Temporal interference stimulation to improve social reward function in depression

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

This trial will try temporal interference stimulation, a noninvasive brain stimulation, to see if it improves social reward processing and social motivation in people aged 16–60 with major depressive disorder.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 16 Years to 65 Years
• Sex: All
• Sponsor: Shanghai Mental Health Center (Academic / other)
• Locations: 1 site (Shanghai, China)
• Trial ID: NCT07287878 on ClinicalTrials.gov

What this trial studies

Participants aged 16–60 who meet DSM-5 criteria for major depressive disorder and have moderate-to-severe symptoms will receive temporal interference stimulation (TIS) at Shanghai Mental Health Center. The intervention uses noninvasive, patterned electromagnetic fields intended to modulate deep brain networks involved in social reward, with clinical and neural/behavioral outcomes measured before and after treatment. Key inclusion criteria include HAMD-24 ≥20, HAMA and HCL-32 <14, and at least two atypical depressive symptoms; exclusions include prior mania/hypomania, severe medical or neurological conditions, pregnancy, or active suicidality. The protocol aims to link changes in neural activity produced by TIS to measurable improvements in social functioning.

Who should consider this trial

Good fit: Ideal candidates are people aged 16–60 with DSM-5 major depressive disorder, HAMD-24 score ≥20, HAMA and HCL-32 scores <14, at least two atypical symptoms, adequate audiovisual/cognitive ability, and suitability for antidepressant treatment.

Not a fit: Patients with severe medical or neurological illness, prior manic or hypomanic episodes, active suicidality, those who are pregnant or breastfeeding, or individuals who do not meet the symptom or age criteria are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, TIS could help restore social motivation and reward processing in depression, improving relationships and daily functioning.

How similar studies have performed: Other neuromodulation methods like transcranial magnetic stimulation and transcranial direct current stimulation have shown some benefits for mood and social functioning, but temporal interference stimulation is newer and has limited clinical evidence in humans, so it remains exploratory.

Eligibility criteria

Inclusion Criteria:

* 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;
* Be necessary and suitable to accept the treatment of antidepressants;
* Scored less than 14 on Hamilton's Anxiety Scale (HAMA) and scored less than 14 on the Hypomania Symptom Checklist-32 (HCL-32);
* With 2 or more atypical symptoms including significant weight gain or increase in appetite, hypersomnia, leaden paralysis, and a long-standing pattern of interpersonal rejection sensitivity that results in significant social or occupational impairment.

Exclusion Criteria:

* 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);
* Had ECT, MECT or rTMS in the past 6 months;
* Experienced severe personality disorder, mental retardation, anorexia/ bulimia nervosa.

Where this trial is running

Shanghai, China

• Shanghai Mental Health Center — Shanghai, China, China (Recruiting)

Study contacts

• Study coordinator: daihui Peng, MD. PhD.

Conditions Depression