Clinical TrialNCT06562387
tDCS as Adjunctive Therapy to Cognitive Stimulation in Medical Students With Depression
A study testing transcranial direct current stimulation and cognitive stimulation in people with Clinical Trial, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.
Trial summary
Major depressive disorder (MDD) is a major public health problem, it negatively affects cognition and cognitive deficits affect information processing speed, attention, memory, executive function and working memory. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Trial
- What is being tested?
- transcranial direct current stimulation and cognitive stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 22 Jul 2024to 26 Aug 2025
- 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
- Age18 - 30 years old.
- Vaccinated against SARS-COV2 virus.
- Students of the Faculty of Medicine of the UNAM.
- Fluent in Spanish.
- Adequate visual and auditory acuity to be able to perform neuropsychological tests and perform cognitive stimulation.
- Depressive symptoms with working memory impairment (diagnosed by applying a specific neuropsychological battery).
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- That they are not under antidepressant pharmacological treatment prior to admission to the research.
- Good general health without medical illnesses (systemic arterial hypertension, diabetes mellitus, dyslipidemias, infections, thyroid disease, vitamin deficiencies) that do not interfere with the study.
- Willingness to participate in a scheduled 8-week study and able to attend scheduled evaluations.
Who cannot join
- Any neurological disease that allows suspicion of cognitive failure other than depression, such as Parkinson's disease, multiple infarct dementia, Huntington's disease, hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, history of head injury with loss of alertness.
- Participants with history with severe psychiatric disorders according to DSM-5 (bipolar disorder, schizophrenia, chronic depression) or psychotic features, agitation or behavioral problems in the last three months that could lead to difficulties in complying with the protocol.
- History of psychoactive substance abuse and current alcohol use with pattern of abuse or dependence in the past two years.
- Participants with alterations in a conventional electroencephalogram (paroxysmal phenomena identified by a neurophysiologist).
- Participants with pacemakers, intracranial metal objects or history of brain surgery, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Universidad Nacional Autónoma de México
Mexico City, Coyoacan, 04510
About this study
Official title: Transcranial Direct Current Stimulation (tDCS) as Adjunctive Therapy to Cognitive Stimulation in Medical Students With Depression
Major depressive disorder (MDD) is a major public health problem, it negatively affects cognition and cognitive deficits affect information processing speed, attention, memory, executive function and working memory. In addition, cognitive deficits associated with MDD do not resolve after successful treatment of depressive symptoms. In one study, 94% of individuals with MDD and cognitive deficits at the start of treatment retained these deficits one year later, despite achieving clinical remission. Long-term maintenance of antidepressants does not prevent cognition decline, despite maintaining recovery from depression. Cognitive stimulation, has shown the potential to produce broad benefits primarily in working memory. The anodal tDCS increases task-related CPFdl activation. Furthermore, anodal tDCS on CPFdl has been shown to facilitate working memory processes, making tDCS a promising tool for the amelioration of depression-induced working memory impairment in a population with a high prevalence of depression and/or stress, such as medical school students.
Research question: Is Cognitive Stimulation (CS) + active tDCS in CPFdl more effective compared to sham CS+ tDCS in improving on working memory test scores, cognitive functioning, P300 cognitive evoked potentials and academic performance in medical students with depressive symptomatology? Aims: To evaluate the effect of active CE + tDCS in CPFdl to improve scores on tests of working memory, cognitive functioning, P300 cognitive evoked potentials and academic performance in medical students with depressive symptomatology vs sham CE + tDCS.
Materials and Methods: This is a single-blind, comparative (cognitive stimulation + active tDCS vs cognitive stimulation + simulated tDCS), randomized, longitudinal and prolective clinical trial. Analysis: A descriptive analysis of demographic and clinical characteristics will be performed with frequencies and percentages for categorical variables and with means and standard deviations for dimensional variables. Mean comparison tests (t-tests), analysis of variance (ANOVA) and correlation tests. Significance level p≤0.05.
