NCT00006270

Brief Summary

OBJECTIVES: I. Determine the randomness of adrenocorticotropic hormone (ACTH) and cortisol secretion using approximate entropy in patients who have sustained a head injury. II. Determine the correlation between randomness of ACTH and cortisol secretion and stages of sleep in these patients.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1998

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2000

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 2003

First QC Date

September 11, 2000

Last Update Submit

June 23, 2005

Conditions

Brain InjuryCraniocerebral Trauma

Keywords

brain injuryneurologic and psychiatric disordersrare disease

Interventions

cosyntropinDRUG
metyraponeDRUG

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Patients who have sustained head injury Closed head injury from trauma OR Vascular accidents like strokes and hemorrhages --Prior/Concurrent Therapy-- Endocrine therapy: No concurrent cortisol replacement Other: No blood donation during and for 1 month after study --Patient Characteristics-- Hematopoietic: Hemoglobin normal Other: * No hypopituitarism * No body mass index of 28 or greater * Not pregnant or nursing * Must have normal menstrual cycles * No severe mental impairment * Must not require legal guardian

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Transitional Learning Community

Galveston, Texas, 77550, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0209, United States

Location

MeSH Terms

Conditions

Brain InjuriesCraniocerebral TraumaNeurologic ManifestationsMental DisordersRare Diseases

Interventions

CosyntropinMetyrapone

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

Adrenocorticotropic HormoneMelanocortinsPro-OpiomelanocortinHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteinsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Randall Urban

    University of Texas

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

September 11, 2000

First Posted

September 12, 2000

Study Start

February 1, 1998

Last Updated

June 24, 2005

Record last verified: 2003-12

Locations

US(2)