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Comparison of the effectiveness of transcranial electrical stimulation of the cerebellum, parietal, anterior cingulate and primary motor cortex on adaptation to postural perturbations in healthy adults: Linear and nonlinear approaches

Protocol summary

Study aim
Comparison of the effectiveness of transcranial electrical stimulation of the cerebellum, parietal, anterior cingulate and primary motor cortex on adaptation to postural perturbations in healthy adults: Linear and nonlinear approaches
Design
A randomized, double-blinded, sham-controlled clinical trial with a parallel group design of 75 participants. For randomization, the "randomization.com" website algorithm will be used.
Settings and conduct
The study will be conducted in the rehabilitation school of TUMS. The participants will randomly be distributed to any of the intervention or control groups. After getting baseline information on the central pressure with a force plate, the participant will receive the transcranial direct current stimulation. After that, the measurer who is blind to the participant group will measure their response to perturbation (Achill vibration) with a force plate.
Participants/Inclusion and exclusion criteria
Not having a history of epilepsy Not having pacemaker Not having skin infection Not having metal or implant in head Not having sensory disorder Not having wound or scratch on the scalp Not having cognitive disorder (Mini-Mental State Exam (MMSE) score more than or equal to 24) Not having any history of severe neurologic or musculoskeletal disorders based on the participant's claim Age: 18-40 Healthy people
Intervention groups
Intervention groups of this study will receive high-definition transcranial direct current stimulation over the cerebellum, primary motor cortex, posterior parietal cortex, and anterior cingulate cortex. The sham control group will receive the stimulation in a randomly selected montage.
Main outcome variables
The standard deviation of the displacement, the amplitude of displacement, the length of displacement, the Lyapunov exponent, the approximate entropy, and the correlation dimension of the center of pressure.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220819055745N1
Registration date: 2022-11-15, 1401/08/24
Registration timing: prospective

Last update: 2022-11-15, 1401/08/24
Update count: 0
Registration date
2022-11-15, 1401/08/24
Registrant information
Name
Nastaran bahadorani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 5185
Email address
nbahadorani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of transcranial electrical stimulation of the cerebellum, parietal, anterior cingulate and primary motor cortex on adaptation to postural perturbations in healthy adults: Linear and nonlinear approaches
Public title
Effect of transcranial direct current stimulation of different brain areas on postural adaptation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy people Age 18-40 No history of sever neurologic or musculoskeletal disorders based on the participant's clam Not having cognitive disorder (Mini-Mental State Exam (MMSE) ≥24) No wound or scratch on the scalp No sensory disorder No metal or implant in head No skin infection No pacemaker No history of epilepsy
Exclusion criteria:
Taking any medication that influence balance, neural system or brain. Heavy bodily exertion before experiment Not willing to continue the study
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted Block Randomization method from the website randomization.com will be used for allocating participants to different groups. The size of each block will be 10. A secretary will announce the participant group via a sealed envelope for allocation concealment.
Blinding (investigator's opinion)
Double blinded
Blinding description
To blind participants, there will be a sham control group. To blind the assessor, the therapist that will set the device for stimulation will be different from the therapist who will assess and collect data.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research ethics committees of school of nursing and midwifery and rehabilitation of Tehran universit
Street address
Tehran university of medical science school of rehabilitation, Enghelab street
City
Tehran
Province
Tehran
Postal code
6511111489
Approval date
2022-08-17, 1401/05/26
Ethics committee reference number
IR.TUMS.FNM.REC.1401.066

Health conditions studied

1

Description of health condition studied
Postural adaptation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Standard Deviation of Center of Pressure Displacement: This parameter comes from the second root of the sum of the square of the distance of each center of pressure from the average center of pressure divided by the number of the center of pressure in the anterior-posterior and lateral axis. The scale is in millimeter.
Timepoint
Before and after the intervention
Method of measurement
Force Plate

2

Description
Range of Center of Pressure Displacement: The difference between the maximum and minimum center of pressure displacement in the anterior-posterior and lateral axis. The scale is in millimeters.
Timepoint
Before and after the intervention
Method of measurement
Force Plate

3

Description
Path Length of Center of Pressure Displacement: This parameter comes from the summation of the distance of every center of pressure point from the consecutive point in the anterior-posterior and lateral axis. The scale is in millimeters.
Timepoint
Before and after the intervention
Method of measurement
Force Plate

4

Description
Lyapunov Exponent: Lyapunov Exponent is used to define the system chaos. When consecutive points diverge (divergence) the system will become chaotic, which can be quantified by Lyapunov Exponent.
Timepoint
Before and after the intervention
Method of measurement
To calculate, the Rosenstein algorithm will be used in Chaos Data Analyzer Software.

5

Description
Approximate Entropy: Approximate Entropy is a scale for showing the complexity, regularity, and predictability of the center of pressure time series. In another word, Entropy gives a probability of the existence of a repeatable pattern with the length of m, the similarity of r, and delay of T.
Timepoint
Before and after the intervention
Method of measurement
To calculate, the Pincus algorithm will be used in Matlab Software.

6

Description
Correlation Dimension: Correlation Dimension is a scale that shows degrees of freedom or the dimensions of the time series of the center of pressure.
Timepoint
Before and after the intervention
Method of measurement
To calculate, the Grassberger and Procaccia algorithm will be used in Chaos Data Analyzer Software.

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: This group will receive Transcranial Direct Current Stimulation on posterior parietal cortex by Star Stim device. The amplitude will be 1 milliampere and the duration of stimulation will be 20 minutes.
Category
Rehabilitation

2

Description
Second intervention group: This group will receive Transcranial Direct Current Stimulation on cerebellum by Star Stim device. The amplitude will be 1 milliampere and the duration of stimulation will be 20 minutes.
Category
Rehabilitation

3

Description
Third intervention group: This group will receive Transcranial Direct Current Stimulation on primary motor cortex by Star Stim device. The amplitude will be 1 milliampere and the duration of stimulation will be 20 minutes.
Category
Rehabilitation

4

Description
Forth intervention group: This group will receive Transcranial Direct Current Stimulation on anterior cingulate cortex by Star Stim device. The amplitude will be 1 milliampere and the duration of stimulation will be 20 minutes.
Category
Rehabilitation

5

Description
Sham control group: Second intervention group: This group will receive Transcranial Direct Current Stimulation on any random cite from the intervention groups by Star Stim device. The amplitude will be 1 milliampere and will stop after ramp-up. The ramp-up time is 10 seconds.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran university of medical science rehabilitation school
Full name of responsible person
Nastaran Bahadorani
Street address
Tehran university of medical science school of rehabilitation, Enghelab street
City
Tehran
Province
Tehran
Postal code
6511111489
Phone
+98 910 069 9412
Email
b.nastaran91@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotohi
Street address
6th floor of Research and Technology Vice-Chancellor, Central Organization of the University, Quds St.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Nastaran Bahadorani
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Tehran university of medical science school of rehabilitation, Enghelab street
City
Tehran
Province
Tehran
Postal code
6511111489
Phone
+98 21 6694 5185
Fax
Email
nbahadorani@razi.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Roya Khanmohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tehran university of medical science school of rehabilitation, Enghelab street
City
Tehran
Province
Tehran
Postal code
6511111489
Phone
+98 21 7753 3939
Fax
Email
rkhanmohammadi@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nastaran Bahadorani
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Tehran university of medical science school of rehabilitation, Enghelab street
City
Tehran
Province
Tehran
Postal code
6511111489
Phone
+98 21 6694 5185
Fax
Email
nbahadorani@razi.tums.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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