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Clinical study of low intensity transcranial focused ultrasound in the treatment of insomnia with anxiety and depression

Clinical study of low intensity transcranial focused ultrasound in the treatment of insomnia with anxiety and depression

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109354
Enrollment
Unknown
Registered
2025-09-17
Start date
2025-06-20
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

Insomnia with anxiety and depression

Interventions

Intervention group:Inhibitory transcranial ultrasound stimulation, 10 minutes/day, 7 days in total.
Control group:Transcranial ultrasound stimulation with intensity parameter of 0, 10 minutes/day, 7 days in total.

Sponsors

Xuanwu Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Right-handed patients aged between 18 and 65 years, regardless of gender; 2. Diagnosis of insomnia based on the diagnostic criteria for insomnia related to other psychiatric disorders in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV); 3. Meeting the DSM-IV structured clinical interview diagnostic criteria for generalized anxiety and depression; 4. Duration of insomnia >= 3 months; 5. PSQI score >= 7; 6. HAMA score >= 14; 7. HAMD-17 score >= 8; 8. If the patient is currently taking medication, they agree to maintain their current medication regimen throughout the entire trial; 9. Willingness to participate in the study and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Have serious or unstable organic diseases, such as heart, liver, or kidney diseases; 2. Have a history of epilepsy, hydrocephalus, or other central nervous system diseases; 3. Suffer from mental disorders other than anxiety and mild to moderate depression (e.g., schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, obsessive-compulsive and related disorders, etc.); 4. Insomnia caused by specific conditions such as anemia, hyperthyroidism, severe sleep apnea, restless legs syndrome, or shift work; 5. Pregnant or lactating women; 6. Presence of metal implants in the body, such as pacemakers, deep brain stimulation electrodes, cardiac stents, or other therapeutic devices; 7. Participated in any other clinical trial within one month prior to baseline.

Design outcomes

Primary

MeasureTime frame
Assessment of the severity of insomnia;

Secondary

MeasureTime frame
Clinical symptoms;Electrophysiology;Functional magnetic resonance imaging;

Countries

China

Contacts

Public ContactLiu Chunyan

Xuanwu Hospital Capital Medical University

lcysfysg@xwhosp.org+86 153 1318 5676

Outcome results

None listed

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