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The effect of the supplementary motor area (SMA) transcranial photobiomodulation on charachteristics of motor performance during sequential finger tapping task: a randomized controlled trial

Protocol summary

Study aim
Determine the effect of the supplementary motor area (SMA) transcranial photobiomodulation (tPBM) on charachteristics of motor performance during sequential finger tapping task
Design
A controlled, parallel-group, single-blind, randomized clinical trial using a simple randomization method on 36 participants.
Settings and conduct
All project participants will be studied in the rehabilitation clinic and the brain and cognition laboratory of Tabriz University of Medical Sciences under treatment with the desired tools. Study subjects will be randomly assigned to two groups: 1. Intervention with tPBM and 2. Sham group. In order to apply tPBM intervention, a transcranial optical modulation cap will be used.This study will be done in a blind way, in which the participants will not know about the intervention and in which of the groups.
Participants/Inclusion and exclusion criteria
Students of rehabilitation faculty of Tabriz University of Medical Sciences with an average age of 18-30 years
Intervention groups
The light will be emitted by a near-infrared wave projector, with a specific wavelength of 850 nm, continuously, with a power of 2400 mW/cm and an energy density of 24 J/cm. The desired wavelength is irradiated on the complementary movement area for 10 minutes. This area is the area that is involved in activities related to motor performance. The intervention using cranial light therapy will be done on only half of the participants, while the other half of the participants, the placebo group, will receive the intervention in the form of a sham. The intervention is similar to the intervention group (10 minutes), but in total, radiation will only be applied for 5 seconds per minute.
Main outcome variables
The order and accuracy of the sequence of tapping , reaction time, time interval between finger taps, round trip time as indicators of motor performance.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230207057347N1
Registration date: 2023-12-23, 1402/10/02
Registration timing: retrospective

Last update: 2023-12-23, 1402/10/02
Update count: 0
Registration date
2023-12-23, 1402/10/02
Registrant information
Name
Zahra Heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3378 2419
Email address
z.heidari_72@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-01, 1402/03/11
Expected recruitment end date
2023-08-02, 1402/05/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the supplementary motor area (SMA) transcranial photobiomodulation on charachteristics of motor performance during sequential finger tapping task: a randomized controlled trial
Public title
The effect of transcranial photobiomodulation on motor performance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Right-handed people Age range from 18 to 30 years
Exclusion criteria:
Uncorrected eye diseases Neurological or orthopedic disorder of the upper limb (trigger finger, CTS,...) sleep disorder pregnancy History of seizures Having a profession or repetitive manual activities (such as being a pianist or a typist) Taking drugs or special drugs affecting the nervous system History of neuro-psychological diseases
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
We have two envelopes, one with men and the other with women. Inside each of them are 18 small envelopes, which are randomly written on each of them. As soon as each person enters, he chooses an envelope related to a man or a woman, and I take a number of small envelopes to determine the person's placement in the sham or intervention group, the participant does not know his group.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be done in a blind way. The envelope related to the placement of the person in the sham or intervention group will be opened by the researcher and the participant will not know about his group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committe of Tabriz university of Medical sciences
Street address
29 Bahman avenue, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Approval date
2023-04-17, 1402/01/28
Ethics committee reference number
IR.TBZMED.REC.1402.085

Health conditions studied

1

Description of health condition studied
Mental fatigue
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Sequential finger tapping motor performance
Timepoint
Before mental fatigue, after mental fatigue, after transcranial photobiomodulation
Method of measurement
Sequential finger tapping motor task

Secondary outcomes

1

Description
Attentional performance
Timepoint
Before mental fatigue, after mental fatigue, after transcranial photobiomodulation
Method of measurement
Go/No go cognitive test

Intervention groups

1

Description
Intervention group: For this group, transcranial optical adjustment will be performed in one session. The light will be emitted through a near-infrared light cap with a wavelength of 850 nm, with a power of 400 mW and an energy density of 24 J/cm. The source of light production in this projector is light diodes. The desired wavelength, for 10 minutes, is radiated on the motion complementary area on the point with coordinates 3 cm further and 2 cm to the right and left of the central zero point. This area is the area that is involved in activities related to motor function. Electrodes are placed on a pre-set optical cap that is adjusted according to the 20-10 system electrode placement in EEG.
Category
Rehabilitation

2

Description
Control group: The other half of the participants, i.e. the sham group, are exposed to radiation in a false way, in such a way that the radiation is only applied to the target area for 5 seconds per minute.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Rehabilitation Sciences
Full name of responsible person
Maryam Moghadam salimi
Street address
29 Bahman Ave, Tabriz University of medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3325 1499
Email
moghadamm@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Heidari
Street address
29 Bahman Ave, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3346 0704
Email
Z.heidari_72@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Maryam Moghadam salimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
29 Bahman Ave, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3325 1499
Fax
Email
moghadamm@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Maryam Moghadam Salimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
29 Bahman Ave, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3325 1499
Fax
Email
moghadamm@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Maryam Moghadam Salimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
29 Bahman Ave,Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3325 1499
Fax
Email
moghadamm@tbzmed.ac.ir

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
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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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