NCT00205582

Brief Summary

Excitatory amino acids may be involved in secondary neuronal damage after traumatic brain injury. The amount of microglia activation is an indirect measure of neuronal damage. Micorglia activation will be measured R)-\[11C\]PK11195 PET 1 week, 1 month and 6 months after brain injury.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2001

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2001

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

November 4, 2005

Status Verified

May 1, 2001

First QC Date

September 12, 2005

Last Update Submit

November 3, 2005

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain InjuryPETmicroglia

Outcome Measures

Primary Outcomes (1)

  • Glasgow coma scale after 6 months

Secondary Outcomes (1)

  • microglia activation

Interventions

Positron Emission TomographyDEVICE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Traumatic Brain Injury 2. Age: 18-70 years 3. Haemodynamic and respiratory stable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VU University Medical Centre

Amsterdam, 1081 HV, Netherlands

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Tomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisImage EnhancementPhotographyRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Bart van Berckel, MD; PhD

    Amsterdam UMC, location VUmc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

May 1, 2001

Study Completion

December 1, 2004

Last Updated

November 4, 2005

Record last verified: 2001-05

Locations

NL(1)