Protocol summary
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Study aim
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we aim to measure the effect of rTMS on dysarthria and postural disturbance in patients with PSP in Mashhad on 2023
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Design
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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
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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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
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2023-06-18, 1402/03/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-05-26, 1402/03/05
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Expected recruitment end date
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2023-06-05, 1402/03/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of repetitive transcranial magnetic stimulation on dysarthria and postural disturbance in patients with progressive supranuclear palsy
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Public title
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ًRTMS effects on PSP patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
12
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-11-08, 1401/08/17
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Ethics committee reference number
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IR.MUMS.MEDICAL.REC.1401.663
Health conditions studied
1
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Description of health condition studied
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PSP Proressive supranuclear palsy
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ICD-10 code
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G23.1
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ICD-10 code description
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Progressive supranuclear ophthalmoplegia [Steele-Richardson-Olszewski]
Primary outcomes
1
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Description
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Checking the postural instabilility of patients
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Timepoint
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The beginning of the study (before starting rTMS), the end of receiving rTMS, four months later
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Method of measurement
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Kinematic analysis of scoring movement based on the results of forces and energy
2
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Description
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Checking the speech and swalling of patients
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Timepoint
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The beginning of the study (before starting rTMS), the end of receiving rTMS, four months later
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Method of measurement
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Wanberg's auditory-perceptual assessment index and the Northwestern swallowing disorder test
Secondary outcomes
1
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Description
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کیفیت زندگی بیماران
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Timepoint
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The beginning of the study and the end of the study
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Method of measurement
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PDQL questionnaire
Intervention groups
1
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Description
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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
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Category
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Rehabilitation
2
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All the potential data of movement score and questionnaires and speech and swallowing scores of patients can be shared after making them non-identifiable
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When the data will become available and for how long
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Access starts 6 months to a year after publication
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To whom data/document is available
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only available for people working in academic institutions
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Under which criteria data/document could be used
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It is possible to use the documents of this research only by mentioning the names of its researchers in articles and academic researches.
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From where data/document is obtainable
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from responsible author: Mina Farah Nejad
Email: m.farahnezhad@yahoo.com and farahnezhadm991@mums.ac.ir
Phone number: 00989127635742
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What processes are involved for a request to access data/document
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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
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Comments
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