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Clinical study for trigeminal nerve electrical stimulation on wakefulness in patients with disturbance of consciousness

Clinical study for trigeminal nerve electrical stimulation on wakefulness in patients with disturbance of consciousness

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025573
Enrollment
Unknown
Registered
2019-09-01
Start date
2019-09-01
Completion date
Unknown
Last updated
2019-09-02

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

Conditions

Disturbance of consciousness

Interventions

A:Conventional awakening approaches
B:Combination of conventional awakening approaches and trigeminal nerve electrical stimulation

Sponsors

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Medical history of hypoxic ischemic encephalopathy (HIE), and HIE is the only cause of disturbance of consciousness; 2) CT/MRI imaging examination suggests hypoxic hypo-perfusion in the brain; 3) The course of disease is more than 3 months, the Glasgow coma scale (GCS) score <= 8 points, and the Coma Recovery Scale-Revised, CRS-R) scale is rated as vegetative state (VS) or Minimum consciousness state (MCS); 4) Right-handed, stable vital signs, no serious arrhythmia or history of implanted pacemaker, no pregnancy or uncontrollable epilepsy; 5) Aged 18 to 65 years.

Exclusion criteria

Exclusion criteria: 1) Infarction or hemorrhage of brain stem; 2) Patients with a history of mental illness and history of alcohol abuse.

Design outcomes

Primary

MeasureTime frame
Glasgow Coma Scale, GCS;

Secondary

MeasureTime frame
Glasgow Outcome Scale, GOS;Coma Recovery Scale-Revised, CRS-R;Blood/cerebrospinal fluid testing;Brain magnetic resonance examination;

Countries

China

Contacts

Public ContactMa Chao

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

ma_chao99@126.com+86 18127880016

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026