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The effect and neural mechanism of low intensity focused ultrasound (LIFUP) on prolonged disorders of consciousness

Evaluation of the efficacy and safety of low-intensity focused ultrasound (LIFUP) in the treatment of chronic disorders of consciousness and study of the neural mechanism - The effect and neural mechanism of low intensity focused ultrasound (LIFUP) on prolonged disorders of consciousness

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092904
Enrollment
Unknown
Registered
2024-11-26
Start date
2024-11-30
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

disorders of consciousness

Interventions

A:Parameter a: In each stimulus module, LIFUP performs stimulation under the following parameters: Pulse repetition rate (PRF) is 100 Hz, Pulse Duration (PD) is 0.5 ms, base frequency is 500kHZ, mecha
B:Parameter b: PRF is 5Hz, PD is 20ms, fundamental frequency(FF) is 500kHZ, PRP is 200ms, ISI is 200ms, pulse train repeat (PTR) is 400 times of pulse repetition. Total stimulation time is 80s. The t
GroupC:For the spurious stimulus group, use parameter a to set the parameters, but the transducer power is off.

Sponsors

Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center) ; Hangzhou Normal University.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1)>28 days since injury or onset; 2)Age above 18y ; 3)Behavioral profile consistent with a VS/UWS or MCS, as assessed with the Coma Recovery Scale Revised; 4)Patients with no obvious disease fluctuation within a week.

Exclusion criteria

Exclusion criteria: 1)Without obvious heart diseases; 2)History of neurological illness prior to injury; 3) Inability to safely enter the MR environment; 4)Patients with skull defect in the left head; 5)Patients with intracranial metal implants.

Design outcomes

Primary

MeasureTime frame
Coma Recovery Scale,CRS-R;

Secondary

MeasureTime frame
Resting-state EEG;Functional magnetic resonance BOLD;PET-CT glucose metabolism signals;

Countries

China

Contacts

Public Contactdihaibo;liuhongxiang

Hangzhou Normal University; Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center)

dihaibo19@aliyun.com+86 135 8885 9929

Outcome results

None listed

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