Alzheimer DiseaseNCT05919485
The Effects of Specific tDCS on Cognition in MCI
A study testing tDCS in people with Alzheimer Disease and Parkinson Disease, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
INTRODUCTION: Mild cognitive impairment (MCI) is a critical transitional stage in dementia related disorders. Dorsolateral prefrontal cortex (DLPFC), and the lateral parietal (LPC) cortex are subjected to neuropathological changes in MCI. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Alzheimer Disease, Parkinson Disease
- What is being tested?
- tDCS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Providing an informed consent;
- Literate and between 45-80 years of age;
- 60 females and 60 males;
- Diagnosed with PD based on criteria suggested by UK Parkinson's Disease Society, Brain Bank and PD-MCI in accordance with the diagnostic criteria suggestions by Litvan;
- Diagnosed with aMCI based on diagnosis criteria (CDR\>0.5) suggested by Petersen;
- On a stable pharmacological treatment minimum for one month with no washout period.
Who cannot join
- Illiterate or education level less than primary school
- Having an existing and/or prior neurological disease; psychiatric disease or head trauma; and/or irreversible hearing or sight problems or other medical illness (e.g. diabetes mellitus, hypertension);
- Exhibiting signs of dementia for PD group ;
- Having medical issues that prevent undergoing fMRI or for tDCS application.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Alanya Alaaddin Keykubat Üniversitesi
Antalya, Alanya, 33333
Cennet Sena Parlatan, pHD Cand, 05077799164, cennet.parlatan@std.medipol.edu.tr
About this study
Official title: The Effects of Specific Transcranial Direct Current Stimulation tDCS on Cognition in Mild Cognitive Impairment: A Novel Study Protocol
INTRODUCTION:
Mild cognitive impairment (MCI) is a critical transitional stage in dementia related disorders. Dorsolateral prefrontal cortex (DLPFC), and the lateral parietal (LPC) cortex are subjected to neuropathological changes in MCI. Parietal memory network (PMN) integrity alterations and default mode network (DMN) alterations also occur in MCI. Transcranial direct current stimulation (tDCS) is a promising neuroprotective tool that modulates functional connectivity and might be useful to interfere with cognitive decline in relation to amnestic MCI (aMCI) and Parkinson's disease-MCI (PD-MCI) when applied to DLPFC and LPC.
Read more
METHODS:
This is a multicenter, randomized, and controlled study evaluating the effectiveness of anodal tDCS (atDCS ) applied bilaterally to the DLPFC/F3-F4 and LPC/ P3-P4 for 5 sessions with a total of 10 sessions in 14 days. The stimulation will be delivered with a 2 mA current frequency and will last 20 minutes a day for 5 days a week. The study consists of anodal, and sham control groups with a total of 120 participants with DLPFC and LPC anodal groups including 40 participants each and sham including 40 participants which are all between 45-80 years of age.
At baseline and as an outcome measure, neurocognitive evaluation will be conducted using various tests standardized to use in the Turkish population. Functional magnetic resonance (fMRI) will be used to detect possible PMN and DMN alterations and hippocampal connectivity, and electroencephalogram (EEG) will be used to assess possible electrophysiological alterations that may happen as a result of atDCS. Baseline evaluation will be done before atDCS sessions and it will be repeated at the end of 14 days and 90 days.
DISCUSSION:
This study aims to explore the effectiveness of atDCS in PD-MCI, aMCI and to contribute to the literature in the field.
Read the detailed description
Study Design This is a multi-center, randomized, controlled study registered and carried out at Medipol University Hospital and Alaaddin Keykubat University Training and Research Hospital. The objective of the study is to evaluate the effectiveness of atDCS stimulation over DLPFC and LPC on cognitive skills of patients with PD-MCI and aMCI.
The patients will be randomized to 2mA tDCS over DLPFC and over LPC, or Sham control. tDCS stimulation will last for 20 minutes a day for 5 consecutive days, a total of 10 sessions in 14 days. The outcome of the simulations will be evaluated by various neurocognitive tests at the baseline, at the end of 14 days and then, 90 days.
Brain connectivity will be analyzed by resting state-functional magnetic resonance imaging (fMRI) and neuronal activity will be analyzed by electroencephalography (EEG) at the baseline, at the end of 14 days and 90 days..
