Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Nerve Conduction Study - Distal Latency |
Motor nerve conduction studies are used to examine conduction of electrical impulses along nerves. Electrodes are placed on the skin in specific areas to evaluate peripheral nerves. An electrode stimulates a nerve while the receiving site records how well electrical impulses are being conducted along the nerve. Latency is the time it takes in milliseconds (ms) for the electrical impulse to travel to the site receiving the stimulation. |
Baseline, Month 12, Month 24 |
|
Primary |
Nerve Conduction Study - F Wave Latency |
Motor nerve conduction studies are used to examine conduction of electrical impulses along nerves. Electrodes are placed on the skin in specific areas to evaluate peripheral nerves. An electrode stimulates a nerve while the receiving site records how well electrical impulses are being conducted along the nerve. F wave latency is the time it takes in milliseconds (ms) for an electrical signal to travel from the stimulating electrode to the distal muscle and back to the stimulating site. F waves are used to assess polyneuropathy and F wave latency can be extended or even absent in persons with CIDP. |
Baseline, Month 12, Month 24 |
|
Primary |
Nerve Conduction Study - Conduction Velocity |
Motor nerve conduction studies are used to examine conduction of electrical impulses along nerves. Electrodes are placed on the skin in specific areas to evaluate peripheral nerves. An electrode stimulates a nerve while the receiving site records how well electrical impulses are being conducted along the nerve. Conduction velocity measures the rate of impulse conduction in meters per second (m/s) and is often decreased in patients with CIDP as myelination is affected. |
Baseline, Month 12, Month 24 |
|
Primary |
Nerve Conduction Study - Conduction Amplitude |
Motor nerve conduction studies are used to examine conduction of electrical impulses along nerves. Electrodes are placed on the skin in specific areas to evaluate peripheral nerves. An electrode stimulates a nerve while the receiving site records how well electrical impulses are being conducted along the nerve. Conduction amplitude is the size of the response to electrical stimulation, measured in millivolts (mV). Reduced amplitude indicates axon loss. |
Baseline, Month 12, Month 24 |
|
Primary |
Hand Grip Strength |
Hand grip strength is assessed with a Jamar Handheld Dynamometer for children ages 5-18 years and measures strength in kilograms (kg). Both right and left hand grip strength were measured and the best of three attempts were used for each hand. Increased hand strength is an indicator of effective treatment. |
Baseline, Month 6, Month 12, Month 18, Month 24 |
|
Primary |
Rasch-built Overall Disability Scale (R-ODS) for CIDP Score |
The Rasch-built Overall Disability Scale (R-ODS) used for those with Guillain-Barré syndrome (GBS), chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), and gammopathy-related polyneuropathy (MGUSP) is a 24-item scale asking respondents to rate how greatly polyneuropathy impacts activities. Responses are given on a scale of 0 to 2 where 0 indicates it is not possible for the respondent to perform the task and 2 means that the task can be performed without difficulty. Total scores range from 0 to 48 and higher scores indicate greater ability to perform daily and social tasks. |
Baseline, Month 6, Month 12, Month 18, Month 24 |
|
Secondary |
Tumor Necrosis Factor (TNF)-a |
The impact of treatment on serum cytokine profiles will be assessed by measuring TNF-a. Serum cytokine levels will be statistically analyzed on a per patient basis, with each patient's baseline measurements used for comparison. TNF-a is elevated in CIDP patients and a decrease in serum TNF-a is an indication of effective treatment. |
Baseline, Month 6, Month 12, Month 18, Month 24 |
|
Secondary |
Interleukin (IL)-1ß |
The impact of treatment on serum cytokine profiles will be assessed by measuring IL-1ß. Serum cytokine levels will be statistically analyzed on a per patient basis, with each patient's baseline measurements used for comparison. IL-1ß is elevated in CIDP patients and a decrease in IL-1ß values is an indication of effective treatment. |
Baseline, Month 6, Month 12, Month 18, Month 24 |
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