Clinical Trials of Bions for Therapeutic Electrical Stimulation
Abstract
BlONs are individually addressable, single channel electrical stimulators that can be injected into one or more muscles through a 12-gauge hypodermic needle, They receive power and command signals from an externally worn RF transmission coil, Two clinical trials are underway to determine their safety and efficacy for strengthening atrophic muscles associated with stroke (7 patients accrued; 6 implanted) and chronic osteoarthritis of the knee (5 patients accrued; 3 implanted). In both studies, BIONs have proven easy for the clinician to implant and for the patients to use. Thresholds for recruitment of muscle contractions have remained stable and no adverse effects have been reported. Patients generally like the stimulation and most have elected to continue simulation after the prescribed study period. Stimulation at low frequencies for a total of about I hour/day has prod need demonstrable reversals of muscle atrophy as measured by imaging. In patients with radiological subluxation of the shoulder, the subluxation has been reduced. Preliminary indications suggest also that chronic pain has been reduced and locomotor function has improved in patients with knee osteoarthritis. Extensions of these studies to broader categories of patients and clinical problems are underway.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 25, 2001
- Accession Number
- ADA409771
Entities
People
- A. C. Dupont
- F. J. Richmond
- G. E. Loeb
- J. L. Creasy
- S. D. Bagg
Organizations
- University of Southern California