The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Location status: Recruiting
NCT Number: NCT07500064
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Hefei, Anhui, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
The Second Hospital of Anhui Medical University
Other
A Comparative Study of the Clinical Efficacy of Transcranial Direct Current Stimulation Targeting the DLPFC Versus DMPFC in the Treatment of Depression
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07413874
Addison Disease, Adrenal Gland Diseases
Boone, North Carolina, United States
View Trial DetailsNCT02543983
Behavior, Behavioral Symptoms
Bethesda, Maryland, United States
View Trial DetailsNCT00024635
Anxiety Disorders, Behavior
Bethesda, Maryland, United States
View Trial DetailsNCT07692269
Anxiety, Anxiety Disorders
Beijing, Beijing Municipality, China
View Trial Details