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NCT07612501Not yet recruiting

Efficacy and Safety of Transcranial Temporal Interference Stimulation for Depression

Source: ClinicalTrials.gov · Last updated 28 May 2026

Brief summary (registry, in English)

The goal of this clinical trial is to learn whether transcranial temporal interference stimulation (tTIS) can help treat major depressive disorder (MDD) in adults. The study will also learn about the safety of tTIS and explore how it may affect brain structure and brain function. The main questions it aims to answer are whether active tTIS lowers depression symptom scores more than sham stimulation after treatment, and what medical problems or side effects participants have during or after tTIS. Researchers will compare active tTIS targeting the left anterior limb of the internal capsule, active tTIS targeting the left subgenual anterior cingulate cortex, and sham stimulation. Sham stimulation is designed to feel similar to real stimulation but does not provide the same active treatment. Participants with MDD will be randomly assigned to one of the three groups. They will receive two 20-minute treatment sessions each day for 5 days. They will complete depression, anxiety, pleasure, psychosomatic symptom, and safety assessments before treatment, after treatment, and during follow-up. They will also have brain magnetic resonance imaging scans before and after treatment.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
20 May 2026
Start date
30 May 2026
Primary completion date
30 May 2027
Lead sponsor
Yonggui Yuan
Diseases
Depression
NCT number
NCT07612501

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 30 May 2026 to the primary completion date, 30 May 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Receipt of transcranial magnetic stimulation, transcranial electrical stimulation, or electroconvulsive therapy within the past 3 months
  • Presence of metal implants or other contraindications to transcranial electrical stimulation or magnetic resonance imaging

Other illness

  • History of epilepsy, brain tumor, or brain trauma
  • Any other condition judged by the investigators to make participation unsuitable for this study

Other

  • Acute or severe suicidal ideation

Who the study is looking for

  • Diagnosed with major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), by two independent psychiatrists
  • 24-item Hamilton Depression Rating Scale (HAMD-24) total score greater than 20 at baseline
  • Aged 18 to 65 years
  • Right-handed
  • Able to understand the study procedures and willing to provide written informed consent

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Zhongda Hospital Southeast University
Coordinator of this site? Confirm its status
NanjingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.