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A Randomized Controlled Trial of HI-tACS Combined with iTBS in the Treatment of Depression

Clinical Randomized Controlled and Brain Mechanism Study on Transcranial High-Intensity Alternating Current (HI-tACS) Combined with Intermittent Theta Burst Stimulation (iTBS) in the Treatment of Depression

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120005
Enrollment
Unknown
Registered
2026-03-06
Start date
2026-03-06
Completion date
Unknown
Last updated
2026-03-09

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

Conditions

Depressive disorder

Interventions

A Group (Real HI-tACS combined with Real iTBS treatment group):Real HI-tACS combined with Real iTBS treatment
B Group (Sham HI-tACS combined with Real iTBS treatment group):Sham HI-tACS combined with Real iTBS treatment
C Group (Real HI-tACS combined with Sham iTBS treatment group):Real HI-tACS combined with Sham iTBS treatment

Sponsors

Ningbo First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years old, right-handed; 2. Meets the diagnostic criteria for depression in the Diagnostic and Statistical Manual of Mental Disorders -5; HAMD-17 scores >= 17; 3. Agree to participate in this study and sign the informed consent form; 4. The subjects have been consistently taking the same type and dose of antidepressant medication for at least 15 days prior to enrollment;

Exclusion criteria

Exclusion criteria: 1. Serious physical illness; 2. Current or past organic brain or neurological disorders; 3. According to the Mini-International Neuropsychiatric Interview(M.I.N.I.)comorbidities with other mental illnesses are evaluated; 4. Previous or current history of receiving rTMS, transcranial electrical stimulation, electroconvulsive therapy, or other neuroregulatory treatments; 5. There are contraindications for transcranial magnetic stimulation therapy, such as personal or family history of epilepsy, cochlear implants, increased intracranial pressure, pacemaker implantation, or head metal implants; 6. Pregnancy or lactation; 7. Participate in concurrent clinical trials;

Design outcomes

Primary

MeasureTime frame
Efficacy rate after 2 weeks of treatment;Remission rate after 2 weeks of treatment;

Secondary

MeasureTime frame
Hamilton Depression Rating Scale-17;Hamilton Anxiety Rating Scale;Pittsburgh Sleep Quality Index;Schedule for Affective Disorders and Schizophrenia - Life Events Schedule;Brief Symptom Inventory;

Countries

China

Contacts

Public ContactJi Yunxin

Ningbo First Hospital

janegege123@163.com+86 574 87085233

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026