Understanding growth hormone deficiency after a brain injury in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study observes adults with mild to moderate/severe traumatic brain injury to see how growth hormone deficiency relates to quality of life, fatigue, mood, and sleep. Participants complete baseline questionnaires and undergo provocative testing for GHD. If GHD is diagnosed, some may receive growth hormone replacement and be followed for 12 weeks to assess change in symptoms and quality of life. The study also explores whether a QoL-AGHDA score can help predict GHD and measure treatment response. No experimental interventions are required other than standard clinical testing and observational follow-up.

Why it matters

Who can join: the full rules

Inclusion criteria: Adults aged 18-70 years must be referred and have a diagnosis of mTBI made by a brain injury specialist physician and meet the 2023 ACRM diagnostic criteria (Appendix A, Panel A) or the NIH diagnostic criteria for moderate/severe TBI (Appendix A, Panel B). All participants must be symptomatic for at least one-year post-injury (determined by the Glasgow Extended Scale score of less than 8 for moderate/severe TBI and a Rivermead Post-Concussion Questionnaire score of \> 13 with 3 or more symptoms scored \> 3 for mTBI), at the time of screening. All participants must also be fluent in English and be able to either complete questionnaires online or over the phone.

In terms of concomitant therapies and medication, all prescription and non-prescription medications (e.g., over-the-counter drugs and herbal supplements) and therapies will be recorded by participants during baseline assessments. Participants with GHD on treatment will be asked to disclose any changes in medications/and or therapies at each bi-weekly follow up questionnaires.

Exclusion criteria include untreated pituitary deficits to minimize confounding factors (unless treated/consulted with Dr. Debert and/or Dr. Lithgow), other intracranial abnormalities, chronic neurological conditions, untreated medical conditions, major medical conditions in the past 6 months such as stroke, and current or planned pregnancy.

Where it's running

• University of Calgary
  Calgary, Alberta, Canada Recruiting
• Foothills Medical Center, Main Floor Special Services
  Calgary, Alberta, Canada Not yet recruiting

Study contacts

• Principal investigator: Chantel T Debert, MD MSc FRCPC CSCN — University of Calgary
• Study coordinator: Chantel T Debert, MD MSc FRCPC CSCN
• Email: cdebert@ucalgary.ca
• Phone: (403) 944-4500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.