NCT03181373

Brief Summary

Longitudinal descriptive study of a cohort of twenty brain-damaged patients for a two years period.

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 below P25 for all trials

Timeline
Completed

Started Sep 2014

Longer than P75 for all trials

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

September 26, 2014

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 8, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

June 8, 2017

Status Verified

May 1, 2017

Enrollment Period

3.8 years

First QC Date

May 9, 2017

Last Update Submit

June 7, 2017

Conditions

Brain-damaged Patients

Keywords

Craniocerebral injuryMild and severe brain traumatic injuryNeuropsychological abilitiesClinical assessmentAnatomical and functional imaging

Outcome Measures

Primary Outcomes (1)

  • Changes in Baseline standardized volume of the white matter fascicles

    determined on the "iplan" software. Baseline measured at 3 months after brain traumatic injury.

    at 3, 12 and 24 months

Secondary Outcomes (2)

  • Measure of the volume of activations clusters

    at 3, 12 and 24 months

  • Location of activation clusters

    at 3, 12 and 24 months

Study Arms (1)

Traumatic brain injury population

Defined population : traumatic brain injury population

Other: Cognitive rehabilitation program

Interventions

Cognitive rehabilitation programOTHER

Rehabilitation

Traumatic brain injury population

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with traumatic brain injury

You may qualify if:

  • Adult patients, over the age of 18.
  • Mild traumatic brain injury (Initial Glasgow score between 9 and 12)
  • Severe brain injury (Initial Glasgow score between 3 and 8),
  • Diffuse axonal injury and/or focal lesions.

You may not qualify if:

  • Patients with MRI contraindications,
  • Antecedents of brain lesions,
  • Important lesions of the lobes and cortex on cerebral CT,
  • Anoxic lesions related to cardiorespiratory arrest,
  • Must be able to perform neuropsychological tests,
  • Visual and auditory impairments.
  • Aphasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

Location

MeSH Terms

Conditions

Craniocerebral TraumaLymphoma, Follicular

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and InjuriesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2017

First Posted

June 8, 2017

Study Start

September 26, 2014

Primary Completion

July 1, 2018

Study Completion

December 1, 2018

Last Updated

June 8, 2017

Record last verified: 2017-05

Locations

FR(1)