This study aims to give important translational messages in the field of clinical neuroscience by exploring the pro-cognitive effects of tDCS application including its optimal application methods. In this framework, the restorative benefits of tDCS can be critical to understand the cause-effect relationship between certain neural circuits and behavioral outcomes, which might be important in understanding the pathophysiology of MCI and PD. From another point of view, our findings might be valuable in terms of prolonged life-expectancy and the maintenance of preserved cognitive skills in the elderly.
Although tDCS is still in a premature stage, it has certain advantages in terms of portability, cost-effectiveness and user-friendly application compared to other non- invasive stimulation applications. This study will contribute to the growing literature in terms of its optimal application methods, side-effects and long-term (90 days) neurobehavioral results.
- Conditions
- Alzheimer Disease, Parkinson Disease
- Being tested
- tDCS
- Keywords
- Mild cognitive impairment, Alzheimer's disease, Parkinson's disease, Transcranial direct current stimulation
- Medical subject headings
- Alzheimer Disease, Parkinson Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSProcedure or surgery
0.06mA/cm2 from each electrode with total density of 0.054/cm2 for 20 minutes for 5 days a week, for 10 days and a total of 10 sessions in 14 days.
Brain area; DLPFC / LPC
| Study group | Role | What they receive |
|---|---|---|
| Interventional-DLPFC | Experimental | DLPC/F3-F4 group will consist of 20 PD-MCI patients and 20 aMCI patients; 2mA anodal tDCS over DLPFC The current density will be 0.06mA/cm2 from each electrode with total density of 0.054/cm2 and will be delivered for 20 minutes for the atDCS group for 5 days a week, for 10 days and a total of 10 sessions in 14 days. Receives: Procedure: tDCS |
| Interventional-LPC | Experimental | LPC/P3-P4 group will consist of 20 PD-MCI patients and 20 aMCI patients; 2mA anodal tDCS over LPC The current density will be 0.06mA/cm2 from each electrode with total density of 0.054/cm2 and will be delivered for 20 minutes for the atDCS group for 5 days a week, for 10 days and a total of 10 sessions in 14 days. Receives: Procedure: tDCS |
| Sham | Sham comparator | Sham control group will consist of 40 patients (20 aMCI and 20 PD-MCI patients).
2mA anodal sham tDCS protocol. For the sham protocol, the stimulation will be delivered for one time with a very low current frequency, enough to cause slight tingling, and for 15 seconds long which will also be delivered for 20 minutes, 5 days a week, for 10 days and a total of 10 sessions in 14 days. Receives: Procedure: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological Tests Scores
Moca, AdCom Scores
Measured: Changes Before Treatment and 14 Days&90 Days after treatment
Secondary outcomes (4)
EEG Power Spectrum Analysis
EEG data will be separated into one-second epochs after they are cleared of noise. Power spectrums of these data will be obtained in the delta, theta, alpha, beta and gamma frequency bands. Each epoch will be analyzed by Fast Fourier Transform (FFT, Fast Fourier Transform) with 10% Hanning window, then power spectrum analysis will be performed, giving the frequency values for each electrode by averaging all FFTs. Maximum peaks will be determined in the delta (0.5-3.5 Hz), theta (4-7 Hz), alpha (8-13 Hz), beta (15-28 Hz) and gamma (28-48 Hz) frequency bands. these values will be used in statistical analysis for each person and electrode.
Measured: Changes Before Treatment and 14 Days after treatment
EEG Coherence Analysis
Coherence measurements at delta, theta, alpha, beta and gamma frequencies can be analyzed for either intra-hemispheric electrode connections or inter-hemipheric electrode connections.Coherence values take values between 0-1. Values close to 0 indicate that there is no connection at the determined frequency between the two calculated electrode regions, while values close to 1 indicate a high coupling between the two electrode regions. Coherence values will be calculated with the Brain Vision Analyzer program using the formula below.The data obtained during memory and visualization will be separated into one-second epochs after they are cleared of noise.Power spectrums of these data will be obtained in the delta, theta, alpha, beta and gamma frequency bands. Each epoch will be analyzed by Fast Fourier Transform with 10% Hanning window.Then, these data will be calculated for all possible electrode pairs using the brain vision analysis program with the formula given below.