Read the detailed description
Cognitive training has demonstrated the potential to produce broad benefits in functional cognitive. As a fundamental and essential cognitive skill and essential, working memory supports complex thinking, but has limited capacity. Therefore, working memory training interventions have become popular as a means of potentially improve cognitive skills related to working memory for those who need it (Au et al.,2016) Transcranial direct current stimulation is one of the most widely studied techniques in neuromodulation non-invasive neuromodulation. With a very good safety profile and low cost, it has been widely used to modulate cognition and behavior in both experimental and clinical settings A growing body of literature, including randomized controlled trials, reports the clinical benefits of tDCS for many clinical benefits of tDCS for many psychiatric symptoms, such as depression, anxiety, psychosis, addiction, and cognitive function. tDCS has considerable potential as a treatment because of its relative cost, portability, safety, and ease of use compared with other neuromodulation methods. Early studies evaluated the effects of tDCS on the motor cortex; although more recent research has also focused on its effects on the dorsolateral prefrontal cortex (DLPFC), particularly for treating psychiatric disorders and modulating cognitive performance.
Side effects, such as itching, burning sensation or headache are common, but generally mild and without long-term impact.
Therefore, tDCS compares favorably with other therapeutic approaches such as antidepressants or transcranial magnetic simulation (TMS).
Transcranial direct current stimulation (tDCS), which has shown potential to modulate cortical excitability and cortical activity of the brain, by transmitting a weak electrical current to the brain, has been found as a possible way to improve working memory, sustained attention, motor learning, multitasking. Therefore, cognitive enhancement through tDCS has attracted increased attention over the last decade. A considerable number of single-session studies using tDCS have studies using tDCS have revealed potential benefits for improving participants' performance on working memory tasks. In a particularly anodal tDCS (a-tDCS) applied to the left dorsolateral prefrontal cortex, increased accuracy of response of the working memory task performed at the same time as the stimulation. However, no significant effect appeared when they applied anodal stimulation to the primary motor cortex and cathodal stimulation to the primary motor cortex and cathodal stimulation on the left CPFdl. These findings indicate that the potentiating effect of tDCS on working memory recall depends on the polarity of stimulation and is specific to the site of stimulation . Many subsequent studies compared factors such as electrode placement electrode placement, current density, and duration of stimulation that may affect the efficacy of tDCS and found that anodal stimulation of the left prefrontal tended to improve MT performance. Neuroimaging studies utilizing EEG and functional near-infrared spectroscopy (fNIRS) have provided evidence that tDCS may alter brain activities. In addition to studies related to working memory, tDCS has also shown potential to mitigate decreased vigilance and improve multitasking performance.
Based on the assumption that tDCS has the potential to modulate neuronal excitability and synaptic plasticity, several studies have explored the effect of tDCS on training cognitive training in the last 3 years. One study in a non-human primate model found that tDCS, together with multi-session learning, facilitated associative learning and altered functional connectivity when analyzing behavioral outcomes and local field potential. In a study of three-session working memory training, implemented in healthy adults, the advantage of working memory training combined with a working memory training combined with a-tDCS was not only present immediately following training, but also in the follow-up session up to 9 months after training. The benefits related to A-tDCS remained stable even up to one year after the original intervention, in a study of working memory training paired with 7-day tDCS in healthy young adults. Improved cortical efficiency and connectivity was also demonstrated in a study that found a significant improvement in cortical working memory through working memory training paired to -tDCS in healthy young adults.
A recent study in monkeys provided evidence that single-neuron activation rates and network interactions could be be modulated by polarity, and a dose of tDCS and a higher intensity of a-tDCS induced higher activation rates of regularly firing neurons. Although some reviews questioned the efficacy of tDCS, these recently published studies provide further evidence that working memory training combined with tDCS working memory training combined with tDCS can enhance cognition.
Patients with depression exhibit cognitive deficits in several domains (i.e., psychomotor speed, executive functions, memory, and attention), factors such as severity of depression are associated with greater cognitive deficits and lower remission rates, even after antidepressant treatment. These issues highlight the importance of investigating cognitive deficits in major depressive disorder.
However, only a few studies have investigated the brain mechanism underlying the effects of tDCS on cognition effects of tDCS on cognitive processing, with P300. Thus, the present project contributes in to propose a new treatment alternative for cognitive symptoms in MDD, to assist the pharmacological treatment, in addition to an early detection in terms of prevention of cognitive deterioration, providing new cognitive impairment, providing new tools for the diagnostic approach and management of this entity.
