Electrical Stimulation for the Treatment of Post-Stroke Shoulder Pain

SPR Therapeutics

Status: Completed

Conditions: Shoulder Pain

Treatments: Device: The SPR System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01094301

NDI-0122-CSP-001

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Trial Stage Inclusion Criteria:

• At least 21 years of age
• Post-stroke shoulder pain

Trial Stage Exclusion Criteria:

• Use of habit-forming (narcotic) medications
• History of recurrent skin infections
• Bleeding disorder
• Parkinson's Disease, Spinal Cord Injury, traumatic brain injury, Multiple Sclerosis, or complex regional pain syndrome
• Heart arrhythmia or artificial heart valves
• Uncontrolled seizures
• Implanted Electronic Device

Implant Stage Inclusion Criteria

• Had a "return of pain" defined as an increase in pain of at least 2 points compared to the pain intensity score at Visit 5 and has a pain intensity score of at least 4

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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28 participants in 1 patient group

The SPR System

Experimental group

Description:

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.

Treatment:

Device: The SPR System