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The goal of this randomized control trial is to test if growth hormone therapy is a safe and effective treatment for patients suffering from growth hormone deficiency and persistent post-concussion symptoms. The main questions it aims to answer are:
Is growth hormone therapy effective at mitigating persisting post-concussion symptoms in patients with growth hormone deficiency?
Is it feasible to conduct a larger trial to examine efficacy of growth hormone therapy in patients with persistent post-concussion symptoms and growth hormone deficiency?
Participants will be asked to complete an initial assessment for study inclusion and to complete clinical outcome questionnaires. If a participant meets study criteria they will be randomized to receive either growth hormone therapy (provided by Pfizer) or a placebo (provided by Pfizer). Participants will be instructed on how to self-administer their assigned drug daily for three months. Monthly follow-up visits will include a blood draw to measure a biomarker and clinical outcome questionnaires. At the final follow-up visit after three months, participants will learn what group they were assigned and given the option to complete the growth hormone therapy if they were originally assigned to the placebo group.
Researchers will compare the growth hormone therapy group to the placebo group to identify any potential differences in outcomes.
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Each clinical study has its own guidelines for who may participate, called eligibility criteria. These factors can include your age, sex, overall health, type and stage of disease, and personal treatment history. However, only the research study staff can determine if you qualify to enroll in the study.
Condition
Growth Hormone Treatment, Growth Hormone Deficiency, Concussion, Mild, Concussion Post Syndrome
Sex
Male or Female
Age
18 - 65 years