HYPOTHESIS Personalized cognitive stimulation in conjunction with transcranial direct current stimulation tDCS will be more effective compared to personalized cognitive stimulation + tDCS-placebo or sham in improving scores on neuropsychological neuropsychological test scores on the cognitive variables to be studied, cognitive potentials P300 and academic performance in UNAM medical students with depressive symptoms at 15 treatment sessions (acute phase) and at 15 sessions of treatment (acute phase) and at 4 weeks of maintenance.
After cognitive stimulation and tDCS, it is expected that in the experimental group the amplitude will be greater in the P300 component since the P300 component ncreased mastery of attention and working memory processes.
- Conditions
- Clinical Trial
- Being tested
- transcranial direct current stimulation, cognitive stimulation, sham transcranial direct current stimulation
- Keywords
- transcranial direct current stimulation, major depressive disorder, cognitive stimulation, Cognitive evoked potentials P300, cognitive impairment
- Medical subject headings
- Depressive Disorder, Major, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
Transcranial direct current stimulation is one of the most studied techniques in noninvasive neuromodulation. With a very good safety profile and low cost, it has been widely used to modulate cognition and behavior in both experimental and clinical settings. A growing body of literature, including randomized controlled trials, reports the clinical benefits of tDCS for many psychiatric symptoms, such as depression, anxiety, psychosis, addiction, and cognitive functions. tDCS has considerable potential as a treatment due to its relative cost, portability, safety, and ease of use compared to other neuromodulation methods. Early studies evaluated the effects of tDCS on the motor cortex; however, more recent research has also focused on its effects on the dorsolateral prefrontal cortex (DLPFC), in particular for treating psychiatric disorders and modulating cognitive performance.
cognitive stimulationOther
This brain stimulation program is based on cognitive reserve and neuronal plasticity to improve mental performance through online games. The activities presented in this tool combine different therapeutic exercises, rehabilitation and learning techniques aimed at retraining and improving the skills most needed by each person. The intervention battery has multi-disciplinary tasks organized in a systematic and strategic way. To make these materials accessible, they are presented in the form of simple games that can be easily practiced through any computer or device. These cognitive stimulation tools are aimed at both healthy subjects and people concerned about their brain health, or patients with some kind of injury or decline in the central nervous system.
sham transcranial direct current stimulationDevice
Regarding the simulated condition or sham, the equipment has the option inside to program it. It gives the options: Active / sham protocol, by default: ON - enables active stimulation and OFF - enables sham stimulation. The devices will be programmed, such that a few seconds of stimulation are administered at the beginning and end of the programmed time period to mimic the cutaneous perceptions (itching, tingling) that tend to be reported within the first few moments of stimulator on, without being able to modify cortical excitability.
| Study group | Role | What they receive |
|---|---|---|
| 1. tDCS active | Active comparator | Cognitive Stimulation + tDCS active in the Dorsolateral Prefrontal Cortex (Dorsolateral Prefrontal Cortex) to improve scores on tests of cognitive functioning (attention, memory, coordination, perception, reasoning and processing speed) and P300 cognitive evoked potentials. Receives: Device: transcranial direct current stimulation; Other: cognitive stimulation |
| 2. sham tDCS | Sham comparator | Cognitive Stimulation + sham tDCS in the Dorsolateral Prefrontal Cortex (Dorsolateral Prefrontal Cortex) to improve scores on cognitive functioning tests (attention, memory, coordination, perception, reasoning and processing speed), and evoked potentials P300 Receives: Other: cognitive stimulation; Device: sham transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare performance on Cognitive improvement (Montreal Cognitive Assessment) between active and sham tDCS groups
remain the same or increase by 1 point on the Montreal Cognitive Assessment. MoCa assesses seven areas of cognition for a total possible score of 30 points. A score of 25 or less is indicative of cognitive impairment.
Measured: three months
To compare performance on neuropsychological battery between active and sham tDCS groups
To compare performance on neuropsychological battery (Brief Visuospatial Memory Test, Stroop color test, Stroop color-word test, Trail Making Test-Part A and Part B, Verbal Learning Memory Test, Wisconsin Card Sorting Test, Weschler Memory Scale) between active and sham tDCS groups. To assess global cognition at each time point, we calculated a composite score by averaging the Z scores from these outcome measures. The mean and SD of the baseline scores were used to calculate Z scores both at baseline and at follow up time points.
