Efficacy and Mechanism of Transcranial Temporal Interference Stimulation (tTIS) in the Treatment of Adolescent Depression

Launched by XIJING HOSPITAL · Mar 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Transcranial Temporal Interference Stimulation (tTIS) for adolescents aged 13 to 17 who are experiencing major depression. The goal is to see how effective tTIS is in improving symptoms of depression and to understand how it works in the brain. The study will involve 30 participants, who will be divided into two groups: one group will receive the actual treatment while the other will receive a sham (placebo) treatment that does not have therapeutic effects. Throughout the trial, participants will undergo brain scans and assessments to track changes in their mood, anxiety, and cognitive function.

To be eligible for this trial, participants must be between 13 and 17 years old and meet specific criteria for major depression, which includes having a certain level of depressive symptoms. They should not have serious medical conditions, active suicidal thoughts, or recent changes in their treatment for depression. Participants can expect to attend 10 treatment sessions and have follow-up assessments at different points during the study to measure their progress. This research is important as it could lead to new, effective treatments for adolescents struggling with depression.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1) Age 13 - 17 years old; 2)Meet the DSM-5 criteria for MDD with a current MDE without psychotic features, as confirmed by the MINI 3) HAMD-17 total score of ≥20 4) No change in treatment regimen in the 4 weeks prior to screening 5) No severe mental disorders or intellectual disabilities; 6)Can cooperate actively with the experimental process and subsequent follow-up.
• Exclusion Criteria:
• • 1) serious diseases such as heart, liver, kidney and hematopoietic system disorders; 2) abuse drugs or are addicted to alcohol or suffer from uncontrollable mental illnesses; 3) Active suicidal intent, confirmed by the MINI Module B (Suicidality) or HAMD-17 item #3 score ≥3; 4) Pregnant or lactating; 5) Those who have identified definite organic lesions such as infarction foci, softening foci, hemorrhage foci, and space-occupying lesions through plain scan of cranial MRI; 6) Those with implanted objects in the brain (such as aneurysm clips, shunt devices, stimulators, cochlear implants or electrodes) or any other metal objects in or near the head, and cannot be safely removed; 7) Change in medication or psychotherapy treatment regimen before screening 8) Could not cooperate with fMRI examination or tTIS treatment; 9)Have received other forms of brain stimulation treatment in the past 3 months.