Conditions: Brain Injuries Growth Hormone Deficiency
Keywords: traumatic brain Injury, cognitive function
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 10
Healthy volunteers: no

Brief summary:
To establish the effects of genotropin replacement on cognitive function in patients with severe growth hormone deficiency after traumatic brain injury.

Detailed description:
The study was terminated on 15-Dec-2008 due to an inability to recruit the protocol specified patient population. The study has not been terminated due to any safety concerns.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Genotropin intervention 2: Placebo
Intervention descriptions: intervention 1: Subcutaneous injection, starting dose 0.2mg/day for males and 0.3mg/day for female with dose titration at 0.1mg to 0.2 mg increments in accordance to IGF-1 results for a total duration of 36 weeks. intervention 2: Subcutaneous injection, with dummy dose titration for a total duration of 36 weeks.

Protocol document: