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Cerebellar repetitive transcranial magnetic stimulation in patients with chronic insomnia: a double-blind, randomised controlled study

A multimodal neurological function study in insomnia patients before and after TMS cerebellar stimulation treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105859
Enrollment
Unknown
Registered
2025-07-14
Start date
2025-07-20
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

insomnia

Interventions

real TMS group:Transcranial magnetic stimulation
Sham TMS Group:Sham stimulation

Sponsors

The Affiliated Brain Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-65 years old (both male and female). 2. Meet the ICSD-3 diagnostic criteria for insomnia. 3. Pittsburgh Sleepiness Quotient Inventory (PSQI) score = 7. 4. Hamilton Anxiety Scale (HAMA) < 14 points and Hamilton Depression Scale (HAMD) < 17 points. 5. Consent and co-operation in the use of transcranial magnetic stimulation therapy, polysomnography and magnetic resonance scanning. 6. Consent to the collection of clinical data and assessment of relevant scales. 7. Voluntary enrolment and signing of informed consent or consent to privacy agreement.

Exclusion criteria

Exclusion criteria: 1. Left-handedness. 2. Other types of sleep disorders, including periodic limb movement index >=15/h and AHI >=5/h. 3. Craniofacial malformations, with metallic implants in the body or on the body surface that cannot be removed. 4. Those with a previous history of organic cranio-cerebral diseases such as epilepsy, traumatic brain injury, stroke, intracranial infection, etc. 5. Those suffering from other serious mental diseases, suicidal tendency, drug and alcohol dependence. Patients with other serious medical diseases. 6. Patients with cognitive dysfunction according to the results of MMSE examination. 7. Women who are pregnant or breastfeeding. 8. Patients who are unable to adhere to the full treatment due to distance, work, or other reasons, or who are unable to return for follow-up visits in a timely manner.

Design outcomes

Primary

MeasureTime frame
Brain functional connectivity;Electroencephalogram parameters;PSQI score;—

Secondary

MeasureTime frame
ISI score;AIS score;ESS score;HAMD score;HAMA score;—

Countries

China

Contacts

Public ContactLi Zhang

The Affiliated Brain Hospital of Nanjing Medical University

neuro_zhangli@163.com+86 138 1393 8880

Outcome results

None listed

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