Temporal interference stimulation for depressive disorder

Intervention Effect of Temporal Interference Stimulation (TIS) on Depressive Disorder

This test tries to see if temporal interference stimulation (TIS) can improve associative memory in adults with depressive disorder.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 12 Years to 60 Years
• Sex: All
• Sponsor: The Second Hospital of Anhui Medical University (other)
• Locations: 2 sites (Hefei, Anhui and 1 other locations)
• Trial ID: NCT07191392 on ClinicalTrials.gov

What this trial studies

Thirty adults with DSM‑5 diagnosed depressive disorder will receive either a 30‑minute session of temporal interference stimulation (TIS) or a sham TIS, with thirty matched healthy controls included for comparison. Participants complete neuropsychological assessments (including HAMD, HAMA, PHQ‑15, BSSI, PSQI, RRS, and others) and multimodal MRI (3D‑T1, resting‑state fMRI, and DTI) before and after the intervention. An incidental memory task using emotional pictures is used to measure associative memory changes pre‑ and post‑treatment. Clinical and imaging measures are compared between active and sham stimulation groups and against healthy controls.

Who should consider this trial

Good fit: Adults aged 18–65 with DSM‑5 depressive disorder (HAMD>17, BSS>6, PHQ‑15>5), right‑handed, with at least five years of education and normal or corrected vision who can attend study visits are ideal candidates.

Not a fit: People with severe heart, liver, or renal disease, major neurological disorders (e.g., stroke, epilepsy), comorbid psychotic or substance‑use disorders, pregnant or breastfeeding women, or those outside the 18–65 age range are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, TIS could improve associative memory and related depressive symptoms and provide a noninvasive treatment option.

How similar studies have performed: TIS is a novel neuromodulation method with limited human efficacy data, although related noninvasive techniques like TMS and tDCS have shown modest benefits for depression and cognition.

Eligibility criteria

Inclusion Criteria:

* the patients were diagnosed by more than 2 psychiatrists and met the diagnostic criteria of DSM-5 for depression, and HAMD\>17, BSS\>6, PHQ-15\>5.
* the age ranged from 18 to 65 years old, and the length of education was more than 5 years.
* the visual acuity or corrected visual acuity is normal, right-handed, can cooperate with the completion of various experimental tests.

Exclusion Criteria:

* accompanied by severe somatic diseases, such as severe heart, liver, renal insufficiency and so on.
* accompanied by other neurological diseases, such as stroke, epilepsy and so on. pregnant and lactating women.
* accompanied by other mental disorders, such as drug abuse, schizophrenia, schizophrenic affective

Where this trial is running

Hefei, Anhui and 1 other locations

• Anhui Medical University — Hefei, Anhui, China (RECRUITING)
• Anhui Mental Health Center — Hefei, Anhui, China (RECRUITING)

Study contacts

• Study coordinator: Yanghua Tian, PhD

Conditions: Depressive Disorder, Temporal Interference Stimulation