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A multicenter, randomized, double-blind controlled study on the treatment of refractory depression by accelerating intermittent theta burst stimulation (a-iTBS) targeting the left primary motor cortex (M1)

A multicenter, randomized, double-blind controlled study on the treatment of refractory depression by accelerating intermittent theta burst stimulation (a-iTBS) targeting the left primary motor cortex (M1)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119535
Enrollment
Unknown
Registered
2026-02-28
Start date
2026-03-07
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Depressive

Interventions

The sham aiTBS group:Sham stimulation group
The active aiTBS group:Active stimulation group

Sponsors

Affiliated Kangning Hospital of Ningbo University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18 - 65 years old, gender not restricted; 2. Meets the diagnostic criteria for depression as outlined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). 3. The total score of HAMD-24 is >= 20 points; 4. Take a stable dose of antidepressant medication for at least 2 weeks; 5. The patient's physical examination, medical history, vital signs, routine tests of blood, urine and stool, liver and kidney functions, electrolytes, electrocardiogram, and electroencephalogram were all within normal ranges. 6. After fully understanding the safety of TMS, willing to actively cooperate with treatment and obtain informed consent from the patient and their family members.

Exclusion criteria

Exclusion criteria: 1. Has a history of severe physical illness and depression caused by psychoactive substances and non-substance-dependent substances; 2. Patients who have metal or electronic devices implanted in their bodies, such as intracranial metal foreign bodies, cochlear implants, cardiac pacemakers, and metal stents, etc. 3. There is a risk of epilepsy seizure. The patient has a history of brain diseases, head trauma, alcohol abuse, abnormal electroencephalogram, MRI evidence of brain structure abnormalities, or a family history of epilepsy. 4. Those with psychotic symptoms who require combined use of antipsychotic drugs; 5. Those who have received ECT, TMS or tES treatment within 3 months prior to enrollment, as well as those who have undergone systematic psychological therapy; 6. Disorders of the movement system, including Parkinson's disease, spinal cord injury, spasticity, Huntington's disease, muscular dystrophy and osteoarthritis, etc.

Design outcomes

Primary

MeasureTime frame
Improvement of depressive symptoms;

Secondary

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

Countries

China

Contacts

Public ContactDongsheng Zhou

Affiliated Kangning Hospital of Ningbo University

wyzhouds@sina.com+86 574 2630 2565

Outcome results

None listed

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