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

NCT00567541 | Completed Phase 2 Results

• 1 other identifier: CP-BBPM-001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Shoulder Pain Chronic

Keywords

shoulder; pain; stroke; subluxation

Outcome Measures

Primary Outcomes (1)

• Relief of Chronic Shoulder Pain

  Brief Pain Inventory (BPI) Question # 12 (rating pain at its worst in week prior to visit) was used to measure number of participants in whom BBPM provided any relief from chronic shoulder pain after implantation, as evidence by appropriate muscular contraction and/or paresthesia. BPI scale range is from 1 to 10, where 0 = 'no pain' and 10 = 'pain as bad as one can imagine'.

  From baseline to 48 week follow up

Study Arms (2)

Active BBPM stimulation

ACTIVE COMPARATOR

Therapeutic Stimulation is applied via the Battery Powered Microneuromodulator (BBPM) which is programmed to deliver set stimulation parameters with approximate frequency of 30 Hz, current 5mA for 200 microseconds for the first 12 weeks of the study. The BBPM is implanted near the axillary nerve within the quadrilateral space.

Device: Battery Powered Microneuromodulator (BBPM)

Sham BBPM stimulation

PLACEBO COMPARATOR

The Battery Powered Microneuromodulator is implanted near the axillary nerve within the quadrilateral space. The BBPM is programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, the device will be reprogrammed to deliver therapeutic stimulation over a 12 week period.

Device: Battery Powered Microneuromodulator (BBPM)

Interventions

Battery Powered Microneuromodulator (BBPM) DEVICE

The Battery Powered Microneuromodulator (BBPM) is programmed to deliver bursts of electrical stimulation to deliver therapeutic stimulation beginning with a frequency of 30Hz, current of 5mA, for 200 microseconds. These settings were applied to deliver greater or lesser intensity based on study arm (active vs placebo).

Also known as: Bioness Battery Powered Microneuromodulator

Active BBPM stimulation; Sham BBPM stimulation

Eligibility Criteria

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

You may qualify if:

• 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 \<5/5 on Manual Muscle Testing ipsilateral to the shoulder in which the subject has chronic pain
• Shoulder pain ≥ 6/10 (on 0-10 numeric rating scale (NRS) for worst pain in last week (BPI #12))
• Ability to give informed consent and understand study requirements
• Ability to quantify pain using a 0-10 numeric rating scale. (A screening tool will be used to ensure that participants can rate 3 common pain scenarios (mosquito bite, stubbed toe and broken bone) on a 0-10 NRS relative to each other.)
• Willing and able to understand and comply with all study-related procedures during the course of the study
• Motivated to maintain an accurate diary for the study duration

You may not qualify if:

• Hemineglect (i.e., extinguish to double simultaneous stimulation)
• Shoulder trauma or diagnosed shoulder pathology prior to stroke; history of any shoulder surgery, regardless of whether procedure preceded for followed stroke.
• Need to take \>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

Sponsors & Collaborators

• Bioness Inc: lead

Study Sites (3)

Rancho Los Amigos National Rehabilitation Center

Downey, California, 90242, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

The Center for Pain Relief

Charleston, West Virginia, 25301, United States

Location

MeSH Terms

Conditions

Pain; Stroke; Joint Dislocations

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries

Limitations and Caveats

Further study plans terminated due to high migration/adverse event rates Small sample size Didn't include socio-environmental factors which could affect subject's overall functionality Three different sites/subtle stimulator implantation variances

Results Point of Contact

• Title: Keith McBride, CTO
• Organization: Bioness

Keith.McBride@bioness.com

661-362-4866

Study Officials

• Andrew Friedman, MD

  Virginia Mason Seattle Main Clinic

  PRINCIPAL INVESTIGATOR

• Tim Deer, MD

  The Center for Pain Relief

  PRINCIPAL INVESTIGATOR

• Ziyad Ayyoub, M.D.

  Rancho Los Amigos National Rehabilitation Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2007
• First Posted: December 5, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: April 1, 2016
• Results First Posted: April 1, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)