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

Primary Purpose

Shoulder Pain Chronic

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Battery Powered Microneuromodulator (BBPM)

About this trial

This is an interventional treatment trial for Shoulder Pain Chronic focused on measuring shoulder, pain, stroke, subluxation

Eligibility Criteria

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

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 <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

Exclusion Criteria:

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
History of adverse reactions to local anesthetic (e.g., lidocaine)

Sites / Locations

Rancho Los Amigos National Rehabilitation Center
Virginia Mason Medical Center
The Center for Pain Relief

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active BBPM stimulation

Sham BBPM stimulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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'.

Secondary Outcome Measures

Full Information

NCT ID

NCT00567541

First Posted

December 3, 2007

Last Updated

March 2, 2016

Sponsor

Bioness Inc

1. Study Identification

Unique Protocol Identification Number

NCT00567541

Brief Title

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

Acronym

BBPM

Official Title

Feasibility Study of the Bioness Battery-Powered Microneuromodulator (BBPM) to Treat Chronic Shoulder Pain in Chronic Post-Stroke Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bioness Inc

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This is a prospective, multi-center, randomized, controlled, double-blinded parallel study designed to evaluate feasibility and safety. The primary purpose of this study is to demonstrate the clinical feasibility of implanting the BBPM near a peripheral nerve for the treatment of chronic, intractable, pain in this case represented by chronic regional shoulder pain in hemiplegic stroke patients. This is a 48-week efficacy study with safety data collection throughout the study period and up to 2 years for all available subjects. Each study arm will receive therapeutic level stimulation for a total of 12 consecutive weeks (Weeks 1-12 for Active treatment group and Weeks 24-36 for the sham group) during the 48 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shoulder Pain Chronic

Keywords

shoulder, pain, stroke, subluxation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active BBPM stimulation

Arm Type

Active Comparator

Arm Description

Arm Title

Sham BBPM stimulation

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Battery Powered Microneuromodulator (BBPM)

Other Intervention Name(s)

Bioness Battery Powered Microneuromodulator

Intervention Description

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).

Primary Outcome Measure Information:

Title

Relief of Chronic Shoulder Pain

Description

Time Frame

From baseline to 48 week follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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 <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 Exclusion Criteria: 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 History of adverse reactions to local anesthetic (e.g., lidocaine)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew Friedman, MD

Organizational Affiliation

Virginia Mason Seattle Main Clinic

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Tim Deer, MD

Organizational Affiliation

The Center for Pain Relief

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ziyad Ayyoub, M.D.

Organizational Affiliation

Rancho Los Amigos National Rehabilitation Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rancho Los Amigos National Rehabilitation Center

City

Downey

State/Province

California

ZIP/Postal Code

90242

Country

United States

Facility Name

Virginia Mason Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

Facility Name

The Center for Pain Relief

City

Charleston

State/Province

West Virginia

ZIP/Postal Code

25301

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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