SBIR-STTR Award

The objective of this research is to establish the feasibility of the design and cost effective fabrication of a miniature, skin-mounted neurostimulator. The stimulator will be used to deliver up to three channels of electrical stimulation through percutaneous electrodes implanted in muscle to provide post-surgical active motion therapies and for numerous future clinical applications. The long-term goal of this project is to develop and commercialize a percutaneous electrical stimulation system for application of temporary therapy. The product we are developing will enable a physician to deliver via intramuscular injection a fine wire percutaneous electrode in the target location and send the patient home with a cableless bandage mounted miniature stimulator and a set of power (battery) modules to deliver the appropriate dosage of stimulation per day. The use of percutaneous electrodes allows the selective, comfortable, and consistent recruitment of the muscle(s) into which the electrode(s) are implanted. The miniature stimulator will enhance the ease of use of electrical stimulation therapy, improving effectiveness and patient compliance.

Thesaurus Terms:
biomedical equipment development, implant, miniature biomedical equipment, neuromuscular stimulator, physical therapy, therapy design /development cost effectiveness, electrode, energy source, portable biomedical equipment bioengineering /biomedical engineering, medical implant science

Shoulder pain is a common complication following stroke, affecting almost one third of stroke survivors. Of the multitude of treatment options, only surface electrical stimulation has evidence of efficacy from multiple randomized controlled trials. However, clinical and technical difficulties associated with surface stimulation, such as discomfort caused by stimulation of cutaneous pain receptors and the need for skilled personnel to place the surface electrodes on a daily basis, have prevented it from becoming the standard of care. Percutaneous electrical stimulation is a promising treatment option, as demonstrated by clinical studies, but there are no commercially available systems. During the Phase I project period, the design concept for a novel percutaneous electrical stimulation system was completed and its technical feasibility was demonstrated. The objective of this Phase II project is to complete the design and development of the electrical stimulator and assess its usability, safety, and efficacy in a technical and clinical validation study. The specific aims of this project are to 1) complete the development of the stimulator housing and construction, 2) complete the development and testing of the stimulator's miniaturized circuit board and associated embedded software, and 3) conduct a clinical study to validate the usability, safety, and efficacy of the Neuropill System in eleven subjects with post-stroke shoulder pain. Our long term goal is to commercialize a safe and effective therapy for post-stroke shoulder pain. At the conclusion of this Phase II project, we will have completed the development of an innovative technology and evaluated its usability, safety, and efficacy for the treatment of post-stroke shoulder pain. Ultimately, the findings from this development effort and clinical validation study will enable us to design and initiate the larger clinical studies necessary for commercialization.

Public Health Relevance:
Present treatment options for post-stroke shoulder pain, affecting almost one third of stroke survivors, are either ineffective or have technical barriers preventing their widespread use. Percutaneous electrical stimulation is a promising treatment option, as demonstrated by clinical studies, but there are no commercially available systems. The Neuropill System is intended to provide electrical stimulation therapy to significantly reduce post-stroke shoulder pain, while offering significant advantages in comfort, patient compliance, and ease of use.

Thesaurus Terms:
Affect; Anodes; Apoplexy; Arm; Brief Pain Inventory; Care Givers; Caregivers; Cathodes; Cerebral Stroke; Cerebrovascular Apoplexy; Cerebrovascular Stroke; Cerebrovascular Accident; Characteristics; Clinical; Clinical Research; Clinical Study; Code; Coding System; Compliance Behavior; Complication; Computer Programs; Computer Simulation; Computer Software; Computerized Models; Custom; Cutaneous; Data; Deltoid; Development; Devices; Electric Stimulation; Electrical Stimulation; Electrodes; Evaluation; Fda; Focus Groups; Food And Drug Administration; Food And Drug Administration (U.S.); Fungi, Filamentous; Future; Goals; Home; Home Environment; Housing; Human Resources; Implant; Implanted Electrodes; Instruction; Intramuscular; Intramuscular Injections; Left; Location; Manpower; Mathematical Model Simulation; Mathematical Models And Simulations; Measures; Medical; Medical Device; Methods; Models, Computer; Modification; Molds; Motor; Muscle; Muscle Tissue; Outcome Measure; Pain; Painful; Patient Compliance; Patient Cooperation; Patients; Performance; Phase; Physicians; Printing; Procedures; Process; Production; Programs (Pt); Programs [publication Type]; Randomized Controlled Trials; Regulation; Reporting; Running; Safety; Secure; Shoulder; Shoulder Pain; Simulation, Computer Based; Skin; Software; Staging; Stroke; Structure Of Deltoid Muscle; Supraspinatus; Supraspinatus Muscle Structure; Surface; Survivors; System; System, Loinc Axis 4; Testing; Therapeutic; Treatment Compliance; Treatment Efficacy; Usfda; United States Food And Drug Administration; Upper Arm; Validation; Vascular Accident, Brain; Weight; Base; Brain Attack; Cerebral Vascular Accident; Commercialization; Compliance Cooperation; Computational Modeling; Computational Models; Computational Simulation; Computer Based Models; Computer Program/Software; Computerized Modeling; Computerized Simulation; Cost; Deltoid Muscle Structure; Design; Designing; Effective Therapy; Improved; In Silico; Innovative Technologies; Intramuscular Administration Of Drug; Miniaturize; Novel; Pain Receptor; Patient Adherence; Personnel; Post Stroke; Poststroke; Prevent; Preventing; Product Development; Programs; Prototype; Public Health Relevance; Randomized Controlled Study; Standard Of Care; Stroke; Success; Therapeutic Efficacy; Therapeutically Effective; Therapy Compliance; Therapy Cooperation; Tool; Treatment Site; Usability; Validation Studies; Verification And Validation; Virtual Simulation