Measured: three months
Secondary outcomes (1)
To compare Electrophysiological improvement on P300 between active and sham tDCS groups
increase P300 amplitude from the seventh stimulus onwards *p>0.05
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start22 Jul 2024
- Primary completion12 Dec 2024 (estimated)
- Study completion26 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Clinical TrialStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-blind, comparative clinical trial (cognitive stimulation + active tDCS vs. cognitive stimulation + sham tDCS). Randomization will be carried out with a list of numbers in Excel that will be in charge of one of the members of the research who will not have contact with the participants. The applicators of the stimulation techniques will be the same as those who evaluate and will not remain blind to the maneuver, unlike the students. All the applicators will be randomized to form the two groups and the applicator of the techniques will know whether it is the experimental maneuver or the placebo maneuver.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Autonoma de Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana Guizar, Universidad Nacional Autonoma de Mexico
- Investigators
- Diana Patricia Guízar Sánchez, PhD, Principal investigator, Universidad Nacional Autonoma de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562387
- Sponsor's protocol ID
- FM/DI/56/2021
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participan data available
Publications
Begemann MJ, Brand BA, Curcic-Blake B, Aleman A, Sommer IE. Efficacy of non-invasive brain stimulation on cognitive functioning in brain disorders: a meta-analysis. Psychol Med. 2020 Nov;50(15):2465-2486. doi: 10.1017/S0033291720003670. Epub 2020 Oct 19.
PubMed 33070785Chase HW, Boudewyn MA, Carter CS, Phillips ML. Transcranial direct current stimulation: a roadmap for research, from mechanism of action to clinical implementation. Mol Psychiatry. 2020 Feb;25(2):397-407. doi: 10.1038/s41380-019-0499-9. Epub 2019 Aug 27.
PubMed 31455860Jog MV, Wang DJJ, Narr KL. A review of transcranial direct current stimulation (tDCS) for the individualized treatment of depressive symptoms. Pers Med Psychiatry. 2019 Nov-Dec;17-18:17-22. doi: 10.1016/j.pmip.2019.03.001. Epub 2019 May 7.
PubMed 31938757Jin J, Al-Shamali HF, McWeeny R, Sawalha J, Shalaby R, Marshall T, Greenshaw AJ, Cao B, Zhang Y, Demas M, Dursun SM, Dennett L, Suleman R. Effects of Transcranial Direct Current Stimulation on Cognitive Deficits in Depression: A Systematic Review. Psychiatry Clin Psychopharmacol. 2023 Dec 1;33(4):330-343. doi: 10.5152/pcp.2023.22583. eCollection 2023 Dec.
PubMed 38765850
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) as Adjunctive Therapy to Cognitive Stimulation in Medical Students With Depression
- ClinicalTrials.gov ID
- NCT06562387
- Acronym / sponsor ID
- FM/DI/56/2021
- Conditions
- Clinical Trial
- Keywords
- transcranial direct current stimulation, major depressive disorder, cognitive stimulation, Cognitive evoked potentials P300, cognitive impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad Nacional Autonoma de MexicoUniversity, hospital or other
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 12 Dec 2024 (estimated)
- Study completion
- 26 Aug 2025 (estimated)
- First posted
- 20 Aug 2024 (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.
Major depressive disorder (MDD) is a major public health problem, it negatively affects cognition and cognitive deficits affect information processing speed, attention, memory, executive function and working memory. In addition, cognitive deficits associated with MDD do not resolve after successful treatment of depressive symptoms. In one study, 94% of individuals with MDD and cognitive deficits at the start of treatment retained these deficits one year later, despite achieving clinical remission. Long-term maintenance of antidepressants does not prevent cognition decline, despite maintaining recovery from depression. Cognitive stimulation, has shown the potential to produce broad benefits primarily in working memory. The anodal tDCS increases task-related CPFdl activation. Furthermore, anodal tDCS on CPFdl has been shown to facilitate working memory processes, making tDCS a promising tool for the amelioration of depression-induced working memory impairment in a population with a high prevalence of depression and/or stress, such as medical school students.
Research question: Is Cognitive Stimulation (CS) + active tDCS in CPFdl more effective compared to sham CS+ tDCS in improving on working memory test scores, cognitive functioning, P300 cognitive evoked potentials and academic performance in medical students with depressive symptomatology? Aims: To evaluate the effect of active CE + tDCS in CPFdl to improve scores on tests of working memory, cognitive functioning, P300 cognitive evoked potentials and academic performance in medical students with depressive symptomatology vs sham CE + tDCS.
