Growth hormone therapy for retired football players with brain injuries
Interventional Study of Growth Hormone Replacement Therapy in Retired Professional Football Players With Growth Hormone Deficiency
PHASE2 · Center for Neurological Studies · NCT04121780
This study is testing if growth hormone therapy can help retired football players with brain injuries improve their memory and thinking skills.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years to 76 Years |
| Sex | Male |
| Sponsor | Center for Neurological Studies (other) |
| Locations | 1 site (Dearborn, Michigan) |
| Trial ID | NCT04121780 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled trial aims to evaluate the effects of growth hormone replacement therapy (GHRT) on cognitive functions in retired professional football players diagnosed with growth hormone deficiency (GHD) following traumatic brain injury (TBI). The study will assess memory, executive function, and attention using various methodologies, including the adult growth hormone deficiency assessment questionnaire, quantitative electroencephalogram, and magnetic resonance imaging. Participants will receive either GH or a placebo, with the potential for an open-label extension phase to further explore the therapy's benefits.
Who should consider this trial
Good fit: Ideal candidates are retired NFL players under 76 years old who have been diagnosed with GHD and have been retired for at least one year.
Not a fit: Patients with pre-existing brain diseases, significant comorbidities, or those who are not deficient in cortisol, testosterone, or thyroid hormones may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could improve cognitive functions and quality of life for retired football players suffering from GHD and TBI.
How similar studies have performed: While growth hormone therapy has shown benefits in other contexts, this specific application for retired football players with GHD and TBI is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The subject is willing to provide a signed and dated informed consent indicating that he understands the purpose and procedures required for the study and is willing to participate in the study. * Former NFL player * At least one year since retirement from football * Less than 76 years of age * Diagnosis of GHD on clinical grounds by a neurologist and an endocrinologist GHD Exclusion Criteria: * History of pre-existing brain disease other than concussion or TBI * History of a premorbid disabling condition that interferes with outcome assessments * Contraindication to GH therapy * Type I and II Diabetes mellitus * Active malignant disease * Acute critical illness, heart failure, or acute respiratory failure * Subjects who are deficient in cortisol, testosterone or thyroid at screening will be excluded until hormone abnormalities have been corrected.
Where this trial is running
Dearborn, Michigan
- Center for Neurolgoical Studies (CNS) — Dearborn, Michigan, United States (RECRUITING)
Study contacts
- Principal investigator: Randall R Benson, MD — Vice President and Medical Director
- Study coordinator: Vijay M Baragi, Ph.D.
- Email: vijay@neurologicstudies.com
- Phone: 313-228-0930.
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: TBI, Concussion, Brain, Sport Injury, Anterior Pituitary Hyposecretion Syndrome, Hypopituitarism, Growth Hormone Deficiency, GHD, Growth Hormone