Measured: Changes Before Treatment and 14 Days after treatment
EEG functional connectivity analysis
eLORETA software will be used for functional connectivity analysis. sLORETA /eLORETA is an online free software developed by Roberto Pascual-Marqui and his team (http://www.uzh.ch/keyinst/loreta.htm). eLORETA is an algorithm developed to solve the inverse problem and it does not contain localization bias even in the presence of noise . In this software, resting state data with eyes closed, separated into 2 second epochs, whose artifacts are cleaned by preprocessing, will be used. The relevant areas to be analyzed in the cortical plane and the relevant frequency band gaps will be determined. The time series containing the eLORETA current source density obtained from these areas will be calculated and a "lagged linear coherence" matrix will be created to be applied in graph theory (Vecchio et al., 2014). "Lagged linear coherence" will give correct physiological connectivity unaffected by volume conduction and low spatial resolution.
Measured: Changes Before Treatment and 14 Days after treatment
Volumetric Magnetic resonance Imaging (MRI) and functional magnetic resonance imaging (rest-fMRI)
The change in central nervous system atrophy and resting state network activity between the groups.
Measured: Changes Before Treatment and 14 Days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start1 Aug 2023
- Primary completion30 Dec 2023
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Alanya Alaaddin Keykubat University
- Responsible party
- Principal investigator, Prof. Lutfu Hanoglu, MD, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919485
- Sponsor's protocol ID
- 2023IMU_ALKU
- Status last verified
- Apr 2025
- First submitted
- 8 Jun 2023
- Last updated
- 2 May 2025
- 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 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Specific Transcranial Direct Current Stimulation tDCS on Cognition in Mild Cognitive Impairment: A Novel Study Protocol
- ClinicalTrials.gov ID
- NCT05919485
- Acronym / sponsor ID
- 2023IMU_ALKU
- Conditions
- Alzheimer Disease, Parkinson Disease
- Keywords
- Mild cognitive impairment, Alzheimer's disease, Parkinson's disease, Transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- Alanya Alaaddin Keykubat University
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 26 Jun 2023 (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.
INTRODUCTION:
Mild cognitive impairment (MCI) is a critical transitional stage in dementia related disorders. Dorsolateral prefrontal cortex (DLPFC), and the lateral parietal (LPC) cortex are subjected to neuropathological changes in MCI. Parietal memory network (PMN) integrity alterations and default mode network (DMN) alterations also occur in MCI. Transcranial direct current stimulation (tDCS) is a promising neuroprotective tool that modulates functional connectivity and might be useful to interfere with cognitive decline in relation to amnestic MCI (aMCI) and Parkinson's disease-MCI (PD-MCI) when applied to DLPFC and LPC.
METHODS:
This is a multicenter, randomized, and controlled study evaluating the effectiveness of anodal tDCS (atDCS ) applied bilaterally to the DLPFC/F3-F4 and LPC/ P3-P4 for 5 sessions with a total of 10 sessions in 14 days. The stimulation will be delivered with a 2 mA current frequency and will last 20 minutes a day for 5 days a week. The study consists of anodal, and sham control groups with a total of 120 participants with DLPFC and LPC anodal groups including 40 participants each and sham including 40 participants which are all between 45-80 years of age.
At baseline and as an outcome measure, neurocognitive evaluation will be conducted using various tests standardized to use in the Turkish population. Functional magnetic resonance (fMRI) will be used to detect possible PMN and DMN alterations and hippocampal connectivity, and electroencephalogram (EEG) will be used to assess possible electrophysiological alterations that may happen as a result of atDCS. Baseline evaluation will be done before atDCS sessions and it will be repeated at the end of 14 days and 90 days.
DISCUSSION:
This study aims to explore the effectiveness of atDCS in PD-MCI, aMCI and to contribute to the literature in the field.
Detailed description
Study Design This is a multi-center, randomized, controlled study registered and carried out at Medipol University Hospital and Alaaddin Keykubat University Training and Research Hospital. The objective of the study is to evaluate the effectiveness of atDCS stimulation over DLPFC and LPC on cognitive skills of patients with PD-MCI and aMCI.
The patients will be randomized to 2mA tDCS over DLPFC and over LPC, or Sham control. tDCS stimulation will last for 20 minutes a day for 5 consecutive days, a total of 10 sessions in 14 days. The outcome of the simulations will be evaluated by various neurocognitive tests at the baseline, at the end of 14 days and then, 90 days.
