation.
we use allocation concealment by sealed envelops
Blinding (investigator's opinion)
Double blinded
Blinding description
blinding was done in participant patients,investigators and outcome assesors.patients and investigators by using a secret code in the selead envelopes remain blinded and information analizer is chosen from out of researcher group
Intervention patient (receive RTMS or sham) in sealed envelopes that code
are received. Coding by one of the project collaborators
It takes place and the doctor, evaluator and patient are blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committees of school of medicine-Mashhad university of medical sciences
Street address
Research and Technology Vice-Chancellor, Qurashi Building, next to Hoize Cinema,University St.,Mashhad
The beginning of the study (before starting rTMS), the end of receiving rTMS, four months later
Method of measurement
Kinematic analysis of scoring movement based on the results of forces and energy
2
Description
Checking the speech and swalling of patients
Timepoint
The beginning of the study (before starting rTMS), the end of receiving rTMS, four months later
Method of measurement
Wanberg's auditory-perceptual assessment index and the Northwestern swallowing disorder test
Secondary outcomes
1
Description
کیفیت زندگی بیماران
Timepoint
The beginning of the study and the end of the study
Method of measurement
PDQL questionnaire
Intervention groups
1
Description
Intervention group: 6 PSP patients who receive 10 sessions of rTMS with 900 daily pulses of 10 Hz every other day. The location of the coils will be in contact with the skull two centimeters on the sides and one centimeter below the inion
Category
Rehabilitation
2
Description
Control group: 6 PSP patients who receive 10 sessions of rTMS every other day ,along with a 3 cm non-conductive object between the scalp and the cap of the device and 900 daily pulses of 10 Hz. The location of the coils will be in contact with the skull two centimeters on the sides and one centimeter below the inion.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of movement disorders, the office of the first executive of the study
Full name of responsible person
Mina FarahNezhad
Street address
unit 303, third floor, east wing, G4 tower,g towers, before Kharazi highway,, Northern Research Blvd.,Chitgar,Tehran
City
Mashhad
Province
Razavi Khorasan
Postal code
1496960720
Phone
+98 912 763 5742
Email
m.farahnezhad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
dr. Ghayoor-e-mobarhan
Street address
Research and Technology Vice-Chancellor, Qorshi Building, next to Hoizeh Cinema, University Street,Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
1496960720
Phone
+98 51 3841 1538
Email
ghayourm@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mina FarahNezhad
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Unit 303,Eastern Wing, Third Floor,Tower G, Tower G4,before Kharazi Highway,Northern Pazhouhesh Blvd,Chitgar,Tehran
City
mashhad
Province
Razavi Khorasan
Postal code
1496960720
Phone
+98 912 763 5742
Email
m.farahnezhad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
mina farahnezhad
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Unit 303, Third Floor,Eastern Wing,Tower G4,G Towers,before Kharazi Highway,Northern pazhouhesh Blvd.,Chitgar,Tehran
City
mashhad
Province
Razavi Khorasan
Postal code
1496960720
Phone
+98 912 763 5742
Email
m.farahnezhad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mina FarahNezhad
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Unit 303, Third Floor,Eastern Wing,Tower G4,G Towers,before Kharazi Highway,Northern pazhouhesh Blvd.,Chitgar,Tehran
City
mashhad
Province
Razavi Khorasan
Postal code
1496960720
Phone
+98 912 763 5742
Email
m.farahnezhad@yahoo.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
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All the potential data of movement score and questionnaires and speech and swallowing scores of patients can be shared after making them non-identifiable
When the data will become available and for how long
Access starts 6 months to a year after publication
To whom data/document is available
only available for people working in academic institutions
Under which criteria data/document could be used
It is possible to use the documents of this research only by mentioning the names of its researchers in articles and academic researches.
From where data/document is obtainable
from responsible author: Mina Farah Nejad
Email: m.farahnezhad@yahoo.com and farahnezhadm991@mums.ac.ir
Phone number: 00989127635742
What processes are involved for a request to access data/document
After requesting to receive the research documents by the researcher's academic email and after explaining about the research and the reason for the need of the desired documents by sending to the responsible author's email, if accepted, it will be sent within 1 month at the latest