Materials and Methods: This is a single-blind, comparative (cognitive stimulation + active tDCS vs cognitive stimulation + simulated tDCS), randomized, longitudinal and prolective clinical trial. Analysis: A descriptive analysis of demographic and clinical characteristics will be performed with frequencies and percentages for categorical variables and with means and standard deviations for dimensional variables. Mean comparison tests (t-tests), analysis of variance (ANOVA) and correlation tests. Significance level p≤0.05.
Detailed description
Cognitive training has demonstrated the potential to produce broad benefits in functional cognitive. As a fundamental and essential cognitive skill and essential, working memory supports complex thinking, but has limited capacity. Therefore, working memory training interventions have become popular as a means of potentially improve cognitive skills related to working memory for those who need it (Au et al.,2016) Transcranial direct current stimulation is one of the most widely studied techniques in neuromodulation non-invasive neuromodulation. With a very good safety profile and low cost, it has been widely used to modulate cognition and behavior in both experimental and clinical settings A growing body of literature, including randomized controlled trials, reports the clinical benefits of tDCS for many clinical benefits of tDCS for many psychiatric symptoms, such as depression, anxiety, psychosis, addiction, and cognitive function. tDCS has considerable potential as a treatment because of its relative cost, portability, safety, and ease of use compared with other neuromodulation methods. Early studies evaluated the effects of tDCS on the motor cortex; although more recent research has also focused on its effects on the dorsolateral prefrontal cortex (DLPFC), particularly for treating psychiatric disorders and modulating cognitive performance.
Side effects, such as itching, burning sensation or headache are common, but generally mild and without long-term impact.
Therefore, tDCS compares favorably with other therapeutic approaches such as antidepressants or transcranial magnetic simulation (TMS).
Transcranial direct current stimulation (tDCS), which has shown potential to modulate cortical excitability and cortical activity of the brain, by transmitting a weak electrical current to the brain, has been found as a possible way to improve working memory, sustained attention, motor learning, multitasking. Therefore, cognitive enhancement through tDCS has attracted increased attention over the last decade. A considerable number of single-session studies using tDCS have studies using tDCS have revealed potential benefits for improving participants' performance on working memory tasks. In a particularly anodal tDCS (a-tDCS) applied to the left dorsolateral prefrontal cortex, increased accuracy of response of the working memory task performed at the same time as the stimulation. However, no significant effect appeared when they applied anodal stimulation to the primary motor cortex and cathodal stimulation to the primary motor cortex and cathodal stimulation on the left CPFdl. These findings indicate that the potentiating effect of tDCS on working memory recall depends on the polarity of stimulation and is specific to the site of stimulation . Many subsequent studies compared factors such as electrode placement electrode placement, current density, and duration of stimulation that may affect the efficacy of tDCS and found that anodal stimulation of the left prefrontal tended to improve MT performance. Neuroimaging studies utilizing EEG and functional near-infrared spectroscopy (fNIRS) have provided evidence that tDCS may alter brain activities. In addition to studies related to working memory, tDCS has also shown potential to mitigate decreased vigilance and improve multitasking performance.
Based on the assumption that tDCS has the potential to modulate neuronal excitability and synaptic plasticity, several studies have explored the effect of tDCS on training cognitive training in the last 3 years. One study in a non-human primate model found that tDCS, together with multi-session learning, facilitated associative learning and altered functional connectivity when analyzing behavioral outcomes and local field potential. In a study of three-session working memory training, implemented in healthy adults, the advantage of working memory training combined with a working memory training combined with a-tDCS was not only present immediately following training, but also in the follow-up session up to 9 months after training. The benefits related to A-tDCS remained stable even up to one year after the original intervention, in a study of working memory training paired with 7-day tDCS in healthy young adults. Improved cortical efficiency and connectivity was also demonstrated in a study that found a significant improvement in cortical working memory through working memory training paired to -tDCS in healthy young adults.
A recent study in monkeys provided evidence that single-neuron activation rates and network interactions could be be modulated by polarity, and a dose of tDCS and a higher intensity of a-tDCS induced higher activation rates of regularly firing neurons. Although some reviews questioned the efficacy of tDCS, these recently published studies provide further evidence that working memory training combined with tDCS working memory training combined with tDCS can enhance cognition.
