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Treatment of Shoulder Subluxation in Chronic Stroke Patients

Primary Purpose

Shoulder Dislocation

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BION stimulation
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Dislocation focused on measuring Neuromuscular stimulator, Shoulder subluxation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rancho Los Angeles National Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

SE group

BE group

Arm Description

surface stimulation

BION stimulation

Outcomes

Primary Outcome Measures

Degree of shoulder subluxation by x-ray

Secondary Outcome Measures

Full Information

First Posted
February 25, 2008
Last Updated
June 1, 2015
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT00628836
Brief Title
Treatment of Shoulder Subluxation in Chronic Stroke Patients
Official Title
BION Implantable Microstimulation System
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
The BION™ is a novel implantable neuromuscular stimulator whose intended use in this study is to reanimate the shoulder muscles of stroke survivors with shoulder subluxation. Strokes are considered to be the most important cause of adult disability in North America, with 500,000 new cases per year in the U.S. (National Stroke Association) and 45,000 in Canada (Langton-Hewer, 1990; Shuaib & Hachinski, 1991). Three-quarters of these patients survive and half of the survivors have substantial muscle weakness after 6 months (Gresham et al., 1979) with little chance of spontaneous recovery (Anderson, 1990; Bonita & Beaglehole, 1988). The most commonly affected region in the early phases of recovery is the shoulder; 80% of hemiplegic stroke patients suffer from shoulder subluxation and associated chronic pain (Smith et al., 1980). The shoulder muscles that are normally active tonically are flaccidly paralyzed; the weight of the pendant arm gradually stretches and damages the atrophic muscles and ligaments, allowing the head of the humerus to descend out of the glenoid fossa. This results in chronic shoulder pain that is difficult to treat and tends to obstruct physical therapy directed toward regaining some use of the paretic arm. Our hypothesis is that electrical stimulation delivered by the BIONs should be fundamentally equivalent to muscle activation achieved voluntarily or by transcutaneous electrical nerve stimulation (TENS), but that the BIONs will prove to be a more clinically acceptable and effective approach. The BION system consists of the BION implants themselves, a controller that is operated by the study participant, and fitting hardware and software used by the clinician to implant, test, and program BION function. In this study, the BION will be used to reanimate the shoulder muscles of stroke survivors experiencing shoulder subluxation. The objective of this study is to evaluate the safety and efficacy of intramuscular stimulation of BIONs to correct established, symptomatic shoulder subluxation in chronic stroke survivors. The results of intramuscular stimulation by BIONs will be compared with the results of treatment with conventional therapy: surface stimulation. Degree of shoulder subluxation will be the primary outcome measure for the study. We have included other (secondary) outcome measures (i.e., muscle strength, range of motion, functional activity, spasticity/tone, subject satisfaction and pain) which may reveal secondary benefits of treatment with BIONs. The investigation is expected to last up to 21 weeks for each study participant. The study will be completed over a 5-year period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Dislocation
Keywords
Neuromuscular stimulator, Shoulder subluxation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SE group
Arm Type
Active Comparator
Arm Description
surface stimulation
Arm Title
BE group
Arm Type
Experimental
Arm Description
BION stimulation
Intervention Type
Device
Intervention Name(s)
BION stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Degree of shoulder subluxation by x-ray
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:1. Diagnosis of hemiplegic stroke at least 6 months prior to enrollment; Paresis of the shoulder muscles; Shoulder subluxation (i.e., a positive sulcus sign of 5 mm or more); Age 18 years or older; Stable use of pain medication for at least one month prior to enrollment; Medically stable; Able to travel to the testing center; Mentally capable to understand and carry out the procedures and communicate concerns; and Willing to participate and provide informed consent. Exclusion Criteria: Pregnant, nursing, or planning to become pregnant within the next four months; Presence of electronic implants (e.g., cardiac pacemaker, cochlear implant, neurostimulator, etc.); Presence of metallic implants in the immediate field of the magnetic coil: Use of using electrical stimulation for treatment of their subluxed shoulder in the past month; Inability to recruit muscles through surface electrical stimulation because of excessive adipose tissue; Presence of other unrelated shoulder problems; Severe hemineglect ( patient is unable to acknowledge or answer questions about the involved limb) Cancer or other serious illness, including a disease other then stroke resulting in dysfunction of movement. Subject is currently enrolled in another clinical trial or research study that involves therapy or intervention to the upper limb.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucinda Baker, M.D.
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rancho Los Angeles National Rehabilitation Center
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16711659
Citation
Loeb GE, Richmond FJ, Baker LL. The BION devices: injectable interfaces with peripheral nerves and muscles. Neurosurg Focus. 2006 May 15;20(5):E2. doi: 10.3171/foc.2006.20.5.3.
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Treatment of Shoulder Subluxation in Chronic Stroke Patients

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