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Key technologies and systems for the assessment and early warning of elderly consciousness/cognitive impairment and multi-physical factor co-stimulation intervention-Transcranial Focused Ultrasound Stimulation for the Treatment of Disorders of Consciousness: A randomized Control Trial

Key technologies and systems for the assessment and early warning of elderly consciousness/cognitive impairment and multi-physical factor co-stimulation intervention-Transcranial Focused Ultrasound Stimulation for the Treatment of Disorders of Consciousness: A randomized Control Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103402
Enrollment
Unknown
Registered
2025-05-28
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-06-02

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

Conditions

disorder of consciousness

Interventions

DoC patient group A:tFUS for thalamic targets and other conventional treatments were performed first, and after washout for more than a month, tFUS for cerebellar targets and other conventional treatm
DoC patient group B:tFUS for cerebellar targets and other conventional treatments were performed first, and after washout for more than a month, tFUS for thalamic targets and other conventional treatm
Healthy subjects: thalamic tFUS group:Healthy subjects performed thalamic tFUS and cerebellar tFUS in random order, each stimulation was performed once, and the interval between the two different stim

Sponsors

The Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with disorders of consciousness: 1. Age >=18 years old; 2. Disturbance of consciousness caused by traumatic brain injury; 3. the course of disease >=2 weeks; 4. Vegetative State/unresponsive wakefulness syndrome (Vegetative State, CRS-R) according to clinical diagnostic criteria and Coma Recovery Scale-Revised (CRS-R) VS/ Unresponsive Wakefulness Syndrome (UWS) or Minimal Conscious State (MCS); 5. stable vital signs and no progressive neurological symptoms; 6. if the use of consciousness improving drugs for at least 2 weeks, no dose adjustment during the enrollment period; 7. Voluntary participation and signed informed consent. Healthy subjects: 1. Age >=18 years old; 2. no known disease or prescription medication, normal neurological examination; 3. Subjects with alcohol abuse, insufficient sleep, nervous system disease, cardiovascular disease, epilepsy, cochlear implant and other contraindications to transcranial magnetic stimulation were excluded; 4. voluntary participation and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe vascular sclerosis; 2. Intracranial hypertension, severe hydrocephalus, intracranial infection; 3. Metallic or electronic device implants (e.g., pacemakers, cochlear implants, deep brain stimulators, spinal cord stimulation, aneurysm clips, internal fixation devices after ventriculoperitoneal shunt, etc.); 4. Unstable heart disease and high blood pressure; 5. other serious diseases that may affect the study.

Design outcomes

Primary

MeasureTime frame
Coma Recovery Scale-Revised;

Secondary

MeasureTime frame
Full Outline of UnResponsiveness;Persistent Vegetative State Scale;electroencephalogram results;Computed Tomography results;Functional Near-Infrared Spectroscopy results;Functional Magnetic Resonance Imaging results;

Countries

China

Contacts

Public ContactXiquan Hu

The Third Affiliated Hospital of Sun Yat-sen University

huxiquan@mail.sysu.edu.cn+86 189 2210 2910

Outcome results

None listed

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