Mild Cognitive ImpairmentNCT04943003
Study of Neurobiological Predictors of Response to Non-invasive Neurostimulation and Genetic Susceptibility to Dementia in Patients With Amnestic Mild Cognitive Impairment
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Mild Cognitive Impairment, run by Suellen Marinho Andrade at 1 site in Brazil.
Trial summary
Transcranial Direct Current Stimulation is a non-invasive neuromodulatory technique that results in the clinical improvement of patients with Mild Cognitive Impairment, a prodromal condition for the onset of dementia. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Aug 2021to 25 Dec 2024
- 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Individuals diagnosed with Mild Cognitive Impairment (MCI);
- Both sexes;
- Aged 65 years or older, without a diagnosis of dementia will be included.
Who cannot join
- Unstable medical conditions;
- Patients with metallic implants and pacemakers;
- Epileptics;
- Using drugs/alcohol, regular use of hypnotics and benzodiazepines up to two weeks before the start of the study;
- People who have been using medication with cholinergic inhibitors for more than two months before this clinical trial
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Paraíba,Department of Psychology
João Pessoa, Paraíba, 58051-900
About this study
Official title: Neurobiological Predictors of Response to Non-invasive Neurostimulation and Genetic Susceptibility to Dementia in Patients With Amnestic Mild Cognitive Impairment (CCL)
Transcranial Direct Current Stimulation is a non-invasive neuromodulatory technique that results in the clinical improvement of patients with Mild Cognitive Impairment, a prodromal condition for the onset of dementia. The responses to treatment depend on the characteristics of the patients and the parameters adjusted in the equipment, which makes the modeling of electric fields imperative to maximize the safety profile and therapeutic potential of the technique. The study of neurobiological predictors of response to non-invasive neurostimulation and genetic susceptibility can elucidate current effects according to the individual's profile. The objectives of this study are to observe the effects of Transcranial Direct Current Stimulation with optimized/customized parameters in patients with amnestic CCL, considering the subjects' genetic susceptibility to Alzheimer's Disease and neurobiological markers. This is a randomized, triple-blind, sham-controlled clinical trial. Neuropsychological tests and a sociodemographic and clinical questionnaire will be used to assess and characterize the subjects. Participants captured by the Laboratory of Studies in Aging and Neuroscience at the Federal University of Paraíba will be divided into 02 groups, each with 25 patients, totaling 50 volunteers: Active - participants who will receive real current; Sham - participants who will receive simulated stimulation. Participants entered through the eligibility criteria will be randomly allocated in a simple way, at a rate of 1:1. Payment parameters will be customized by Computational Modeling with the aid of the SimNIBS Program and Nuclear Magnetic Resonance. The electroencephalogram and evaluation of polymorphisms of the gene encoding Apolipoprotein E examined as predictors of response. Data will be processed from the Statistical Package for Social Sciences® (20.0) Software, applying the Student test for continuous variables or chi-square for categorical variables. Predictive analysis will be conducted from Machine Learning. It is expected to find improvements in the scores of memory and general cognition tests after the intervention protocol with tDCS with individualized dose in the group that will receive an intervention, compared to the simulated neurostimulation group. These obtained results optimize the practice, elucidating issues still present due to the different applications of the technique produced in the literature on the subject.
Read the detailed description
Neuropsychological tests and a sociodemographic and clinical questionnaire will be used to assess and characterize the subjects. Participants captured by the Laboratory of Studies in Aging and Neuroscience at the Federal University of Paraíba will be divided into 02 groups, each with 25 patients, totaling 50 volunteers: Active - participants who will receive real current; Sham - participants who will receive simulated stimulation. Participants entered through the eligibility criteria will be randomly allocated in a simple way, at a rate of 1:1. Payment parameters will be customized by Computational Modeling with the aid of the SimNIBS Program and Nuclear Magnetic Resonance. The electroencephalogram and evaluation of polymorphisms of the gene encoding Apolipoprotein E examined as predictors of response.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Transcranial Direct Current Stimulation (tDCS)
- Keywords
- Mild Cognitive Impairment, tDCS, Computational modeling
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation (tDCS)Device
Initially, a measuring tape will be used to make the markings and measurements necessary for placing the electrodes.
