Investigating the effects of repetitive Transcranial Magnetic Stimulation (rTMS) on Stuttering Severity in Adults Who Stutter
Design
Clinical trial, non-randomized, single center, no blinding, sample size 4 people.
Settings and conduct
Neuromuscular Rehabilitation Research Center Semnan University of Medical Sciences.
Magnetic brain stimulation, using a non-invasive transcranial magnetic stimulation device with a frequency of 1 Hz for 20 minutes (1200 pulses) with an intensity of 90% of the motor threshold and during 10 treatment sessions will be used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People with developmental stuttering based on the results of the SSI-4 test; People over 18 years old; Only Persian speaking; No neurological problems; Do not have accompanying psychiatric disorders such as autism; Not receiving any treatment for stuttering in the last 3 months.
Exclusion Criteria: Suffering from any type of disease that prevents cooperation in the continuation of the intervention.
Intervention groups
Intervention group: 4 people over 18 years of age according to the therapeutic protocol of magnetic brain stimulation, using a non-invasive transcranial magnetic stimulation device with a frequency of 1 Hz for 20 minutes (1200 pulses) with an intensity of 90% of the motor threshold and during 10 treatment sessions will be used. (Mag Survey 100HZ MSV-100 device model)
Main outcome variables
Stuttering severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N80
Registration date:2023-12-31, 1402/10/10
Registration timing:prospective
Last update:2023-12-31, 1402/10/10
Update count:0
Registration date
2023-12-31, 1402/10/10
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-10, 1402/10/20
Expected recruitment end date
2024-05-09, 1403/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of repetitive Transcranial Magnetic Stimulation (rTMS) on Stuttering Severity in Adults Who Stutter
Public title
Investigating the effects of repetitive Transcranial Magnetic Stimulation (rTMS) on Stuttering Severity in Adults Who Stutter
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
People with developmental stuttering based on the results of the SSI-4 test.
People over 18 years old
Only Persian speaking.
No neurological problems
Do not have accompanying psychiatric disorders such as autism.
Not receiving any treatment for stuttering in the last 3 months
Exclusion criteria:
Suffering from any type of disease that prevents cooperation in the continuation of the intervention.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
4
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2023-10-02, 1402/07/10
Ethics committee reference number
IR.SEMUMS.REC.1402.146
Health conditions studied
1
Description of health condition studied
Movement disorder
ICD-10 code
F82
ICD-10 code description
Specific developmental disorder of motor function
Primary outcomes
1
Description
Stuttering severity
Timepoint
The beginning and end of each session will be done.
Intervention group: 4 people over 18 years of age according to the therapeutic protocol of magnetic brain stimulation, using a non-invasive transcranial magnetic stimulation device with a frequency of 1 Hz for 20 minutes (1200 pulses) with an intensity of 90% of the motor threshold and during 10 treatment sessions will be used. (Mag Survey 100HZ MSV-100 device model)
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Seyed Abolfazl Tohidast
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
are20935@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mirmohammadkhani
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
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
Seyed Abolfazl Tohidast
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
are20935@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Seyed Abolfazl Tohidast
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
are20935@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Seyed Abolfazl Tohidast
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
are20935@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