Treatment of Shoulder Subluxation in Chronic Stroke Patients

NCT00628836 | Completed Phase 1

• 1 other identifier: BT3
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Dislocation

Keywords

Neuromuscular stimulator; Shoulder subluxation

Outcome Measures

Primary Outcomes (1)

• Degree of shoulder subluxation by x-ray

  6 weeks

Study Arms (2)

SE group

ACTIVE COMPARATOR

surface stimulation

Device: BION stimulation

BE group

EXPERIMENTAL

BION stimulation

Device: BION stimulation

Interventions

BION stimulation DEVICE

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.

BE group; SE group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Rancho Los Angeles National Rehabilitation Center

Downey, California, 90242, United States

Location

Related Publications (1)

• 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.

  PMID: 16711659 RESULT

MeSH Terms

Conditions

Shoulder Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries

Study Officials

• Lucinda Baker, M.D.

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 25, 2008
• First Posted: March 5, 2008
• Study Start: June 1, 2001
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 3, 2015

Record last verified: 2015-06

Locations

US (1)