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A single-blind clinical randomized controlled study of low-intensity transcranial focused ultrasound to improve depressive symptoms

Effect of Low-Intensity Transcranial Focused Ultrasound Stimulation in Patients with depression: A Randomized,single-Blind, Sham-Controlled Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087618
Enrollment
Unknown
Registered
2024-07-31
Start date
2024-02-25
Completion date
Unknown
Last updated
2024-08-05

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

Conditions

Depression

Interventions

Treatment Group:With excitatory true stimulation parameters, the patients left dorsolateral prefrontal cortex (dlPFC) was stimulated with low-intensity transcranial focused ultrasound stimulation (tFU
Control Group:With sham stimulation parameters, the patients left dorsolateral prefrontal cortex (dlPFC) was stimulated with low-intensity transcranial focused ultrasound stimulation (tFUS) 30minutes

Sponsors

Samii Medical Center,Shenzhen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1)Aged between 18-65 years old; (2)Diagnosed with mild or moderate depression; (3)No history of epilepsy, serious neurological disease or other psychiatric history; (4)No exposure to other neuromodulation therapy within the last 30 days; (5)Appropriate for magnetic resonance examination (no metal implants in the body); (6) During the study period, treatments (including medications) other than receiving ultrasound stimulation must remain consistent with the regimen prior to participation in the study, i.e., remain on a stable antidepressant medication regimen, or remain medication-free, throughout the study (including all follow-up evaluations after the treatment regimen); (7)The patient or guardian has given consent for the treatment to proceed.

Exclusion criteria

Exclusion criteria: (1) Severe systemic disease with possible life and health risks during the study; (2) Comorbidity with other severe neuropsychiatric illnesses or developmental delay that prevents cooperation; (3) Contraindication to magnetic resonance examination (metal implants in the body); (4) Pregnant/nursing women; (5)Substance abuse or alcoholism; (6) Suicidal ideation.

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Scale -24 items, HAMD-24;brain functional connectivity;—

Secondary

MeasureTime frame
Hamilton Anxiety Scale -14 items, HAMA-14;Pittsburgh Sleep Quality Index, PSQI;electroencephalogram, EEG;—

Countries

China

Contacts

Public ContactBo Yuan

Shenzhen Samii Medical Center

yuanbo@ssmc-sz.com+86 138 2525 8808

Outcome results

None listed

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