Cognitive SymptomNCT04873804
The Effect of Transcranial Direct Stimulation on Cognitive Functions of Healthy Adults
A study testing Transcranial Direct Current Stimulation in people with Cognitive Symptom and Healthy, run by Medipol University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Symptom, Healthy
- What is being tested?
- Transcranial Direct Current Stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 10 Oct 2019to 10 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- being 18-30 years old
Who cannot join
- alcohol and substance addiction
- previous mental illness
- having mental and cognitive problems
- a history of head trauma
- having cardiovascular disease.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Damla Ören
Istanbul, 34000
Medipol Mega Hospital
Istanbul, 34000
About this study
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
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.
- Conditions
- Cognitive Symptom, Healthy
- Being tested
- Transcranial Direct Current Stimulation
- Keywords
- tDCS, Dorsolateral Prefrontal Cortex, Posterior Parietal Cortex, Cognitive Function
- Medical subject headings
- Neurobehavioral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| LEFT DLPFC | Active comparator | The anode electrode of tDCS was applied to the left DLPFC and the cathode electrode was connected to the contralateral shoulder. Receives: Other: Transcranial Direct Current Stimulation |
| RİGHT PPC | Active comparator | The anode electrode of tDCS was applied to the right PPC and the cathode electrode was connected to the contralateral shoulder. Receives: Other: Transcranial Direct Current Stimulation |
| Sham | Sham comparator | Placebo was applied by placing the electrodes in the right PPC and left DLPFC without applying current. Receives: Other: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychiatric Test Battery
It is a test battery for getting detailed information about general cognitive status.
Measured: 3 weeks
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
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start10 Oct 2019
- Primary completion10 May 2020
- Study completion10 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive SymptomStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Ören, Medipol University
- Investigators
- Miray Budak, PhD, Principal investigator, Medipol UniversityLutfu Hanoglu, PhD, Study chair, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873804
- Sponsor's protocol ID
- tDCS on DLPFC and PPC
- Status last verified
- May 2021
- First submitted
- 14 Apr 2021
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04873804
- Acronym / sponsor ID
- tDCS on DLPFC and PPC
- Conditions
- Cognitive Symptom, Healthy
- Keywords
- tDCS, Dorsolateral Prefrontal Cortex, Posterior Parietal Cortex, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 10 May 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LEFT DLPFC | Active comparator | Other: Transcranial Direct Current StimulationThe anode electrode of tDCS was applied to the left DLPFC and the cathode electrode was connected to the contralateral shoulder. |
| RİGHT PPC | Active comparator | Other: Transcranial Direct Current StimulationThe anode electrode of tDCS was applied to the right PPC and the cathode electrode was connected to the contralateral shoulder. |
| Sham | Sham comparator | Other: Transcranial Direct Current StimulationPlacebo was applied by placing the electrodes in the right PPC and left DLPFC without applying current. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- being 18-30 years old
Key exclusion criteria (5 listed)
- alcohol and substance addiction
- previous mental illness
- having mental and cognitive problems
- a history of head trauma
- having cardiovascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current StimulationThe 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. | Other | LEFT DLPFC, RİGHT PPC, Sham |
Primary outcome
Neuropsychiatric Test Battery
Time frame: 3 weeks
It is a test battery for getting detailed information about general cognitive status.
Beck Depression Scale
Time frame: 3 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miray Budak, PhD principal investigator
Medipol University
Lutfu Hanoglu, PhD study chair
Medipol University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation in people with Cognitive Symptom and Healthy, run by Medipol University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychiatric Test Battery (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.