Clinical trial NCT06658795: Treating Loneliness In The Older Adult With Depression With tDCS
Official title: Effects of Transcranial Direct Current Stimulation on Loneliness in Older Adults With Depression: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Loneliness
Keywords: Randomization Controlled Trial
Transcranial Direct Current Stimulation
Depression
loneliness
Lead sponsor: Guangzhou Psychiatric Hospital
Sponsor class: OTHER_GOV
Collaborators: name: The University of Hong Kong
First posted: 2024-10-26
Enrollment: 180
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The tDCS parameters were set to a current of 2mA for a single session lasting 20 minutes. Based on the EEG 10-20 international system, the positive electrode for stimulating the rVLPFC was placed at position F6, while the negative electrode was placed in the left supraorbital area/FP1 (e.g., He et al., 2020, Psychol Med) (Figure 1-5a). For stimulating the lDLPFC, the positive electrode was placed at position F3, and the negative electrode was placed in the right supraorbital area/FP2 (e.g., Dubreuil-Vall et al., 2021, Biol Psychiatry: CNNI) (Figure 1-5b). In the sham stimulation group, the electrode positions were randomized to match those of the rVLPFC or lDLPFC groups, but the stimulation only lasted for the first 30 seconds.
Primary purpose: TREATMENT

Brief summary: High loneliness is prevalent among older adults and is a significant risk factor for major depression and low recovery rates in patients. Current interventions for loneliness are limited. Previous research has demonstrated a link between loneliness, negative social emotions, and reduced resting-state functional connectivity in the lateral prefrontal cortex (LPFC) and the default mode network (DMN). Transcranial direct current stimulation (tDCS) has shown promise in enhancing emotional regulation and connectivity, potentially alleviating loneliness in older adults with depression.

Detailed description: Loneliness is a pervasive issue among older adults, significantly increasing the risk of major depression and contributing to low recovery rates in affected individuals. Despite its widespread impact, current interventions aimed at alleviating loneliness remain limited and often ineffective. Research has revealed a strong connection between feelings of loneliness, negative social emotions, and decreased resting-state functional connectivity in key brain regions, particularly the lateral prefrontal cortex (LPFC) and the default mode network (DMN). These findings suggest that the neural underpinnings of loneliness may be targeted to improve emotional well-being.

Transcranial direct current stimulation (tDCS) emerges as a promising intervention in this context, as it has been shown to enhance emotional regulation and improve functional connectivity within these neural networks. By applying low electrical currents to specific brain areas, tDCS may help mitigate feelings of loneliness, thereby fostering a greater sense of social connection among older adults with depression.

Objectives Evaluate the Effects of Repeated tDCS on Loneliness Levels: This trial aims to systematically assess how repeated sessions of tDCS influence loneliness in older adults with major depressive disorder. By comparing these groups, we hope to understand the differential impacts of tDCS on loneliness, taking into account the potential confounding effects of depression.

Elucidate the Neuro-Emotional Mechanisms: A key objective is to uncover the neuro-emotional mechanisms that underlie the effects of tDCS on loneliness. This involves examining changes in neural activity and connectivity patterns in the LPFC and DMN, as well as tracking shifts in negative social emotions that may accompany improvements in loneliness. Understanding these mechanisms could enhance the efficacy of tDCS as an intervention.

Develop Predictive Models for Individualized Treatment Outcomes: Another important aim of this trial is to create predictive models that utilize neuro-emotional data to tailor treatment approaches for individuals. By identifying specific neural and emotional markers that correlate with positive outcomes from tDCS, we can move toward more personalized interventions, potentially improving recovery rates and overall mental health in older adults with depression facing loneliness.

This trial represents a significant step toward addressing the critical issue of loneliness in older adults with depression, with the potential to offer a novel and effective intervention strategy that integrates neurobiology and emotional health.

Eligibility criteria: Inclusion Criteria:

* High loneliness (UCLA Loneliness Scale \> 43).
* Diagnosis of major depressive disorder confirmed by the Structured Clinical Interview for DSM-5 Disorders.
* absence of suicidal ideation (Hamilton Depression Scale item 3 score ≤ 1).

Exclusion Criteria:

* Severe neurological diseases.
* Bipolar disorder, schizophrenia, addiction, or impulse control disorders.
* Contraindications for tDCS or MRI (e.g., metal implants).
* Presence of suicidal ideation.

Primary outcomes:
measure: Change in loneliness levels from baseline measured by the UCLA Loneliness Scale from baseline
timeFrame: 2 weeks, 1.5 months and 3.5 months
Secondary outcomes:
measure: Change in Emotional and Motivational Ratings from baseline
timeFrame: 2 weeks, 1.5 months and 3.5 months
measure: changes in Social Participation Levels from baseline
timeFrame: 2 weeks, 1.5 months and 3.5 months
measure: changes in Social Motivation from baseline
timeFrame: 2 weeks, 1.5 months and 3.5 months
measure: changes in Social Network from baseline
timeFrame: 2 weeks, 1.5 months and 3.5 months
measure: changes in Emotional Regulation from baseline
timeFrame: 2 weeks, 1.5 months and 3.5 months
measure: changes in Affective Traits from baseline
timeFrame: 2 weeks, 1.5 months and 3.5 months
measure: changes in Reward Sensitivity from baseline
timeFrame: 2 weeks, 1.5 months and 3.5 months
measure: changes in Depressive Symptoms from baseline
timeFrame: 2 weeks, 1.5 months and 3.5 months
measure: changes in Resting-State Functional Connectivity from baseline
timeFrame: 2 weeks, 1.5 months and 3.5 months
measure: Change in social support from baseline
timeFrame: 2 weeks, 1.5 months and 3.5 months
measure: changes in Emotion Coping from baseline
timeFrame: 2 weeks, 1.5 months and 3.5 months
measure: changes in Incentive-Driven Behavioural Tendencies from baseline
timeFrame: 2 weeks, 1.5 months and 3.5 months
measure: changes in Anhedonia level from baseline
timeFrame: 2 weeks, 1.5 months and 3.5 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Brain Hospital
state: Guangdong
Study officials:
References:
citation: Dubreuil-Vall L, Gomez-Bernal F, Villegas AC, Cirillo P, Surman C, Ruffini G, Widge AS, Camprodon JA. Transcranial Direct Current Stimulation to the Left Dorsolateral Prefrontal Cortex Improves Cognitive Control in Patients With Attention-Deficit/Hyperactivity Disorder: A Randomized Behavioral and Neurophysiological Study. Biol Psychiatry Cogn Neurosci Neuroimaging. 2021 Apr;6(4):439-448. doi: 10.1016/j.bpsc.2020.11.006. Epub 2020 Nov 25.
citation: He Z, Liu Z, Zhao J, Elliott R, Zhang D. Improving emotion regulation of social exclusion in depression-prone individuals: a tDCS study targeting right VLPFC. Psychol Med. 2020 Dec;50(16):2768-2779. doi: 10.1017/S0033291719002915. Epub 2019 Oct 16.