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

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

Interventions

DEVICE

transcranial direct current stimulation

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.

OTHER

cognitive stimulation

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.

DEVICE

sham transcranial direct current stimulation

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.

Sponsors & Collaborators

• Universidad Nacional Autonoma de Mexico

  lead OTHER

Principal Investigators

• Diana Patricia Guízar Sánchez, PhD · Universidad Nacional Autonoma de Mexico

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

30 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-07-22

Primary Completion

2024-12-12

Completion

2025-08-26

Countries

• Mexico

Study Locations