Mayo Clinic increases Size of Calmare (Scrambler Therapy) Study from 100 to 150
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Scrambler Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy: An Open Access Trial
Resource links provided by NLM:
Genetics Home Reference related topics: Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies
MedlinePlus related topics: Peripheral Nerve Disorders
U.S. FDA Resources
Further study details as provided by Mayo Clinic:
Primary Outcome Measures:
Change in pain on a 0-10 numerical rating scale. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
Changes in neurologic function will be done by Neurometer Current Perception Threshold (CPT) testing and with a Rydel-Seiffer graduated tuning fork. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Patients will also undergo neurologic function testing. This will be done in an exploratory measure to try to correlate changes in the patient reported outcome instrument data with changes in the different measures of neurologic function. The two measures will be Neurometer Current Perception Threshold (CPT) Testing and testing with a Rydel-Seiffer graduated tuning fork.
What? They couldn't prove anything with 100 patients, so they go fishing by recruiting MORE patients?
Personally, I'd be more interested in seeing Dr. Campbell's results -- the results that were originally due a YEAR ago but which were postponed THREE times and were SUPPOSED to be available back in NOVEMBER -- over THREE MONTHS ago -- but of which not so much as a single word has been heard.
Certainly, the recent release of Dr. Swainey's results haven't generated much excitement now, have they?