The Core Body Temperature Rhythms: Distinguishing MCS From UWS

Disorders of Consciousness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02930213
• Other study ID #: CX2014128
• Status: Completed
• Phase: Phase 2
• First received: September 29, 2016
• Last updated: October 11, 2016
• Start date: January 2015
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: Hangzhou Normal University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 39 Years to 69 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Consciousness Disorders
• Disorders of Consciousness

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jing Wang

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring the continuous external auditory canal temperature	VS patients have core body temperature periods which are longer than 24 hours; whereas MCS patients are shorter than 24 hours.	Continuous temperature measurements for 168 hours (8days)	Yes