Treating Loneliness In The Older Adult With Depression With tDCS

NCT ID: NCT06658795

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-29
• Study Completion Date: 2026-12-30

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.

Conditions

Major Depressive Disorder; Loneliness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Left DLPFC stimulation group

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 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)

Group Type: EXPERIMENTAL

Transcranial direct current stimulation (tDCS) on the Left DLPFC

Intervention Type: DEVICE

The tDCS parameters were set to a current of 2mA for a single session lasting 20 minutes. 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).

Right VLPFC stimulation group

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 right VLPFC 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).

Group Type: EXPERIMENTAL

Transcranial direct current stimulation (tDCS) on the right VLPFC

Intervention Type: DEVICE

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)

Sham stimulation group

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.

Group Type: SHAM_COMPARATOR

Sham stimulation group

Intervention Type: DEVICE

The electrode positions were randomized to match those of the rVLPFC or lDLPFC groups, but the stimulation only lasted for the first 30 seconds.

Interventions

Transcranial direct current stimulation (tDCS) on the Left DLPFC

The tDCS parameters were set to a current of 2mA for a single session lasting 20 minutes. 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).

Intervention Type: DEVICE

Transcranial direct current stimulation (tDCS) on the right VLPFC

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)

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: collaborator

Guangzhou Psychiatric Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Kangguang Lin

Director of the Department of Affective disorders

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Guangzhou Brain Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Kangguang Lin, PhD; MD

Role: CONTACT

klin@gzhmu.edu.cn

8613560360144

Robin Shao, PhD

Role: CONTACT

James0828@hotmail.com

Facility Contacts

Kangguang Lin, Ph.D; MD

Role: primary

linkangguang@163.com

8602081268219

References

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.

Reference Type: BACKGROUND

PMID: 33549516 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31615594 (View on PubMed)

Other Identifiers

2024-17

Identifier Type: -

Identifier Source: org_study_id