Patients with depression exhibit cognitive deficits in several domains (i.e., psychomotor speed, executive functions, memory, and attention), factors such as severity of depression are associated with greater cognitive deficits and lower remission rates, even after antidepressant treatment. These issues highlight the importance of investigating cognitive deficits in major depressive disorder.
However, only a few studies have investigated the brain mechanism underlying the effects of tDCS on cognition effects of tDCS on cognitive processing, with P300. Thus, the present project contributes in to propose a new treatment alternative for cognitive symptoms in MDD, to assist the pharmacological treatment, in addition to an early detection in terms of prevention of cognitive deterioration, providing new cognitive impairment, providing new tools for the diagnostic approach and management of this entity.
HYPOTHESIS Personalized cognitive stimulation in conjunction with transcranial direct current stimulation tDCS will be more effective compared to personalized cognitive stimulation + tDCS-placebo or sham in improving scores on neuropsychological neuropsychological test scores on the cognitive variables to be studied, cognitive potentials P300 and academic performance in UNAM medical students with depressive symptoms at 15 treatment sessions (acute phase) and at 15 sessions of treatment (acute phase) and at 4 weeks of maintenance.
After cognitive stimulation and tDCS, it is expected that in the experimental group the amplitude will be greater in the P300 component since the P300 component ncreased mastery of attention and working memory processes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- single-blind, comparative clinical trial (cognitive stimulation + active tDCS vs. cognitive stimulation + sham tDCS). Randomization will be carried out with a list of numbers in Excel that will be in charge of one of the members of the research who will not have contact with the participants. The applicators of the stimulation techniques will be the same as those who evaluate and will not remain blind to the maneuver, unlike the students. All the applicators will be randomized to form the two groups and the applicator of the techniques will know whether it is the experimental maneuver or the placebo maneuver.
| Arm | Type | Receives |
|---|---|---|
| 1. tDCS active | Active comparator | Device: transcranial direct current stimulation, Other: cognitive stimulationCognitive Stimulation + tDCS active in the Dorsolateral Prefrontal Cortex (Dorsolateral Prefrontal Cortex) to improve scores on tests of cognitive functioning (attention, memory, coordination, perception, reasoning and processing speed) and P300 cognitive evoked potentials. |
| 2. sham tDCS | Sham comparator | Other: cognitive stimulation, Device: sham transcranial direct current stimulationCognitive Stimulation + sham tDCS in the Dorsolateral Prefrontal Cortex (Dorsolateral Prefrontal Cortex) to improve scores on cognitive functioning tests (attention, memory, coordination, perception, reasoning and processing speed), and evoked potentials P300 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age18 - 30 years old.
- Vaccinated against SARS-COV2 virus.
- Students of the Faculty of Medicine of the UNAM.
- Fluent in Spanish.
- Adequate visual and auditory acuity to be able to perform neuropsychological tests and perform cognitive stimulation.
Key exclusion criteria (5 listed)
- Any neurological disease that allows suspicion of cognitive failure other than depression, such as Parkinson's disease, multiple infarct dementia, Huntington's disease, hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, history of head injury with loss of alertness.
- Participants with history with severe psychiatric disorders according to DSM-5 (bipolar disorder, schizophrenia, chronic depression) or psychotic features, agitation or behavioral problems in the last three months that could lead to difficulties in complying with the protocol.
- History of psychoactive substance abuse and current alcohol use with pattern of abuse or dependence in the past two years.
- Participants with alterations in a conventional electroencephalogram (paroxysmal phenomena identified by a neurophysiologist).
- Participants with pacemakers, intracranial metal objects or history of brain surgery, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body.
