the Prediction Value of Combined Electroencephalographic and Electromyographic Response in Disorders of Consciousness

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06922864

Enrollment

Registered

2025-04-11

Start date

2025-04-15

Completion date

2026-12-31

Last updated

2025-04-11

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

Conditions

Disorders of Consciousness Due to Severe Brain Injury

Brief summary

The goal of this observation study is to learn about the prediction value of combined electroencephalographic and electromyographic response in disorders of consciousness. The main ways of stimulation is thermal and itch. Six months after inclusion in the study, patients were classified according to the Glasgow Outcome Scale Extended, (GOSE).

Interventions

OTHERthermal stimulation

contact heat stimulation at 54℃

OTHERitch

itch the sole of the foot

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age ≥18 years. 2. Brain damage lasts 28 to 90 days. 3. It meets the diagnostic criteria of unresponsive arousal syndrome/vegetative state (UWS/VS) or microconscious state (MCS). Diagnostic criteria for UWS/VS: loss of cognitive function and inability to execute commands; There is a sleep-wake cycle; Inability to understand or express language; The ability to open eyes automatically or in response to stimulation; Can be purposeless eye following movement; The functions of hypothalamus and brainstem were basically preserved. MCS diagnostic criteria: simple instructions can be executed; Yes/no (whether correct or not) can be expressed by gesture or speech; Have an understandable language; Purposeful behavior (including activity or emotional response) with more than one can diagnose MCS. 4. All subjects' legal guardians sign informed consent forms.

Exclusion criteria

1. Spinal cord T1 and above plane injury, peripheral nerve injury and so on affect nerve conduction; 2. The impact of injury on palms and soles of feet; 3. History of developmental, psychiatric, or neurological disorders prior to brain injury. 4. Deep sedation within 72 hours, including the use of general anesthesia. 5. Increased intracranial pressure, liver/kidney failure, and hemodynamic instability within 72 hours. 6. Severe co-existing systemic diseases with limited life expectancy.

Design outcomes

Primary

Measure	Time frame
the state of consciousness	6 months

Secondary

Measure	Time frame
the score of GOSE	6 months

Contacts

Primary ContactHu

304517021@qq.com+86+15399059833

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026