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Completed

NCT Number: NCT02930213

The Core Body Temperature Rhythms: Distinguishing MCS From UWS

In this study, the core body temperature of 7 disorders of consciousness ( DOC ) patients were measured every 2 hour for 168 h .

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Key information

Conditions

Disorders of Consciousness Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Consciousness Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Persistent Vegetative State Signs and Symptoms Unconsciousness

Age range

39 year–69 year

Sex eligibility

All sexes

Study type

Observational

About this study

Living beings have multicomponent biological rhythms. There was a research recorded 24-h virations in electroencephalographic patterns. In normal subjects, the circadian rhythms of core body temperature is close to 24 h. When the interference of environmental and mental elements were eliminated, circadian rhythm shows the endogenous circadian rhythm of body acquiescently (>24h ), which is also called free-running period.

Measuring the continuous external auditory canal temperature of 4 unresponsive wakefulness syndrome (UWS) and 3 minimally conscious state(MCS) on the fluorescent lamp surrounding every 2 hours for 168 hours starting at 00:00 on the first day to address circadian capabilities.

Researchers expected to see the difference between MCS and UWS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients in minimally conscious state
  • patients with stable condition
  • patients free of sedative drugs and Na+ or Ca++ blockers (e.g., carbamazepine) or NMDA receptor antagonist (e.g., dextromethorphan)

Exclusion criteria

  • premorbid neurology antecedent
  • patients in coma or vegetative state
  • patients < 1 months after the acute brain injury

Treatment and study plan

Primary outcomes

  1. Measuring the continuous external auditory canal temperature

    Time frame: Continuous temperature measurements for 168 hours (8days)

    VS patients have core body temperature periods which are longer than 24 hours; whereas MCS patients are shorter than 24 hours.

Sponsors and collaborators

Lead sponsor

Jing Wang

Other

Registry information

Official study title

The Core Body Temperature Rhythms:A Promising Indicator of Distinguishing MCS From UWS

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 12, 2016
Registry last updated
Oct 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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