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Transcranial temporal interference stimulation for depression: A clinical randomized controlled trial

Transcranial temporal interference stimulation for depression: A clinical randomized controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118650
Enrollment
Unknown
Registered
2026-02-09
Start date
2026-02-09
Completion date
Unknown
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Interventions

Sponsors

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. be 18-60 years of age, male or female, right-handed. 2. meets the DSM-5 diagnosis of current or recurrent episodes of major depressive disorder. 3. structured diagnostic confirmation using the MINI; additional SCID-5 review if diagnostic uncertainty exists or if further exclusion of bipolar/psychotic disorders is required. 4. duration of the current depressive episode >=4 weeks. 5. 17-item Hamilton Depression Scale >=14 points. 6. presence of subjective cognitive symptoms at the time of PDQ-D scoring. 7. voluntary participation in the study and written informed consent.

Exclusion criteria

Exclusion criteria: 1. other significant mental disorder: bipolar disorder, schizophrenia or other psychotic disorder, autism spectrum disorder, severe neurocognitive disorder, intellectual disability; or current obsessive-compulsive disorder (OCD), PTSD, eating disorders, or anxiety disorders that significantly affect functioning. 2. recent history of strong interventions: ECT, ketamine/eketamine, rTMS/tDCS in the last 4 weeks. 3. suicidal risk: suicide attempt in the last 12 months; or current definite suicidal plan, clinically assessed as inappropriate for participation. 4. neurological disorders: epilepsy, stroke, loss of consciousness following craniocerebral trauma, intracranial tumour, demyelinating disease or other definite organic brain lesions. 5. severe or unstable somatic disease: uncontrolled cardiovascular disease, severe hepatic or renal insufficiency, uncontrolled endocrine disease, etc., which in the judgement of the investigator may increase the risk of the study. 6. tTIS/MRI contraindications: metal implants in vivo or other MRI contraindications; presence of severe skin lesions in the area of scalp irritation; severe claustrophobia. 7. Pregnant or lactating females. 8. Those taking cognitive-impairing medications (e.g., anticholinesterases, psychostimulants, and other anti-dementia medications) within 4 weeks prior to enrolment that cannot be discontinued upon assessment. 9. Previous history of alcohol or tobacco abuse. 10. Other conditions that, in the judgement of the investigator, make enrolment inappropriate. 11. Other diseases affecting cognitive function.

Design outcomes

Primary

MeasureTime frame
Depression Perceptual Deficits Questionnaire;

Secondary

MeasureTime frame
Hamilton Anxiety and Depression Scale;Selective reaction time identification task;Numeric Symbol Substitution Test;

Countries

China

Contacts

Public ContactZhu Zhou

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

zhouzhu@hust.edu.cn+86 27 8366 3372

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026