Regarding neurostimulation, the tDCS device is simple and portable, consisting of four main components: two electrodes (anode and cathode), an ammeter (electric current intensity meter), a potentiometer (voltage controller between electrodes) and a set of batteries. We will use the TCT-Research Neurostimulator, developed by Trans Cranial Technologies (Hong Kong, China), Regarding the protocols, the Active tDCS group will receive active tDCS for 30 minutes and for 5 consecutive days, in two weeks, with an anode positioned on the left DLPFC and a cathode electrode placed on the right supraorbital area. The 10-20 International EEG system will be taken as a reference. The current intensity will be defined from computational modeling, using Nuclear Magnetic Resonance (NMR) to estimate and individualize the dose to be administered.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | SimNIBS will be used for modeling. It is a free and open source software package for the simulation of electric field induced by tDCS in the individual brain.
Modeling will be done using T1-weighted anatomical images of each subject to reconstruct a high-resolution head model of each individual. For electrode placement, we will simulate areas F5 and F6, according to the EEG 10-20 system, for the anode and cathode, respectively, targeting the left and right Dorsolateral Prefrontal Cortex (DLPFC). This group will receive active tDCS, for 30 minutes and for 5 consecutive days, in two weeks, with an anode positioned on the left DLPFC and a cathode electrode placed on the right supraorbital area. Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
| Sham tDCS | Sham comparator | The electrodes will be placed in the same way as in the Active tDCS group. However, individuals in this group will receive a stimulation that will last only 20-30 seconds. Afterwards, the device will be turned off, no longer emitting current. Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Mental State Examination (MMSE) (T0)
To assess the primary outcome, the Mini Mental State Examination (MMSE) o will be used, developed in the United States and published in 1975, whose maximum score is 30 points and includes questions about memory, attention , orientation, language, and visuospatial skills.
We will adopt the 24-point score for the standard cut, following recommendations expressed in the literature. In order to avoid false positives and false negatives, we will perform the stratification by levels or years of schooling, as educational level is the main predictor of MMSE performance.
Authors recorded good internal consistency (0.62 to 0.79) and a high test-retest reliability of the MMSE, ranging from 0.76 to 0.90, being a reliable instrument to detect CCL and AD .
Measured: The evoluations will be carried out in Pre-intervention (T0)
Mini Mental State Examination (MMSE) (T1)
To assess the primary outcome, the Mini Mental State Examination (MMSE) o will be used, developed in the United States and published in 1975, whose maximum score is 30 points and includes questions about memory, attention , orientation, language, and visuospatial skills.
We will adopt the 24-point score for the standard cut, following recommendations expressed in the literature. In order to avoid false positives and false negatives, we will perform the stratification by levels or years of schooling, as educational level is the main predictor of MMSE performance.
Authors recorded good internal consistency (0.62 to 0.79) and a high test-retest reliability of the MMSE, ranging from 0.76 to 0.90, being a reliable instrument to detect CCL and AD .
Measured: The evoluations will be performed up to one week after the stimulation protocol (T1)
Secondary outcomes (9)
Digit Span Memory Test
This is one of the main tasks used in short-term memory assessment, where the examiner asks the patient to repeat a series of numbers (eg 2-5, 3-6-7). The first sequence starts with two digits, and after each correct answer the examiner adds one digit to the next sequence. The test is composed of two parts, in forward and reverse order, allowing the assessment of short-term memory storage capacity and its executive component.
Measured: The evoluations will be carried out in Pre-intervention (T0)
Digit Span Memory Test
This is one of the main tasks used in short-term memory assessment, where the examiner asks the patient to repeat a series of numbers (eg 2-5, 3-6-7). The first sequence starts with two digits, and after each correct answer the examiner adds one digit to the next sequence. The test is composed of two parts, in forward and reverse order, allowing the assessment of short-term memory storage capacity and its executive component.
Measured: The evoluations will be performed up to one week after the stimulation protocol (T1)
Beck Depression Scale II and Beck Anxiety Inventory
The Beck II Depression Scale, a self-report instrument for depression, has 21 items that reveal how the individual has felt during the last two weeks (including the current day), in which there are four answers for each one (with a score ranging from 0 to 3). The total score is the sum of individual items, whose maximum score can reach 63 points, being classified into levels: mild, moderate and severe.
The Beck Anxiety Inventory consists of 21 items that assess how the individual has been feeling during the last two weeks, including the current day, enabling the collection of information about anxiety symptoms. Each item has 4 options, among which one can be chosen by the participant (ranging from 0 to 3 the score of each option). The total score is calculated by adding the individual response for each item, with a maximum score of 63 points. The results will be used as a prediction of response to neurostimulation.
Measured: The evoluations will be carried out in Pre-intervention (T0)
Beck Depression Scale II and Beck Anxiety Inventory
The Beck II Depression Scale, a self-report instrument for depression, has 21 items that reveal how the individual has felt during the last two weeks (including the current day), in which there are four answers for each one (with a score ranging from 0 to 3). The total score is the sum of individual items, whose maximum score can reach 63 points, being classified into levels: mild, moderate and severe.
