Depression
Conditions
Keywords
depression, transcranial direct current stimulation, dorsolateral prefrontal cortex, dorsomedial prefrontal cortex
Brief summary
Background: Depression is a common mental disorder characterized by persistent low mood and anhedonia. Pharmacological and psychotherapeutic treatments demonstrate only moderate efficacy. Non-invasive brain stimulation techniques offer novel therapeutic approaches. Among these, transcranial direct current stimulation (tDCS) holds advantages due to its simplicity, low cost, and minimal side effects, exhibiting good efficacy and tolerability in depression treatment. The dorsolateral prefrontal cortex (DLPFC), a core region of the cognitive control network, serves as a traditional target for non-invasive brain stimulation in depression and plays a crucial role in positive affect (PA) processing. Conversely, the dorsomedial prefrontal cortex (DMPFC), a central region of the default mode network, participates in negative self-referential processing and negative affect (NA) regulation, demonstrating potential as a novel therapeutic target. Objective: Given the distinct roles of DLPFC and DMPFC in separate affective regulation networks, this study aims to investigate the differential effects of different tDCS targets on emotional regulation in patients with depression. Design: This study employed a randomized, double-blind, controlled design. Participants diagnosed with depression will be randomly assigned to receive either effective tDCS targeting the left DLPFC or effective tDCS targeting the DMPFC. Primary outcome measures focus on changes in clinical symptom assessments.
Detailed description
Background: Depression is a common mental disorder characterized by persistent low mood and anhedonia. Pharmacological and psychotherapeutic treatments demonstrate only moderate efficacy. Non-invasive brain stimulation techniques offer novel therapeutic approaches. Among these, transcranial direct current stimulation (tDCS) holds advantages due to its simplicity, low cost, and minimal side effects, exhibiting good efficacy and tolerability in depression treatment. The dorsolateral prefrontal cortex (DLPFC), a core region of the cognitive control network, serves as a traditional target for non-invasive brain stimulation in depression and plays a crucial role in positive affect (PA) processing. Conversely, the dorsomedial prefrontal cortex (DMPFC), a central region of the default mode network, participates in negative self-referential processing and negative affect (NA) regulation, demonstrating potential as a novel therapeutic target. Objective: Given the distinct roles of DLPFC and DMPFC in different affective regulation networks, this study aims to investigate the differential effects of tDCS targeting these regions on emotional regulation in patients with depression. Design: This study employed a randomized, double-blind, controlled design. Inpatients with depression were recruited from the Department of Psychology and Sleep Medicine at the Second Affiliated Hospital of Anhui Medical University. Participants were randomly assigned to receive either effective tDCS targeting the left DLPFC or effective tDCS targeting the DMPFC. Both groups will receive tDCS treatment twice daily for 5 consecutive days. Each session lasts 20 minutes at 2mA, with a minimum 4-hour interval between sessions. Before the start of tDCS treatment and after completion of all sessions, clinical psychologists conducted standardized assessments and collected EEG data from the patients. Assessments included tests of associative memory, the Self-Rating Depression Scale (SDS), the 17-item Hamilton Depression Rating Scale (HAMD), Hamilton Anxiety Rating Scale (HAMA), 15-item Somatic Symptom Severity Scale of the Patient Health Questionnaire (PHQ-15), PHQ-15), the Insomnia Severity Index (ISI), the Positive and Negative Affect Scale (PANAS), and the Ruminative Responses Scale (RRS). Follow-up was conducted after one month, during which only the HAMD scale was assessed. Primary clinical outcomes included changes in HAMD scores at baseline, post-treatment, and 1-month follow-up; number of responders and remitters post-treatment (response defined as \>50% reduction in HAMD score at endpoint; remission defined as HAMD score ≤7 at endpoint); improvement in PANAS scores post-treatment; correlation between HAMD improvement and PANAS improvement. Secondary outcomes included changes in residual scale scores post-treatment, changes in EEG signals in stimulated brain regions, and changes in functional connectivity across the entire brain.
