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A Multicenter, Randomized, Double-Blind, Controlled Trial of Accelerated Intermittent Theta-Burst Stimulation (a-iTBS) Targeting the Left Primary Motor Cortex (M1) for Treatment-Resistant Depression

A Multicenter, Randomized, Double-Blind, Controlled Trial of Accelerated Intermittent Theta-Burst Stimulation (a-iTBS) Targeting the Left Primary Motor Cortex (M1) for Treatment-Resistant Depression

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127836
Enrollment
Unknown
Registered
2026-07-08
Start date
2026-07-15
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

Treatment-resistant depression

Interventions

Sham a-iTBS stimulation group:Sham stimulation
Active a-iTBS stimulation group:Active stimulation

Sponsors

Affiliated Kangning Hospital of Ningbo University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Age 18–55, any gender; 2. According to the MINI (International Neuropsychiatric Interview), meet the DSM-V criteria for TRD; 3. HAMD-24 total score >= 20; 4. Have taken at least two different types of antidepressants for 4 weeks each without effect; 5. Fully understand the safety of Ti, willing to actively cooperate with treatment, and consent signed by both the patient and family.

Exclusion criteria

Exclusion criteria: 1. A history of serious physical illnesses or depression caused by other psychoactive or non-dependent substances; 2. Presence of movement system diseases, including Parkinson’s disease, spinal cord injury, spasms, Huntington’s disease, muscular dystrophy, or osteoarthritis; 3. Risk of epilepsy, history of brain disease, head trauma, alcohol abuse, abnormal EEG, evidence of structural brain abnormalities on MRI, or a family history of epilepsy; 4. Presence of psychotic symptoms requiring treatment with antipsychotic medications; 5. Receiving ECT, TMS, or tES treatments, or systemic psychotherapy within the 3 months before enrollment; 6. Abnormalities in physical exam, medical history, vital signs, routine blood/urine/stool tests, liver and kidney function, electrolytes, ECG, EEG, or other indicators; 7. Presence of metal or electronic devices in the body, such as intracranial metal fragments, cochlear implants, pacemakers, or stents.

Design outcomes

Primary

MeasureTime frame
Assessment of Depressive Symptoms;

Secondary

MeasureTime frame
Electrophysiological indicators including brain region activation, functional connectivity, cortical plasticity, etc.;motor assessment;Other Core Symptoms of Depression;

Countries

China

Contacts

Public ContactDongsheng Zhou

Affiliated Kangning Hospital of Ningbo University

wyzhouds@sina.com+86 574 2630 2001

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026