Comparison of the effectiveness of transcranial electrical stimulation of the prefrontal, primary motor cortex and cerebellum on the dual-task cost of parameters of gait in older adults
Comparison of the effectiveness of transcranial electrical stimulation of the prefrontal, primary motor cortex and cerebellum on the dual-task cost of parameters of gait in older adults
Design
Randomized, single-blind clinical trial on 19 subjects
Settings and conduct
People are invited to study through invitations posted in physiotherapy clinics, clinics, hospitals, nursing centers, as well as invitations published in cyberspace.
The samples will be selected as simple non-probability sampling, voluntary and based on entry and exit criteria.
Volunteers receive three real stimulations and one sham stimulation in four sessions with an interval of one week in the laboratory of Tehran University of Medical Sciences. Before and after the application of transcranial electric current, the evaluation parameters are recorded in single task and double task mode.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Healthy older adults
Exclusion criteria : Older adults with orthopedic and neurologic problems
Intervention groups
The first intervention group: transcranial electrical stimulation of the prefrontal region
The second intervention group: transcranial electrical stimulation of the primary motor cortex area
The third intervention group: transcranial electrical stimulation of the cerebellum
The fourth intervention group: Unreal transcranial electrical stimulation
Main outcome variables
-Dual-Task Cost of step time
-Dual-Task Cost of step time variability
-Dual-Task Cost of step length
-Dual-Task Cost of step length variability
-Dual-Task Cost of gait velocity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220718055490N1
Registration date:2022-10-01, 1401/07/09
Registration timing:registered_while_recruiting
Last update:2022-10-01, 1401/07/09
Update count:0
Registration date
2022-10-01, 1401/07/09
Registrant information
Name
vahid Rafiee Manesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3375 9083
Email address
vahidrafieemanesh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2023-01-20, 1401/10/30
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 prefrontal, primary motor cortex and cerebellum on the dual-task cost of parameters of gait in older adults
Public title
Comparison of the effectiveness of transcranial electrical stimulation on the dual-task cost of parameters of gait in older adults
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 65
Berg Balance Scale (BBS) >40
Mini-Mental State Exam (MMSE) ≥24
Hospital Anxiety and Depression Scale (HADS- Depression subscale) ≤7
Ability of reading and writing
ability of walking without aids in 10 meters
No history of CNS and PNS problems
No history of orthopedic problem in recent 6 months
No history of falling in recent 6 months
No scalp scratch
No sensory impairment
no history of epilepsy
no metal implant in cranium
No skin infection
No pacemaker or electronic implants
Exclusion criteria:
Use narcotics or pain killers 24 hours before
Severe activity 24 hours before
Unusual physical or mental exhaustion
Unwilling to do or continue
Age
From 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Based on the three locations of real stimulation and one sham stimulation that is planned in this study, we assign one of the letters of the alphabet (A, B, C, D) to each stimulation, and people are randomly assigned in 4 sequences (BDC, BCAD , CDBA and DACB) are divided according to the brain stimulation area and it is determined what type of stimulation should be done in each session. Before the start of the first session, a sealed and numbered envelope is used in which the type of stimulation sequence is placed. It is provided by the secretary to the participants. As a result, the participants are blinded to the type of stimulation that is applied. However, according to the study design and the type of stimulation that is applied by the therapist, it is not possible for the therapists and the evaluator to be blind.
Placebo
Used
Assignment
Parallel
Other design features
All people participating in the study will receive three types of real stimulation and one non-real stimulation alternately with different sequences, and the aim is to compare the interventions.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
2th Floor,No. 31,mohammadi St, Ghayoori St ,Ray, Tehran
City
Tehran
Province
Tehran
Postal code
1857814959
Approval date
2022-08-07, 1401/05/16
Ethics committee reference number
IR.TUMS.FNM.REC.1400.193
Health conditions studied
1
Description of health condition studied
Dual task cost in older adults
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Dual task cost
Timepoint
Assessment of Dual task cost before and after TDCS in every session
Method of measurement
Inertial sensor
Secondary outcomes
1
Description
Assessment of balance and fall risk
Timepoint
After completing the study
Method of measurement
Berg Balance Scale Questionnaire
Intervention groups
1
Description
The first intervention group: a session of transcranial electrical stimulation of the prefrontal area using the Star stim device manufactured by the company (Starstim, Neuroelectrics, Barcelona, Spain) with an intensity of 2 mA and for 20 minutes.
Category
Rehabilitation
2
Description
205 / 5,000Translation resultsThe second intervention group: a session of transcranial electrical stimulation of the primary motor cortex using the Star stim device manufactured by the company (Starstim, Neuroelectrics, Barcelona, Spain) with an intensity of 2 mA and for 20 minutes.
Category
Rehabilitation
3
Description
The third intervention group: a session of transcranial electrical stimulation of the cerebellum using the Star stim device manufactured by the company (Starstim, Neuroelectrics, Barcelona, Spain) with an intensity of 2 mA and for 20 minutes.
Category
Rehabilitation
4
Description
Control group: a non-real transcranial electrical stimulation session in one of the prefrontal areas, primary motor cortex or cerebellum using the Star stim device manufactured by the company (Starstim, Neuroelectrics, Barcelona, Spain) with an intensity of 2 mA and for 20 minutes