The Beck Anxiety Inventory consists of 21 items that assess how the individual has been feeling during the last two weeks, including the current day, enabling the collection of information about anxiety symptoms. Each item has 4 options, among which one can be chosen by the participant (ranging from 0 to 3 the score of each option). The total score is calculated by adding the individual response for each item, with a maximum score of 63 points. The results will be used as a prediction of response to neurostimulation.
Measured: The evoluations will be performed up to one week after the stimulation protocol (T1)
Genetic susceptibility (ApoE)
For ApoE allele genotyping, the researchers will follow the recommendations proposed by Crook, Hardy \& Duff (1994) and Wenham, Newton, \& Price (1991), and the genomic DNA will be amplified by a Polymerase Chain Reaction (PCR). The results will be used as a prediction of response to neurostimulation.
Measured: The evoluations will be carried out in Pre-intervention (T0)
Electroencephalography
Brain electrical activity will be captured using the BrainVision actiCHamp32 equipment (Brain vision, Herrsching, Germany), using 32 Ag/AgCl electrodes, which will be positioned and fixed based on the 10-20 International System. The data will be used to assess brain electrical activity at baseline.
Measured: The evoluations will be carried out in Pre-intervention (T0)
Electroencephalography (EEG)
Brain electrical activity will be captured using the BrainVision actiCHamp32 equipment (Brain vision, Herrsching, Germany), using 32 Ag/AgCl electrodes, which will be positioned and fixed based on the 10-20 International System. The regions of interest to be monitored are: prefrontal, frontal, parietal, temporal and occipital region, bilaterally (Fz, F3, F7, FT9, FC5, FC1, C3, T7, TP9, CP5, CP1, Pz, P3, P7, O1, Oz, O2, P4, P8, TP10, CP6, CP2, Cz, C4, T8, FT10, FC6, FC2, F4, F8, Fp2, Fp1), in the silent condition in the eyes and eyes closed states , for five minutes each, totaling 10 minutes of collection for each subject. The results will be used as a prediction of response to neurostimulation.
Measured: The evoluations will be performed up to one week after the stimulation protocol (T1)
Magnetic Resonance Imaging-MRI
High-resolution anatomical images will be acquired using a T1-weighted fast gradient sequence prepared by three-dimensional magnetization with the following parameters: repetition time (TR) = 1900ms, echo time (TE) = 2.2 ms, inversion time (TI) = 900 ms, inversion angle (FA) = 9°, number of slices = 176, slice thickness = 1 mm, voxel size = 1 × 1 × 1 mm 3 and matrix = 256 × 256. The results will be used for computational modeling and to assess brain electrical activity at baseline.
Measured: The evoluations will be carried out in Pre-intervention (T0)
Magnetic Resonance Imaging-MRI
High-resolution anatomical images will be acquired using a T1-weighted fast gradient sequence prepared by three-dimensional magnetization with the following parameters: repetition time (TR) = 1900ms, echo time (TE) = 2.2 ms, inversion time (TI) = 900 ms, inversion angle (FA) = 9°, number of slices = 176, slice thickness = 1 mm, voxel size = 1 × 1 × 1 mm 3 and matrix = 256 × 256. The results will be used as a prediction of response to neurostimulation.
Measured: The evoluations will be performed up to one week after the stimulation protocol (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start26 Aug 2021 (estimated)
- Primary completion25 Dec 2022 (estimated)
- Study completion25 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Model description
- Participants will be divided into 02 groups, each with 25 patients, totaling 50 volunteers: Active - participants who will receive real current; Sham - participants who will receive simulated stimulation. Participants entered into the study through the eligibility criteria will be randomly allocated in a simple way, at a rate of 1:1.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suellen Marinho Andrade
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Suellen Marinho Andrade, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943003
- Sponsor's protocol ID
- tDCS in MCI
- Status last verified
- Jul 2021
- First submitted
- 6 Jun 2021
- Last updated
- 27 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alexandrino KALG, de Aquino AMI, de Melo SD, de Andrade Cesar MB, Motta AR, Weller M, Galisa SLG, de Faria JR, Dos Santos Andrade SMM. Effects of transcranial direct current stimulation on cognition, depression, and brain activity in a breast-cancer survivor: a case report. J Med Case Rep. 2026 Apr 25;20(1):319. doi: 10.1186/s13256-026-06061-4.
