Shoulder Dislocation Clinical Trial
Official title:
BION Implantable Microstimulation System
The study looks at treatments for reversing chronic shoulder subluxation after a stroke. It compares electrical stimulation with surface electrodes (stimulation through the skin) with intra-muscular stimulation (from inside the muscle)using an implanted micro-stimulator (BION). Subjects are put either in a surface stimulation or a BION® group. In the BION® group, two BION®s are implanted in the shoulder, the medial deltoid and supraspinatus muscles. Treatment consists of a baseline of 6 weeks, and 6 weeks of therapy, consisting of 2 sessions per day for 10 to 30 minutes each time. This is followed by 6 weeks without therapy. If testing shows that after 6 weeks of therapy there is no reversal of subluxation, more intense therapy is carried out for another 6 weeks. Treatment is similar in the surface electrode group, but surface electrodes deliver the stimulation instead of BION®s. A total of 30 subjects is expected to complete the study.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria:1. 1. Diagnosis of hemiplegic stroke at least 6 months prior to enrollment; 2. Paresis of the shoulder muscles; 3. Shoulder subluxation (i.e., a positive sulcus sign of 5 mm or more); 4. Age 18 years or older; 5. Stable use of pain medication for at least one month prior to enrollment; 6. Medically stable; 7. Able to travel to the testing center; 8. Mentally capable to understand and carry out the procedures and communicate concerns; and 9. Willing to participate and provide informed consent. Exclusion Criteria: 1. Pregnant, nursing, or planning to become pregnant within the next four months; 2. Presence of electronic implants (e.g., cardiac pacemaker, cochlear implant, neurostimulator, etc.); 3. Presence of metallic implants in the immediate field of the magnetic coil: 4. Use of using electrical stimulation for treatment of their subluxed shoulder in the past month; 5. Inability to recruit muscles through surface electrical stimulation because of excessive adipose tissue; 6. Presence of other unrelated shoulder problems; 7. Severe hemineglect ( patient is unable to acknowledge or answer questions about the involved limb) 8. Cancer or other serious illness, including a disease other then stroke resulting in dysfunction of movement. 9. Subject is currently enrolled in another clinical trial or research study that involves therapy or intervention to the upper limb. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Rancho Los Angeles National Rehabilitation Center | Downey | California |
Lead Sponsor | Collaborator |
---|---|
University of Southern California |
United States,
Loeb GE, Richmond FJ, Baker LL. The BION devices: injectable interfaces with peripheral nerves and muscles. Neurosurg Focus. 2006 May 15;20(5):E2. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Degree of shoulder subluxation by x-ray | 6 weeks | No |
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