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Characterizing Growth Hormone Deficiency in Traumatic Brain Injury: Evaluation of the Growth Hormone in Adult Quality of Life Questionnaire

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

The goal of this observational study is to characterize the impact of growth hormone deficiency (GHD) on quality of life, symptom burden, and sleep in adults with traumatic brain injury (TBI), and to evaluate whether these outcomes improve with growth hormone replacement therapy. The main questions it aims to answer are: * Does quality of life, as measured by the Quality of Life Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA), differ between adults with TBI and GHD compared to those with TBI and no GHD? * Do fatigue, cognition, mood, post-concussion symptoms, body image, libido, perceived stress, and sleep architecture differ between these two groups? * Among participants with GHD who begin growth hormone replacement therapy, do symptom burden and quality of life improve over a 12-week treatment period? Eligible participants will be asked to complete baseline questionnaires and undergo testing for growth hormone deficiency (glucagon stimulation testing). A subset of participants will also complete objective sleep assessments using actigraphy and at-home polysomnography. For those who are diagnosed with growth hormone deficiency and choose to pursue treatment, questionnaires will be repeated bi-weekly while receiving growth hormone replacement therap

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
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• 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.

Locations
Other Locations
Canada
Foothills Medical Center, Main Floor Special Services
NOT_YET_RECRUITING
Calgary
University of Calgary
RECRUITING
Calgary
Contact Information
Primary
Chantel T Debert, MD MSc FRCPC CSCN
cdebert@ucalgary.ca
(403) 944-4500
Backup
Christina Campbell, MSc
christina.campbel1@ucalgary.ca
403-944-8649
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2028-11-01
Participants
Target number of participants: 200
Treatments
Suspected Growth Hormone Deficiency
Participants attending the Calgary Brain Injury Program or Chronic Pain Centre with persistent post-concussion symptoms for over 1 year suspected of having GHD.~Participants will be asked to complete the QoL-AGHDA and additional post-concussion symptom questionnaires and referred to endocrinology for provocative testing (glucagon stimulation testing)
Growth Hormone Deficiency Treatment
Participants with GHD (peak GH of \< 5 mcg/L following glucagon stimulation test (GST) will be provided with growth hormone replacement (Genotropin, starting dose 0.2 ug/L and 0.3ug/L for women taking exogenous oral estrogen, Pfizer) for 3 months.~Participants will repeat the QoL-AGHDA and exploratory outcome questionnaires bi-weekly throughout treatment (3-months).
Sponsors
Collaborators: Pfizer
Leads: University of Calgary

This content was sourced from clinicaltrials.gov

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