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Treatment of Shoulder Subluxation in Chronic Stroke Patients

NCT00628836 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-06-03

No results posted yet for this study

Summary

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.

Conditions

  • Shoulder Dislocation

Interventions

DEVICE

BION stimulation

The study will have two phases, each with a six week duration. During phase 1, the BION group will be implanted with BIONs in the middle deltoid and supraspinatus muscles. The muscles will be stimulated electrically by way of the BION and an external controller for one to two hours per day at 5pps in an on-off duty cycle train. The SE group will begin surface stimulation similar to that of BE group. Subjects in either group whose initial therapy in phase 1 successfully reduces the amount of shoulder subluxation to 5mm or less will go off stimulation for six weeks, and be reassessed whether subluxation is redeveloping. If a subject in either group does not respond sufficiently to phase 1 therapy, the participant will move to phase 2 where the shoulder will be stimulated at up to 25 pps either with surface stimulation (SE group) or BION stimulation (BE group) for another six weeks. At the end of phase 2, participants will go off stimulation for six weeks and then be reevaluated.

Sponsors & Collaborators

  • University of Southern California

    lead OTHER

Principal Investigators

  • Lucinda Baker, M.D. · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-06-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00628836 on ClinicalTrials.gov