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 stimulationTranscranial direct current stimulation is one of the most studied techniques in noninvasive neuromodulation. With a very good safety profile and low cost, it has been widely used to modulate cognition and behavior in both experimental and clinical settings. A growing body of literature, including randomized controlled trials, reports the clinical benefits of tDCS for many psychiatric symptoms, such as depression, anxiety, psychosis, addiction, and cognitive functions. tDCS has considerable potential as a treatment due to its relative cost, portability, safety, and ease of use compared to other neuromodulation methods. Early studies evaluated the effects of tDCS on the motor cortex; however, more recent research has also focused on its effects on the dorsolateral prefrontal cortex (DLPFC), in particular for treating psychiatric disorders and modulating cognitive performance. | Device | 1. tDCS active |
| cognitive stimulationThis brain stimulation program is based on cognitive reserve and neuronal plasticity to improve mental performance through online games. The activities presented in this tool combine different therapeutic exercises, rehabilitation and learning techniques aimed at retraining and improving the skills most needed by each person. The intervention battery has multi-disciplinary tasks organized in a systematic and strategic way. To make these materials accessible, they are presented in the form of simple games that can be easily practiced through any computer or device. These cognitive stimulation tools are aimed at both healthy subjects and people concerned about their brain health, or patients with some kind of injury or decline in the central nervous system. | Other | 1. tDCS active, 2. sham tDCS |
| sham transcranial direct current stimulationRegarding the simulated condition or sham, the equipment has the option inside to program it. It gives the options: Active / sham protocol, by default: ON - enables active stimulation and OFF - enables sham stimulation. The devices will be programmed, such that a few seconds of stimulation are administered at the beginning and end of the programmed time period to mimic the cutaneous perceptions (itching, tingling) that tend to be reported within the first few moments of stimulator on, without being able to modify cortical excitability. | Device | 2. sham tDCS |
Primary outcome
To compare performance on Cognitive improvement (Montreal Cognitive Assessment) between active and sham tDCS groups
Time frame: three months
remain the same or increase by 1 point on the Montreal Cognitive Assessment. MoCa assesses seven areas of cognition for a total possible score of 30 points. A score of 25 or less is indicative of cognitive impairment.
To compare performance on neuropsychological battery between active and sham tDCS groups
Time frame: three months
To compare performance on neuropsychological battery (Brief Visuospatial Memory Test, Stroop color test, Stroop color-word test, Trail Making Test-Part A and Part B, Verbal Learning Memory Test, Wisconsin Card Sorting Test, Weschler Memory Scale) between active and sham tDCS groups. To assess global cognition at each time point, we calculated a composite score by averaging the Z scores from these outcome measures. The mean and SD of the baseline scores were used to calculate Z scores both at baseline and at follow up time points.
1 secondary outcome
To compare Electrophysiological improvement on P300 between active and sham tDCS groups
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Background: PubMed 33070785Begemann MJ, Brand BA, Curcic-Blake B, Aleman A, Sommer IE. Efficacy of non-invasive brain stimulation on cognitive functioning in brain disorders: a meta-analysis. Psychol Med. 2020 Nov;50(15):2465-2486. doi: 10.1017/S0033291720003670. Epub 2020 Oct 19.
- Background: PubMed 31455860Chase HW, Boudewyn MA, Carter CS, Phillips ML. Transcranial direct current stimulation: a roadmap for research, from mechanism of action to clinical implementation. Mol Psychiatry. 2020 Feb;25(2):397-407. doi: 10.1038/s41380-019-0499-9. Epub 2019 Aug 27.
- Background: PubMed 31938757Jog MV, Wang DJJ, Narr KL. A review of transcranial direct current stimulation (tDCS) for the individualized treatment of depressive symptoms. Pers Med Psychiatry. 2019 Nov-Dec;17-18:17-22. doi: 10.1016/j.pmip.2019.03.001. Epub 2019 May 7.
- Background: PubMed 38765850Jin J, Al-Shamali HF, McWeeny R, Sawalha J, Shalaby R, Marshall T, Greenshaw AJ, Cao B, Zhang Y, Demas M, Dursun SM, Dennett L, Suleman R. Effects of Transcranial Direct Current Stimulation on Cognitive Deficits in Depression: A Systematic Review. Psychiatry Clin Psychopharmacol. 2023 Dec 1;33(4):330-343. doi: 10.5152/pcp.2023.22583. eCollection 2023 Dec.
- Individual participant dataSharing planned: No. There is not a plan to make individual participan data available
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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.
Diana Patricia Guízar Sánchez, PhD principal investigator
Universidad Nacional Autonoma de Mexico
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 and cognitive stimulation in people with Clinical Trial, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.
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 9 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 20 Aug 2024. 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 Mexico. 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?
To compare performance on Cognitive improvement (Montreal Cognitive Assessment) between active and sham tDCS groups (time frame: three months). 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 NCT06562387, which also lists 4 linked publications.
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 20 Aug 2024.