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Completed

NCT Number: NCT01512524

Hormonal Deficiency in the Quality of Life of Patients With Traumatic Brain Injury

The primary objective is to assess the long-term impact of hormonal deficiency on Quality of Life (QoL) in a large group of moderate and severe Traumatic Brain Injury (TBI) patients.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

French University Hospital

Lyon, Auvergne-Rhône-Alpes, 69000, France

About this study

Severe Traumatic Brain Injury, when not leading to mortality, is a major cause of morbidity in early adulthood.

Recent studies have demonstrated a previously unappreciated association between Severe Traumatic Brain Injury and endocrine dysfunction.

The current trial aims at evaluating the quality of life 18 months post-trauma and associating this outcome to growth hormone levels.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All subjects must be between the ages of 18-65
  • Documented moderate to severe Traumatic Brain Injury (TBI) at less than 4 months post injury.
  • Glasgow Coma Scale (GCS) equal to or greater than 12
  • Patients volunteer to participate in the study, with a written informed consent signed
  • BMI between 17 kg/m2 - 30kg/m2
  • Affiliation to a national health insurance program

Exclusion criteria

  • Glasgow Coma Scale (GCS) ≥13
  • History of TBI ≥4 months
  • Anterior hypopituitarism documented
  • History of radiotherapy
  • Liver dysfunction: total bilirubin <20µmol/l and/or factor V<60%)
  • Renal dysfunction: creatinine clearance < 30 ml/mn (Cockcroft & Gault)
  • Anyone who is currently taking or who has taken corticotherapy in the last 4 weeks before TBI
  • Pregnancy
  • Contraindications to MRI:
  • Patients who have a heart pacemaker
  • Patients who have a metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain
  • Patients with severe claustrophobia

Treatment and study plan

MRI scan and endocrinology analysis

Other

Endocrinology analysis including statique and dynamic exams, neuropsychologic evaluations and IRM scan.

Other names: MRI scan, endocrinology analysis

Primary outcomes

  1. Evolution of the SF-36(Short-Form health survey)score up to 18 months post-trauma

    Time frame: assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.

Secondary outcomes

  1. QOLIBRI (Quality of Life after Brain Injury) measure #1

    Time frame: assessed at 4 months (M4), 12 months (M12)and 18 months (M18) after brain injury.

  2. Questions on Life Satisfaction-Hypopituitarism (QLS-H) measure #2

    Time frame: Time frame: assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.

  3. Tests of Attentional, mnesic and executive performances #3

    Time frame: assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.

    Tests of Attentional, mnesic and executive performances: - Alertness

    • Sustained Attention
    • Divided Attention
    • Go/NoGo
    • Working Memory
    • Incompatibility
    • Flexibility
    • Grober and Buschke test
    • Rey's complex figure (copy and memory)
  4. Functional outcomes (#4):The Glasgow Outcome Scale (GOS)-Score

    Time frame: assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.

  5. Functional outcome #5 :the Functional Independence Measure (FIM)

    Time frame: assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Long Term Follow-up of Moderate and Severe Traumatic Bain Injury and Assessment of Involvement of Hormonal Deficiency in the Quality of Life

Acronym: INSPIRE-TC

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Jan 19, 2012
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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