Determine the effect of transcranial direct current stimulation on motor learning of serial reaction time task in in high and low activity elderly
Design
This study is a randomized clinical trial with single blind, sham-controlled. All participants are divided to High Activity and Low Activity groups according to their physical activity level. Participants in each of these group are randomly divided to stimulation on primary motor cortex group and sham stimulation group to create four groups.
Settings and conduct
Research population: All elderly living in the elderly homes of Qom.
Reaction time and number of error are recorded before the intervention (day 1), immediately after the intervention (day 5), 1 and 10 days after the completion of the intervention.
Participants/Inclusion and exclusion criteria
Healthy and right handed elderly that do not have disability in the upper extremity and memory problems.
Intervention groups
Participants practice 8 blocks of serial reaction time task during 5 consecutive days. Transcranial direct current stimulation is applied during the whole course of the motor training. Stimulation is applied on mentioned areas with 1mA current, 0.16 mA/cm2 current density for 20 minutes during 5 consecutive days. In sham stimulation, same current is applied only for the first 30 s and in the remained time, the current is turned off without the awareness of person.
Main outcome variables
Reaction time؛ Number of errors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200809048346N1
Registration date:2020-11-07, 1399/08/17
Registration timing:prospective
Last update:2020-11-07, 1399/08/17
Update count:0
Registration date
2020-11-07, 1399/08/17
Registrant information
Name
Razieh Abedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3294 1553
Email address
raziehabedi28@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of transcranial direct current stimulation of primary motor cortex in improving motor learning in high and low activity elderly.
Public title
The effect of transcranial direct current stimulation on motor learning in elderly.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy elderly
Right-handed
Exclusion criteria:
History of neurological diseases
Visual or auditory conditions
Serious memory deficits
Musculoskeletal disorders especially in the upper extremity
Age
From 65 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a sample of 60 people, 30 cards for each intervention group were considered and placed inside a sealed envelope that is non-transparent to draw then each patient takes one of the cards randomly and their group is identified and the generated sequence is recorded.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are unaware of the allocation of study groups. In sham stimulation, there is a gradual increase in current for only 30 seconds at the beginning of the stimulation, and the rest of the time, the current is interrupted, so that similar to the real stimulation, the person feels initial burning and itching and the person will not notice the lack of flow throughout the stimulation session.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
No. 32, Alley. 92, Kashani Ave., Qom City
City
Qom
Province
Ghoum
Postal code
3718759573
Approval date
2020-06-28, 1399/04/08
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.268
Health conditions studied
1
Description of health condition studied
Motor learning
ICD-10 code
Z50
ICD-10 code description
Care involving use of rehabilitation procedures
Primary outcomes
1
Description
Reaction time
Timepoint
Before and after intervention, 1 and 10 days after intervention
Method of measurement
In millisecond and using Superlab5 software
Secondary outcomes
1
Description
Number of errors in each block
Timepoint
Before and after intervention, 1 and 10 days after intervention
Method of measurement
Based on the number and using Superlab5 software
Intervention groups
1
Description
Intervention group: Transcranial direct current stimulation of primary motor cortex, 1 milliampere current intensity, 0.16 milliampere/square centimeter current density, 20 minutes time of stimulation, Five consecutive days.
Category
Rehabilitation
2
Description
Control group: Transcranial direct current stimulation, Sham stimulation, 1 milliampere current intensity only for the first 30 s, Turned off current for remained 20 minutes time of stimulation, Five consecutive days.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Fayyaz Bakhsh Nursing and Rehabilitation Center
Full name of responsible person
Razieh Abedi
Street address
Shahid Fayyaz Bakhsh Nursing and Rehabilitation Center, Shahid Mahallati Square, Panardeh Khordad Boulevard, Qom City, Iran