This is a randomized, double-blind, placebo-controlled, parallel-group trial with an open-label extension to evaluate the efficacy of growth hormone (GH) on cognitive functions of retired professional football players with growth hormone deficiency (GHD).
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
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
Parallel
Growth Hormone
Biological/VaccineDaily self-injections by subjects: 1-year double-blind phase; 6-month open-label extension for those who received placebo during the double-blind phase
Placebo
Other interventionDaily self-injections by subjects: 1-year double-blind phase
Cognitive functions- Working Memory
To assess change in working memory from base line to 1 yr post-treatment. Working memory will be reported as an index score based on scaled scores for the digit span subtest and symbol span subtest. Index scores have a mean of 100 and a standard deviation of 15. The typical range of index score is 45 to 155. Higher scores reflect better functioning. The scaled scores have a mean of 10 and a standard deviation of 3. Scores range from 1 to 19. Higher scores reflect better functioning.
Cognitive functions- Processing Speed
To assess change in Processing Speed from baseline to 1 yr post-treatment. Processing speed will be reported as an index score based on scaled scores of digit symbol subtest and symbol search subtest. Index scores have a mean of 100 and a standard deviation of 15. The typical range of index score is 45 to 155. Higher scores reflect better functioning. The scaled scores have a mean of 10 and a standard deviation of 3. Scores range from 1 to 19. Higher scores reflect better functioning. Trail Making Test A will also be used to assess processing speed. Reported as T-score. Higher scores reflect better performance.
Cognitive functions- Executive Function.
To assess change in Executive Function from baseline to 1 yr post-treatment. Trail Making Test B and verbal fluency (letter and category) will be used to assess executive function. Reported as T-score. T scores have a mean of 50 and a standard deviation of 10. Scores range from 13 to 87. Higher scores reflect better performance.
Cognitive functions- Verbal learning and memory
To assess change in Verbal learning and memory from baseline to 1 yr post-treatment. California verbal learning test will be used to assess this outcome measure. Reported as a standard score with a mean of 0 and a standard deviation of 1. Scores range from -0.5 to +5.0. Higher scores reflect better performance.
Quality of Life Assessment of Growth Hormone Deficiency in Adults
This measure includes a scale: It is based on the Adult Growth Hormone Deficiency Assessment (AGHDA) QoL questionnaire. It consists of 25 yes/no questions. Score ranges from 0-25 with number of "yes" responses indicating score. A score of 8 or higher is typical of untreated adult GH deficiency. Treatment, on an average, results in a decrease of 2.5 to 3 points on the scale at one year
Change in QEEG Markers- power spectra
Spectral markers include delta (1-5-2.5 Hz), theta (3.5-7.5 Hz), alpha (7.5-12.5 Hz), alpha 1 (7.5-10.0 Hz), alpha 2 (10.0-12.5 Hz), beta 1 (12.5- 25.0 Hz) , beta 2 (25.0-35.0 Hz), gamma (35.0- 50.0 Hz). The power will be averaged over all electrode sites as absolute and relative power.
Change in QEEG Markers- Connectivity Measures
Connectivity measures will include Pearson product moment correlation for the time series and coherence, phase synchronization and phase lag.
MRI
To assess changes in volumetric MRI measurements and diffusion tensor imaging (DTI) measurements
MR imaging analysis of hypothalamus and pituitary
for diagnosis of GHD or multiple anterior pituitary hormone deficiencies in GHD - professional football players with TBI
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Center for Neurological Studies
Lead sponsor
Novo Nordisk A/S
Collaborator
