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Development of a new technology for the rapid treatment of insomnia disorder by cTBS and exploration of neural mechanisms

Development of a new technology for the rapid treatment of insomnia disorder by cTBS and exploration of neural mechanisms

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095757
Enrollment
Unknown
Registered
2025-01-13
Start date
2025-01-20
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Insomnia disorder

Interventions

sham a-cTBS group:sham a-cTBS treatment

Sponsors

Affiliated Kangning Hospital of Ningbo University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Age 18~60 years old; (2) diagnostic criteria for insomnia disorders in the International Classification of Diseases and Related Health Problems, Revision 11 (ICD-11); (3) The total score of PSQI is >5; (4) right-handed; (5) The patient's physical examination, medical history, vital signs, hematuria and stool routine, liver and kidney function, electrolytes, electrocardiogram, electroencephalogram and other indicators were normal; (6) After fully understanding the safety of transcranial magnetic stimulation (TMS), willing to actively cooperate with the treatment, and sign the informed consent by the person and his family.

Exclusion criteria

Exclusion criteria: (1) Patients with severe physical diseases, infectious diseases and immune system diseases; (2) Patients with severe neurological diseases, mental retardation or cerebral organic diseases; (3) The patient has metal or electronic devices built into the body, such as intracranial metal foreign bodies, cochlear implants, pacemakers, stents and other metal foreign bodies; (4) Have a risk of seizures, have previous craniocerebral disease, head trauma, alcoholism, electroencephalogram abnormalities, MRI evidence of brain structural abnormalities, or have a family history of epilepsy; (5) ECT treatment within 2 months prior to enrollment; (6) Those who have psychotic symptoms and need to be combined with antipsychotic drugs; (7) Those who are pregnant, breastfeeding, or planning to become pregnant during the trial.

Design outcomes

Primary

MeasureTime frame
The Hamilton Depression Scale (HAMD);The Hamilton Anxiety Scale (HAMA);The Pittsburgh Sleep Quality Index (PSQI);The Clinical General Impressions Scale (CGI) ;Sleep diary;

Secondary

MeasureTime frame
Electromyographic changes;EEG changes;Near infrared functional imaging;3.0T Nuclear Magnetic (MRI);

Countries

China

Contacts

Public ContactQi Zhou

Affiliated Kangning Hospital of Ningbo University

993688007@qq.com+86 574 26302520

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026