NCT02930213

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 12, 2016

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

Enrollment Period

1.4 years

First QC Date

September 29, 2016

Last Update Submit

October 11, 2016

Conditions

Disorders of Consciousness

Keywords

unresponsive wakefulness syndromeminimally conscious statecircadian rhythmsfree-running period

Outcome Measures

Primary Outcomes (1)

  • 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)

Eligibility Criteria

Age39 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The investigators chossen patients with UWS or MCS.The subjects include 4 UWS and 3 MCS.

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Consciousness DisordersPersistent Vegetative State

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesUnconsciousness

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
8 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 29, 2016

First Posted

October 12, 2016

Study Start

January 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

October 12, 2016

Record last verified: 2016-10