Neural Mechanisms of Temporal Interference Stimulation on Improving Social Reward Function in Depression

ConditionDepression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-65
SponsorShanghai Mental Health Center

About this trial

Major depressive disorder (MDD) is a mood disorder characterized primarily by low mood, diminished interest, and reduced energy. Traditional views considered depression a non-degenerative condition; however, recent epidemiological studies have revealed its significant association with impaired social functioning. Data indicate that 59.3% of patients with depression experience social dysfunction of varying severity \[1\], particularly manifesting as difficulties in social interaction and relationship maintenance \[2\]. Therefore, investigating the mechanisms underlying social dysfunction is of great importance for promoting functional recovery in MDD, and dysfunction within the social reward system may represent a core factor, though the specific neural mechanisms remain unclear.

The ultimate goal of understanding the neural mechanisms underlying social reward impairment in depressed patients is to improve therapeutic outcomes. Temporal Interference (TI) stimulation, as a non-invasive deep brain stimulation technique, utilizes high-frequency current differentials to generate low-frequency amplitude-modulated electric fields, enabling precise targeting of deep brain regions. This study employs multimodal assessment methods-such as functional magnetic resonance imaging (fMRI), electroencephalography (EEG), and specific cognitive-behavioral tasks-combined with TI stimulation to observe immediate changes in functional connectivity, neural activity, and related cognitive functions (e.g., decision-making, memory) across participant groups. The research aims to elucidate the roles of the parahippocampal gyrus, orbitofrontal cortex, and striatum in social reward impairment in depression, and to explore circuit-based intervention targets, thereby providing novel strategies for the recovery of social functioning in MDD.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

16-60 years old;

Meeting with the criteria of major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5;

Scored 20 or higher on the Hamilton's Depression Scale with 24 items (HAMD-24);

With enough audio-visual ability and comprehensive ability to accomplish the visits;

Disqualifiers

Severe medical or neurological problems;

Previous mania or hypomania episodes;

Female patients who are pregnant, planning to be pregnant or breastfeeding;

Actively suicide ascertained by research psychiatrist or 3rd item of HAMD scored≥3(suicidality);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Temporal Interference Simulation(TIS)

    Device

    the total stimulation duration was 20 minutes, including a 40-second current ramp-up at the beginning and a 40-second ramp-down at the end.

  • Temporal Interference Stimulation(TIS)

    Device

    Sham stimulation has only 40 seconds of current ramping-up and ramping-down at the beginning and end of the stimulation to simulate the sensation of actual stimulation.

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: orbitofrontal cortexExperimental treatment 1 intervention
Group B: parahippocampal gyrusExperimental treatment 1 intervention
Group C: striatumExperimental treatment 1 intervention
Group D: shamSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Hamilton Depression Rating Scale (HAMD) Score

The HAMD is a clinical depression assessment and consists of 17 items with a total score range from 0 to 54.A higher score indicates a worse outcome.

Time frame
baseline and immediately after the intervention
2

Change in The Positive and Negative Affect Schedule (PANAS) Score

The Positive and Negative Affect Schedule (PANAS) is an assessment of participants' immediate affective states and consists of 20 items divided into two subscales (10 items for Positive Affect and 10 items for Negative Affect), with each item rated on a 5-point scale; higher scores on the Positive Affect subscale indicate more positive emotional states, while higher scores on the Negative Affect subscale indicate more negative emotional states.

Time frame
Baseline and immediately after the intervention

Secondary outcomes

1

MRI measures

The functional connectivity between stimulated target and the whole brain areas

Time frame
Baseline and immediately after the intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.