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Electrical Stimulation for the Treatment of Post-Stroke Shoulder Pain

NCT01094301 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2018-09-12

Study results available
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Summary

Post-stroke shoulder pain is defined as pain in the shoulder area that starts after a person has had a stroke. The SPR System is an investigational device that is being studied for the relief of post-stroke shoulder pain. The SPR System uses electrical stimulation and includes a Trial Stage (where a temporary system is used to see if the subject may benefit from this type of therapy) and may include an Implant Stage (where a small device is implanted under the skin in the chest). The SPR System delivers mild electrical stimulation to the shoulder where the subject feels pain. This research study will evaluate the effect of electrical stimulation on shoulder pain.

Individuals who are over the age of 21, who had a stroke at least six months ago, who experience shoulder pain, and have tried other therapies for their shoulder pain, may be eligible to participate in the first stage of the SPR System. Subjects meeting the specified success criteria at the conclusion of the SPR Trial Stage who experience a return of pain within 6 months of completion of the Trial Stage may be eligible for the second stage (SPR Implant Stage). This research study lasts a little over 3 years and may include 17 visits to the study doctor and at least 8 telephone calls from study staff.

Conditions

  • Shoulder Pain

Interventions

DEVICE

The SPR System

The SPR System is an investigational two-staged device which delivers stimulation to the shoulder. Subjects with chronic post-stroke shoulder pain who meet eligibility criteria for the first stage (SPR Trial Stage) will receive a temporary Lead and External Stimulator. Subjects who qualify and who agreed to proceed will advance to the second stage (SPR Implant Stage) which uses an Implantable Pulse Generator (IPG) and Implantable Lead. Subjects will be followed until 36-months after IPG stimulation has been started.

Sponsors & Collaborators

  • NDI Medical, LLC

    collaborator INDUSTRY

  • SPR Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2017-07-25
Completion
2017-07-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01094301 on ClinicalTrials.gov