tDCS as Adjunctive Therapy to Cognitive Stimulation in Medical Students With Depression

NCT06562387 | Active Not Recruiting DMC

• 1 other identifier: FM/DI/56/2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Clinical Trial

Keywords

transcranial direct current stimulation; major depressive disorder; cognitive stimulation; Cognitive evoked potentials P300; cognitive impairment

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  three months

Secondary Outcomes (1)

• To compare Electrophysiological improvement on P300 between active and sham tDCS groups

  three months

Other Outcomes (1)

• Global improvement or response to treatment

  six months

Study Arms (2)

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.

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

Other: cognitive stimulation; Device: sham transcranial direct current stimulation

Interventions

transcranial direct current stimulation DEVICE

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.

1. tDCS active

cognitive stimulation OTHER

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.

1. tDCS active; 2. sham tDCS

sham transcranial direct current stimulation DEVICE

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.

2. sham tDCS

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional Autonoma de Mexico: lead

Study Sites (1)

Universidad Nacional Autónoma de México

Mexico City, Coyoacan, 04510, Mexico

Location

Related Publications (4)

• 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.

  PMID: 33070785 BACKGROUND

• Chase 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.

  PMID: 31455860 BACKGROUND

• Jog 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.

  PMID: 31938757 BACKGROUND

• Jin 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.

  PMID: 38765850 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major; Cognitive Dysfunction

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Diana Patricia Guízar Sánchez, PhD

  Universidad Nacional Autonoma de Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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 moments of the stimulator being turned on, without being able to modify cortical excitability. 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full-time tenured career professor

Model Details: 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.

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 20, 2024
• Study Start: July 22, 2024
• Primary Completion: December 12, 2024
• Study Completion: August 26, 2025
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)