Protocol summary

Study aim
The comparative effects of transcranial magnetic stimulation (TMS) over motor cortex and cerebellum on the motor learning in the elderly adults
Design
Clinical trial with parallel control group, double blind, randomized, single center trial, Sample size 75 people.
Settings and conduct
Neuromuscular Rehabilitation Research Center Semnan University of Medical Sciences. participants perform the serial task in the shortest possible time with their dominant right hand. People are not given prior information about the order of doing the task. Then, according to the treatment protocol, they are subjected to magnetic stimulation on the motor cortex area and cerebellum.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Elderly people (60-75 years old); The dominant hand of people should be the right hand. Exclusion Criteria: History of neurological diseases such as Parkinson's, Alzheimer's, schizophrenia; Any symptoms of forgetfulness and depression; Having vision, hearing and dizziness disorders; Having symptoms of radiculopathy, carpal tunnel syndrome in the right hand; History of psychological diseases.
Intervention groups
In three group, participants perform the serial task in the shortest possible time with their dominant right hand. People are not given prior information about the order of doing the task. Intervention group 1: Each of the participants after completing the serial task, according to the treatment protocol, they are subjected to magnetic stimulation on the motor cortex area. Intervention group 2: Each of the participants after completing the serial task, according to the treatment protocol, they are subjected to magnetic stimulation on the cerebellum area. Control group: Only for comparison with intervention group, no treatment is performed.
Main outcome variables
Movement learning, Number of errors.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151228025732N73
Registration date: 2022-10-10, 1401/07/18
Registration timing: prospective

Last update: 2022-10-10, 1401/07/18
Update count: 0
Registration date
2022-10-10, 1401/07/18
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
2022-10-12, 1401/07/20
Expected recruitment end date
2023-03-11, 1401/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative effects of transcranial magnetic stimulation (TMS) over motor cortex and cerebellum on the motor learning in the elderly adults
Public title
The comparative effects of transcranial magnetic stimulation (TMS) over motor cortex and cerebellum on the motor learning in the elderly adults
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly people (60-75 years old) The dominant hand of people should be the right hand
Exclusion criteria:
History of neurological diseases such as Parkinson's, Alzheimer's, schizophrenia Any symptoms of forgetfulness and depression Having vision, hearing and dizziness disorders Having symptoms of radiculopathy, carpal tunnel syndrome in the right hand History of psychological diseases
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
We will construct 6 blocks in AABB, BBAA, ABAB, BABA, ABBA, and BAAB using four blocks. We will assign 1 to 6 for each block. Then, using the random number table, based on the sample size, 19 units of 4 blocks will be selected so that we consider having 25 people in the group (A), 25 people in the group (B) and 25 people in the group (C). Therefore, we will do block randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Researcher who complete questionnaire and analyzer and participant will be blind (double blind). Outcome assessor and analyzer and participants will not be aware from grouping.The person evaluating the outcome will be unaware of the grouping. Definition of groups A, B and C will be available to analyzer and outcome assessor.
Placebo
Not used
Assignment
Parallel
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
2022-08-29, 1401/06/07
Ethics committee reference number
IR.SEMUMS.REC.1401.137

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
Movement learning
Timepoint
Immediately and 72 hours after the intervention
Method of measurement
The Color Matching Test (CMT) software will record and measure the time of the homework.

2

Description
Number of errors
Timepoint
Immediately and 48 hours after the intervention
Method of measurement
The Color Matching Test (CMT) software will record and measure the time of the homework.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: In this group, participants perform the serial task in the shortest possible time with their dominant right hand. People are not given prior information about the order of doing the task. Then, according to the treatment protocol, they are subjected to magnetic stimulation on the motor cortex area.
Category
Treatment - Other

2

Description
Intervention group 2: In this group, participants perform the serial task in the shortest possible time with their dominant right hand. People are not given prior information about the order of doing the task. Then, according to the treatment protocol, they are subjected to magnetic stimulation on the cerebellum area.
Category
Treatment - Other

3

Description
Control group: Only for comparison with intervention group, no treatment is performed.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Fatemeh Ehsani
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
Fatemeh Ehsani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
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
Fatemeh Ehsani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
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
Fatemeh Ehsani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
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
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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