tDCS as Adjunctive Therapy to Cognitive Stimulation in Medical Students With Depression
NCT Number: NCT06562387
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Clinical Trial
Interventions: DEVICE: transcranial direct current stimulation|OTHER: cognitive stimulation|DEVICE: sham transcranial direct current stimulation
Sponsor: Universidad Nacional Autonoma de Mexico
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-22
Completion Date: 2025-08-26
Locations: Universidad Nacional Autónoma de México, Mexico City, Coyoacan, 04510, Mexico

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.

Primary Outcome Measures: 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 Outcome Measures: To compare Electrophysiological improvement on P300 between active and sham tDCS groups, increase P300 amplitude from the seventh stimulus onwards \*p\>0.05, three months
Other Outcome Measures: Global improvement or response to treatment, remain the same or have increased 1 point on the Clinical Global Impression Scale. The higher the score, the better the overall performance., six months