The Effect of Transcranial Direct Stimulation on Cognitive Functions of Healthy Adults
Primary Purpose
Cognitive Symptom, Healthy
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sponsored by
About this trial
This is an interventional diagnostic trial for Cognitive Symptom focused on measuring tDCS, Dorsolateral Prefrontal Cortex, Posterior Parietal Cortex, Cognitive Function
Eligibility Criteria
Inclusion Criteria:
- being 18-30 years old
Exclusion Criteria:
- alcohol and substance addiction
- previous mental illness
- having mental and cognitive problems
- a history of head trauma
- having cardiovascular disease.
Sites / Locations
- Damla Ören
- Medipol Mega Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Sham Comparator
Arm Label
LEFT DLPFC
RİGHT PPC
Sham
Arm Description
The anode electrode of tDCS was applied to the left DLPFC and the cathode electrode was connected to the contralateral shoulder.
The anode electrode of tDCS was applied to the right PPC and the cathode electrode was connected to the contralateral shoulder.
Placebo was applied by placing the electrodes in the right PPC and left DLPFC without applying current.
Outcomes
Primary Outcome Measures
Neuropsychiatric Test Battery
It is a test battery for getting detailed information about general cognitive status.
Beck Depression Scale
It measures the symptoms seen in depression such as emotional, cognitive and motivational. It includes 21 items determine a behavioral feature related to depression. Items are numbered from 0 to 3. The goal is to objectively break down the degree of symptoms.
The total score of all answers is calculated as follows:
0 to 9 points: Minimally depressive symptoms 10 to 16 points: Mild depressive symptoms Between 17 and 29 points: Moderate depressive symptoms Between 30 and 63 points: Severe depressive symptoms
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04873804
Brief Title
The Effect of Transcranial Direct Stimulation on Cognitive Functions of Healthy Adults
Official Title
The Effect Of Transcranial Direct Stimulation Applied To The Dorsolateral Prefrontal Cortex And Posterior Parietal Cortex İn Cognitive Function, Mood And Proprioception İn Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
May 10, 2020 (Actual)
Study Completion Date
June 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background: Transcranial direct current stimulation(tDCS) has been used to improve cognitive functions in healthy young adults.
Purpose: To investigate the effect of TDCS application on different cortex regions on cognitive function.
Methods: Sixty individuals aged 18-30 were included in the study. The participants were randomly divided into the left dorsolateral prefrontal cortex (Left DLPFC Group)(n=20), the right posterior parietal cortex (Right PPC Group)(n=20), and the sham group (Sham Group)(n=20). tDCS was applied for 20 minutes on weekdays for 2 weeks. The participants were evaluated in terms of cognitive functions with Neuropsychometric Test Battery before and after treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Symptom, Healthy
Keywords
tDCS, Dorsolateral Prefrontal Cortex, Posterior Parietal Cortex, Cognitive Function
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LEFT DLPFC
Arm Type
Active Comparator
Arm Description
The anode electrode of tDCS was applied to the left DLPFC and the cathode electrode was connected to the contralateral shoulder.
Arm Title
RİGHT PPC
Arm Type
Active Comparator
Arm Description
The anode electrode of tDCS was applied to the right PPC and the cathode electrode was connected to the contralateral shoulder.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Placebo was applied by placing the electrodes in the right PPC and left DLPFC without applying current.
Intervention Type
Other
Intervention Name(s)
Transcranial Direct Current Stimulation
Intervention Description
The intervention protocols were applied using tDCS (Teknofil TESsaNova). All individuals received 2 mA of anodal tDCS for 2 weeks on weekdays. All applications were done in the form of 20-minute sessions.
Primary Outcome Measure Information:
Title
Neuropsychiatric Test Battery
Description
It is a test battery for getting detailed information about general cognitive status.
Time Frame
3 weeks
Title
Beck Depression Scale
Description
It measures the symptoms seen in depression such as emotional, cognitive and motivational. It includes 21 items determine a behavioral feature related to depression. Items are numbered from 0 to 3. The goal is to objectively break down the degree of symptoms.
The total score of all answers is calculated as follows:
0 to 9 points: Minimally depressive symptoms 10 to 16 points: Mild depressive symptoms Between 17 and 29 points: Moderate depressive symptoms Between 30 and 63 points: Severe depressive symptoms
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
being 18-30 years old
Exclusion Criteria:
alcohol and substance addiction
previous mental illness
having mental and cognitive problems
a history of head trauma
having cardiovascular disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miray Budak, PhD
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lutfu Hanoglu, PhD
Organizational Affiliation
Medipol University
Official's Role
Study Chair
Facility Information:
Facility Name
Damla Ören
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey
Facility Name
Medipol Mega Hospital
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
The Effect of Transcranial Direct Stimulation on Cognitive Functions of Healthy Adults
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