Shoulder DislocationPhase 1NCT00628836
Treatment of Shoulder Subluxation in Chronic Stroke Patients
A Phase 1 study testing BION stimulation in people with Shoulder Dislocation, run by University of Southern California at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Shoulder Dislocation
- What is being tested?
- BION stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2001to Dec 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rancho Los Angeles National Rehabilitation Center
Downey, California, 90242
About this study
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.
Read the 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.
- Conditions
- Shoulder Dislocation
- Being tested
- BION stimulation
- Keywords
- Neuromuscular stimulator, Shoulder subluxation
- Medical subject headings
- Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BION stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| SE group | Active comparator | surface stimulation Receives: Device: BION stimulation |
| BE group | Experimental | BION stimulation Receives: Device: BION stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of shoulder subluxation by x-ray
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startJun 2001
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder DislocationStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerald E. Loeb, M.D., University of Southern California
- Investigators
- Lucinda Baker, M.D., Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628836
- Sponsor's protocol ID
- BT3
- Status last verified
- Jun 2015
- First submitted
- 25 Feb 2008
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16711659
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BION Implantable Microstimulation System
- ClinicalTrials.gov ID
- NCT00628836
- Acronym / sponsor ID
- BT3
- Conditions
- Shoulder Dislocation
- Keywords
- Neuromuscular stimulator, Shoulder subluxation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Jun 2001
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 5 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SE group | Active comparator | Device: BION stimulationsurface stimulation |
| BE group | Experimental | Device: BION stimulationBION stimulation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BION stimulationThe 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. | Device | BE group, SE group |
Primary outcome
Degree of shoulder subluxation by x-ray
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
- Results publication: PubMed 16711659Loeb 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucinda Baker, M.D. principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BION stimulation in people with Shoulder Dislocation, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of shoulder subluxation by x-ray (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00628836, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.