week 11 part 2 Flashcards
Why are clinical trials necessary?
- Spontaneous recovery
- Placebo effect
- Safety
What is spontaneous recovery?
- Complete paralysis often occur immediately after SCI, but after time, spontaneous recovery can occur
- Rate of recovery greatest at 1st 3 months, but can continue for over a year
Placebo effect
- Patients with SCI are often desperate for recovery
2. Patients treated with placebo often report an improvement
What is the safety of the clinical trials?
- danger that treatment do not work effectively
2. Danger that treatment can be harmful (tumour, syingomyelia)
Phase 0
- Pharmacokinetics and toxicity of IND*
2. Very small number (~10 healthy individually)
Phase I
- Safety
2. Small number (20-100) of patients provided with treatment
Phase II
- Positive effect
2. Compare patients treated vs control in a larger cohort (100-300)
Phase III
- Positive effect in large cohort
2. Compared patients treated vs control in a large cohort (300-3,000)
What is the purpose of AIS?
- Standardize careful, detailed documentation of spinal cord injuries
- Guide further radiographic assessment and treatment
- Determine whether injuries are complete or incomplete
- Help predict recovery of autonomic function such as bowel, bladder, cardiovascular, respiratory and reproductive function
What does AIS consist of?
- Myotomal-based motor examination
- Dermatomal based sensory examination
- Anorectal examination
What does the sensory examination of AIS evaluate?
- 28 specific dermatomes bilaterally for light touch (generally a piece of cotton) and pinprick (generally a clean safety pin) sensation
What are the different grades for AIS?
- A grade of 0 - absent sensation
- A grade of 1 - impaired or altered sensation
- A grade of 2 - normal sensation
What does the motor examination consist of?
- Grading 5 specific muscle groups in the upper extremities and 5 specific muscle groups in the lower extremities
What is a complete spinal cord injury defined as?
- The absence of all motor and sensory function
2. Designated as being Grade A on the AIS
What is incomplete injury defined as?
- Some degree of retained motor or sensory function below the site of injury