PubMed 42032764
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiological Predictors of Response to Non-invasive Neurostimulation and Genetic Susceptibility to Dementia in Patients With Amnestic Mild Cognitive Impairment (CCL)
- ClinicalTrials.gov ID
- NCT04943003
- Acronym / sponsor ID
- tDCS in MCI
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, tDCS, Computational modeling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Suellen Marinho AndradeUniversity, hospital or other
- Study start
- 26 Aug 2021 (estimated)
- Primary completion
- 25 Dec 2022 (estimated)
- Study completion
- 25 Dec 2024 (estimated)
- First posted
- 29 Jun 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.
Transcranial Direct Current Stimulation is a non-invasive neuromodulatory technique that results in the clinical improvement of patients with Mild Cognitive Impairment, a prodromal condition for the onset of dementia. The responses to treatment depend on the characteristics of the patients and the parameters adjusted in the equipment, which makes the modeling of electric fields imperative to maximize the safety profile and therapeutic potential of the technique. The study of neurobiological predictors of response to non-invasive neurostimulation and genetic susceptibility can elucidate current effects according to the individual's profile. The objectives of this study are to observe the effects of Transcranial Direct Current Stimulation with optimized/customized parameters in patients with amnestic CCL, considering the subjects' genetic susceptibility to Alzheimer's Disease and neurobiological markers. This is a randomized, triple-blind, sham-controlled clinical trial. Neuropsychological tests and a sociodemographic and clinical questionnaire will be used to assess and characterize the subjects. Participants captured by the Laboratory of Studies in Aging and Neuroscience at the Federal University of Paraíba will be divided into 02 groups, each with 25 patients, totaling 50 volunteers: Active - participants who will receive real current; Sham - participants who will receive simulated stimulation. Participants entered through the eligibility criteria will be randomly allocated in a simple way, at a rate of 1:1. Payment parameters will be customized by Computational Modeling with the aid of the SimNIBS Program and Nuclear Magnetic Resonance. The electroencephalogram and evaluation of polymorphisms of the gene encoding Apolipoprotein E examined as predictors of response. Data will be processed from the Statistical Package for Social Sciences® (20.0) Software, applying the Student test for continuous variables or chi-square for categorical variables. Predictive analysis will be conducted from Machine Learning. It is expected to find improvements in the scores of memory and general cognition tests after the intervention protocol with tDCS with individualized dose in the group that will receive an intervention, compared to the simulated neurostimulation group. These obtained results optimize the practice, elucidating issues still present due to the different applications of the technique produced in the literature on the subject.
Detailed description
Neuropsychological tests and a sociodemographic and clinical questionnaire will be used to assess and characterize the subjects. Participants captured by the Laboratory of Studies in Aging and Neuroscience at the Federal University of Paraíba will be divided into 02 groups, each with 25 patients, totaling 50 volunteers: Active - participants who will receive real current; Sham - participants who will receive simulated stimulation. Participants entered through the eligibility criteria will be randomly allocated in a simple way, at a rate of 1:1. Payment parameters will be customized by Computational Modeling with the aid of the SimNIBS Program and Nuclear Magnetic Resonance. The electroencephalogram and evaluation of polymorphisms of the gene encoding Apolipoprotein E examined as predictors of response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be divided into 02 groups, each with 25 patients, totaling 50 volunteers: Active - participants who will receive real current; Sham - participants who will receive simulated stimulation. Participants entered into the study through the eligibility criteria will be randomly allocated in a simple way, at a rate of 1:1.
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: Transcranial Direct Current Stimulation (tDCS)SimNIBS will be used for modeling. It is a free and open source software package for the simulation of electric field induced by tDCS in the individual brain. Modeling will be done using T1-weighted anatomical images of each subject to reconstruct a high-resolution head model of each individual. For electrode placement, we will simulate areas F5 and F6, according to the EEG 10-20 system, for the anode and cathode, respectively, targeting the left and right Dorsolateral Prefrontal Cortex (DLPFC). This group will receive active tDCS, for 30 minutes and for 5 consecutive days, in two weeks, with an anode positioned on the left DLPFC and a cathode electrode placed on the right supraorbital area. |
| Sham tDCS | Sham comparator | Device: Transcranial Direct Current Stimulation (tDCS)The electrodes will be placed in the same way as in the Active tDCS group. However, individuals in this group will receive a stimulation that will last only 20-30 seconds. Afterwards, the device will be turned off, no longer emitting current. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Individuals diagnosed with Mild Cognitive Impairment (MCI);
- Both sexes;
- Aged 65 years or older, without a diagnosis of dementia will be included.
Key exclusion criteria (5 listed)
- Unstable medical conditions;
- Patients with metallic implants and pacemakers;
- Epileptics;
- Using drugs/alcohol, regular use of hypnotics and benzodiazepines up to two weeks before the start of the study;
- People who have been using medication with cholinergic inhibitors for more than two months before this clinical trial
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 Stimulation (tDCS)Initially, a measuring tape will be used to make the markings and measurements necessary for placing the electrodes. Regarding neurostimulation, the tDCS device is simple and portable, consisting of four main components: two electrodes (anode and cathode), an ammeter (electric current intensity meter), a potentiometer (voltage controller between electrodes) and a set of batteries. We will use the TCT-Research Neurostimulator, developed by Trans Cranial Technologies (Hong Kong, China), Regarding the protocols, the Active tDCS group will receive active tDCS for 30 minutes and for 5 consecutive days, in two weeks, with an anode positioned on the left DLPFC and a cathode electrode placed on the right supraorbital area. The 10-20 International EEG system will be taken as a reference. The current intensity will be defined from computational modeling, using Nuclear Magnetic Resonance (NMR) to estimate and individualize the dose to be administered. | Device | Active tDCS, Sham tDCS |
Primary outcome
Mini Mental State Examination (MMSE) (T0)
Time frame: The evoluations will be carried out in Pre-intervention (T0)
To assess the primary outcome, the Mini Mental State Examination (MMSE) o will be used, developed in the United States and published in 1975, whose maximum score is 30 points and includes questions about memory, attention , orientation, language, and visuospatial skills. We will adopt the 24-point score for the standard cut, following recommendations expressed in the literature. In order to avoid false positives and false negatives, we will perform the stratification by levels or years of schooling, as educational level is the main predictor of MMSE performance. Authors recorded good internal consistency (0.62 to 0.79) and a high test-retest reliability of the MMSE, ranging from 0.76 to 0.90, being a reliable instrument to detect CCL and AD .
Mini Mental State Examination (MMSE) (T1)
Time frame: The evoluations will be performed up to one week after the stimulation protocol (T1)
To assess the primary outcome, the Mini Mental State Examination (MMSE) o will be used, developed in the United States and published in 1975, whose maximum score is 30 points and includes questions about memory, attention , orientation, language, and visuospatial skills. We will adopt the 24-point score for the standard cut, following recommendations expressed in the literature. In order to avoid false positives and false negatives, we will perform the stratification by levels or years of schooling, as educational level is the main predictor of MMSE performance. Authors recorded good internal consistency (0.62 to 0.79) and a high test-retest reliability of the MMSE, ranging from 0.76 to 0.90, being a reliable instrument to detect CCL and AD .
9 secondary outcomes
Digit Span Memory Test
Time frame: The evoluations will be carried out in Pre-intervention (T0)
Digit Span Memory Test
Time frame: The evoluations will be performed up to one week after the stimulation protocol (T1)
Beck Depression Scale II and Beck Anxiety Inventory
Time frame: The evoluations will be carried out in Pre-intervention (T0)
Beck Depression Scale II and Beck Anxiety Inventory
Time frame: The evoluations will be performed up to one week after the stimulation protocol (T1)
Genetic susceptibility (ApoE)
Time frame: The evoluations will be carried out in Pre-intervention (T0)
Electroencephalography
Time frame: The evoluations will be carried out in Pre-intervention (T0)
Electroencephalography (EEG)
Time frame: The evoluations will be performed up to one week after the stimulation protocol (T1)
Magnetic Resonance Imaging-MRI
Time frame: The evoluations will be carried out in Pre-intervention (T0)
Magnetic Resonance Imaging-MRI
Time frame: The evoluations will be performed up to one week after the stimulation protocol (T1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Derived from this study: PubMed 42032764Alexandrino KALG, de Aquino AMI, de Melo SD, de Andrade Cesar MB, Motta AR, Weller M, Galisa SLG, de Faria JR, Dos Santos Andrade SMM. Effects of transcranial direct current stimulation on cognition, depression, and brain activity in a breast-cancer survivor: a case report. J Med Case Rep. 2026 Apr 25;20(1):319. doi: 10.1186/s13256-026-06061-4.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 (tDCS) in people with Mild Cognitive Impairment, run by Suellen Marinho Andrade at 1 site in Brazil.
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 3 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: status not confirmed, as of the sponsor's last update on 27 Jul 2021. 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 Brazil. 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?
Results are not available in the source record.
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?
Mini Mental State Examination (MMSE) (T0) (time frame: The evoluations will be carried out in Pre-intervention (T0)). 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?
On the ClinicalTrials.gov record for NCT04943003, which also lists 1 linked publication.
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 27 Jul 2021.