Interventions
DEVICEtranscranial direct current stimulation (tDCS)
Stimulation was delivered using a high-precision transcranial direct current stimulation (tDCS) device (Soterix Medical, Inc., New York, USA) via five small electrode pads (1 cm × 1 cm) arranged in a 4×1 ring configuration.
Sponsors
The Second Hospital of Anhui Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Stimulation was delivered using a high-precision transcranial direct current stimulation (tDCS) device (Soterix Medical, Inc., New York, USA) via five small electrode pads (1 cm × 1 cm) arranged in a 4×1 ring configuration. Following the international 10/20 EEG system: For the dorsolateral prefrontal cortex (DLPFC) group, the anode centered at F3 received 100% of the 2 mA current, while the cathode received 25% of the current via four peripheral electrodes at Fp1, F7, C3, and Fz. For the dorsomedial prefrontal cortex (DMPFC) group, the anode centered at Fz received 100% of the 2 mA current, while the cathode centered at Fz received 25% of the current via four peripheral electrodes at Fpz, F3, Cz, and F4. Participating patients with depression were randomly assigned to receive either active tDCS targeting the left DLPFC or active tDCS targeting the DMPFC. Both groups received tDCS treatment twice daily for 5 days, with each session lasting 20 minutes at 2 mA.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* The diagnosis meets the criteria for depression outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). * Age between 18 and 65 years. * Education level exceeding 5 years, with no significant hearing or visual impairments. * Voluntary signing of informed consent and ability to cooperate with general demographic data collection and neuropsychological scale testing.
Exclusion criteria
* Age under 18 or over 65. * Patients with neurological disorders such as epilepsy or severe physical illnesses. * Patients with comorbid neuropsychiatric disorders, such as schizophrenia or obsessive-compulsive disorder. * Patients unable to undergo tDCS treatment for any reason, including presence of ferromagnetic metal in the head or implanted medical devices in the head/neck region. * Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 17-item Hamilton Depression Rating Scale (HAMD) | Baseline, immediately after all intervention, and follow-up after all intervention (1 month). | Improvement in HAMD scores following transcranial direct current stimulation (tDCS) treatment (The HAMD consists of 17 items, with a total score ranging from 0 to 53; a higher score indicates more severe depressive symptoms). |
| Positive and Negative Affect Schedule (PANAS) | Baseline and immediately after all intervention. | The degree of improvement in PANAS scores following transcranial direct current stimulation (used to assess patients' positive and negative emotions; consisting of 20 items, with 10 items representing positive emotions; the total positive emotion score ranges from 0 to 50, with higher scores indicating greater vitality and enthusiasm; the other 10 items represent negative emotions, with the total negative emotion score ranging from 0 to 50; higher scores indicate stronger negative emotions). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Rating Depression Scale (SDS) | Baseline and immediately after all intervention. | Improvement in SDS (SDS comprises 20 items with a total score range of 0-100; higher scores indicate more severe depressive symptoms) scores following transcranial direct current stimulation treatment. |
| Hamilton Anxiety Rating Scale (HAMA) | Baseline and immediately after all intervention. | Improvement in HAMA (HAMA comprises 14 items with a total score range of 0-56; higher scores indicate more severe anxiety symptoms) scores following transcranial direct current stimulation treatment. |
| 15-item Somatic Symptom Severity Scale of the Patient Health Questionnaire (PHQ-15) | Baseline and immediately after all intervention. | Improvement in PHQ-15(comprising 15 items with a total score of 30; higher scores indicate more severe somatization symptoms) scores following transcranial direct current stimulation treatment. |
| Insomnia Severity Index (ISI) | Baseline and immediately after all intervention. | Improvement in ISI(comprising 7 items with a total score of 28; higher scores indicate more severe insomnia) scores following transcranial direct current stimulation treatment. |
| Ruminative Responses Scale (RRS) | Baseline and immediately after all intervention. | Improvement in RRS (comprising 22 items with a total score of 88; higher scores indicate more severe rumination tendencies) scores following transcranial direct current stimulation treatment. |
| EEG measurements | Baseline and immediately after all intervention. | Changes in EEG signal metrics in the stimulated target brain regions and in functional connectivity with the entire brain. |
Countries
China
Contacts
CONTACTYanghua Tian
Outcome results
None listed