Phase 2 N=16 Randomized Triple-blind Treatment

An Implantable Microneuromodulator for the Treatment of Chronic Shoulder Pain in Chronic Post-Stroke Subjects

Shoulder Pain Chronic

Bottom Line

View on ClinicalTrials.gov: NCT00567541 ↗

Enrolled (actual)

Serious AEs

50.0%

Results posted

Apr 2016

Primary outcome: Primary: Relief of Chronic Shoulder Pain — 0; 0 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Battery Powered Microneuromodulator (BBPM) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bioness Inc
Primary completion: Dec 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Relief of Chronic Shoulder Pain	0; 0	—

Summary

The goal of this research study is to investigate safety and gather initial effectiveness data for a new implanted device designed to treat chronic shoulder pain in chronic post-stroke subjects. The BBPM weighs less than 0.03 ounces and measures 1" x 0.1". It is implanted into the shoulder to stimulate the axillary nerve. Stimulation of this nerve may reduce shoulder pain, reduce shoulder subluxation, improve motion, improve function, and possibly decrease use of pain medication. CAUTION--Investigational device. Limited by Federal law to investigational use.

Eligibility Criteria

Inclusion Criteria

18 years of age or older
Chronic post-stroke duration greater than or equal to 6 months
Unilateral hemiplegic shoulder pain persisting for ≥6 months
Hemiparesis (shoulder abduction graded 1 pain medication (opioid or non-opioid) for shoulder pain
Regular use of pain medication for chronic pain other than shoulder pain
Anticoagulated (taking warfarin or heparin, including fractionated heparin) or has a bleeding disorder
Unable, per their prescribing physician, to stop antiplatelet medications (e.g., aspirin, ticlopidine (Ticlid), clopidogrel (Plavix), tirofiban (Aggrastat), and eptifibatide (Integrilin)) for at least 7 days prior to device implantation.
Cardiac pacemaker
Implanted neurostimulator (e.g., spinal cord, deep brain, vagus nerve) or implanted pump or infusion device
Prosthetic heart valve or valvular heart disease requiring antibiotic prophylaxis
History of cardiac arrhythmia with hemodynamic instability
Uncontrolled seizures (> 1 seizure per month)
Pregnant or plan on becoming pregnant during the study period
Medical instability
Currently require, or likely to require, diathermy
Currently require, or anticipated to require, MRI within 8 weeks of projected device implantation date
History of adverse reactions to local anesthetic (e.g., lidocaine)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00567541). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.