Brain connectivity will be analyzed by resting state-functional magnetic resonance imaging (fMRI) and neuronal activity will be analyzed by electroencephalography (EEG) at the baseline, at the end of 14 days and 90 days..
This study aims to give important translational messages in the field of clinical neuroscience by exploring the pro-cognitive effects of tDCS application including its optimal application methods. In this framework, the restorative benefits of tDCS can be critical to understand the cause-effect relationship between certain neural circuits and behavioral outcomes, which might be important in understanding the pathophysiology of MCI and PD. From another point of view, our findings might be valuable in terms of prolonged life-expectancy and the maintenance of preserved cognitive skills in the elderly.
Although tDCS is still in a premature stage, it has certain advantages in terms of portability, cost-effectiveness and user-friendly application compared to other non- invasive stimulation applications. This study will contribute to the growing literature in terms of its optimal application methods, side-effects and long-term (90 days) neurobehavioral results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interventional-DLPFC | Experimental | Procedure: tDCSDLPC/F3-F4 group will consist of 20 PD-MCI patients and 20 aMCI patients; 2mA anodal tDCS over DLPFC The current density will be 0.06mA/cm2 from each electrode with total density of 0.054/cm2 and will be delivered for 20 minutes for the atDCS group for 5 days a week, for 10 days and a total of 10 sessions in 14 days. |
| Interventional-LPC | Experimental | Procedure: tDCSLPC/P3-P4 group will consist of 20 PD-MCI patients and 20 aMCI patients; 2mA anodal tDCS over LPC The current density will be 0.06mA/cm2 from each electrode with total density of 0.054/cm2 and will be delivered for 20 minutes for the atDCS group for 5 days a week, for 10 days and a total of 10 sessions in 14 days. |
| Sham | Sham comparator | Procedure: tDCSSham control group will consist of 40 patients (20 aMCI and 20 PD-MCI patients). 2mA anodal sham tDCS protocol. For the sham protocol, the stimulation will be delivered for one time with a very low current frequency, enough to cause slight tingling, and for 15 seconds long which will also be delivered for 20 minutes, 5 days a week, for 10 days and a total of 10 sessions in 14 days. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Providing an informed consent;
- Literate and between 45-80 years of age;
- 60 females and 60 males;
- Diagnosed with PD based on criteria suggested by UK Parkinson's Disease Society, Brain Bank and PD-MCI in accordance with the diagnostic criteria suggestions by Litvan;
- Diagnosed with aMCI based on diagnosis criteria (CDR\>0.5) suggested by Petersen;
Key exclusion criteria (4 listed)
- Illiterate or education level less than primary school
- Having an existing and/or prior neurological disease; psychiatric disease or head trauma; and/or irreversible hearing or sight problems or other medical illness (e.g. diabetes mellitus, hypertension);
- Exhibiting signs of dementia for PD group ;
- Having medical issues that prevent undergoing fMRI or for tDCS application.
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 |
|---|---|---|
| tDCS0.06mA/cm2 from each electrode with total density of 0.054/cm2 for 20 minutes for 5 days a week, for 10 days and a total of 10 sessions in 14 days. Brain area; DLPFC / LPC | Procedure or surgery | Interventional-DLPFC, Interventional-LPC, Sham |
Primary outcome
Neuropsychological Tests Scores
Time frame: Changes Before Treatment and 14 Days&90 Days after treatment
Moca, AdCom Scores
4 secondary outcomes
EEG Power Spectrum Analysis
Time frame: Changes Before Treatment and 14 Days after treatment
EEG Coherence Analysis
Time frame: Changes Before Treatment and 14 Days after treatment
EEG functional connectivity analysis
Time frame: Changes Before Treatment and 14 Days after treatment
Volumetric Magnetic resonance Imaging (MRI) and functional magnetic resonance imaging (rest-fMRI)
Time frame: Changes Before Treatment and 14 Days after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Alzheimer Disease and Parkinson Disease, run by Istanbul Medipol University Hospital at 1 site 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Burak Yuluğ, Prof. DR. MD (+90 242 510 6135 ext. 3505, burakyulug@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological Tests Scores (time frame: Changes Before Treatment and 14 Days&90 Days after treatment). 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 2 May 2025.