Clinical Trials

Current Enrolling Trials*

Most of our Research Studies do reimburse for time and travel for participation.

You may be eligible to participate in one of our studies if you qualify.

RELIEF

A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain (RELIEF)

To compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice, when used according to the applicable Directions for Use

– and –

To evaluate the economic value and technical performance of Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice

ELIGIBILITY

Key Inclusion Criteria:

  • 18 Years and Older
  • Study candidate is scheduled to be trialed, on-label, with a commercially approved Boston Scientific neurostimulation system for pain, per local directions for use
  • Signed a valid, IRB/EC-approved informed consent form

Key Exclusion Criteria:

  • Contraindicated for Boston Scientific neurostimulation system
  • Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate’s ability to assess pain relief or to complete study assessments

WHISPER

Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude (WHISPER)

To demonstrate sustained clinically significant pain relief in patients with chronic pain when using the Boston Scientific Precision Spinal Cord Stimulator (SCS) System at subperception amplitude

ELIGIBILITY

Key Inclusion Criteria:

  • Ages 22- older

  • Complaint of chronic pain of the trunk and/or limbs

  • Willing and able to comply with all protocol-required procedures and assessments/evaluations; able to independently read and complete all questionnaires and assessments provided in English

  • Subject signed a valid, IRB-approved informed consent form (ICF) provided in English

Key Exclusion Criteria:

  • Meets any contraindication in the Precision SCS system per locally applicable Directions for Use (DFU)
  • Any pain-related diagnosis or medical/psychological condition that, in the clinician’s best judgment, might confound reporting of study outcomes

Therapy for the Treatment of Chronic, Focal, Neuropathic Pain Following Surgical Intervention

A Multicenter Prospective Clinical Trial

The purpose of this investigational study is to document the safety and effectiveness of HF10 therapy delivered to the spinal cord in subjects with chronic, focal, neuropathic pain subsequent to surgery of the trunk or the limb(s). This study is a multi-center, prospective evaluation a SCS System with the subject as their own control. Outcomes will be assessed via standardized tests.

ELIGIBILITY

Key Inclusion Criteria:

  • Have been diagnosed with chronic, focal, neuropathic pain following surgery of the trunk or the limb(s).

  • Average pain intensity (over a period of 7 days) of ≥5 out 10 cm on the Visual Analog Scale (VAS) in the primary area of pain at enrollment.

  • Have stable neurological status measured by motor, sensory and reflex function as determined by the investigator

Key Exclusion Criteria:

  • Have chronic back or trunk pain resulting from failed back surgery.

  • Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator (such as primary headache diagnosis or fibromyalgia).

  • Have a current diagnosis of a progressive neurological disease such as multiple sclerosis (MS), chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome, acute herniating disc, severe spinal stenosis and brachial plexus avulsion as determined by the Investigator.

  • Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure as determined clinically by the Investigator.

  • Have any prior experience with SCS.

A Prospective Clinical Trial to Assess the Feasibility a  Spinal Cord Stimulation (SCS) System in the Treatment of Chronic Peripheral Polyneuropathy of the Upper or Lower Limb(s)

The purpose of this investigational study is to assess the feasibility (safety and effectiveness) of therapy delivered to the spinal cord in subjects with peripheral polyneuropathy of the upper or the lower limb(s). This study is a prospective evaluation an SCS System with the subject as their own control.

ELIGIBILITY

Key Inclusion Criteria:

  • Clinical diagnosis of peripheral polyneuropathy of the upper or the lower limb(s), which has been refractory to conservative therapy for a minimum of 3 months. Previous conservative therapy includes pain medications (TCAs, Pregabalin, Gabapentin), and may include other treatment modalities such as nerve root blocks, RF or pRF ablation, or TENS.

  • Average pain intensity (over a period of 7 days) of ≥5 out 10 cm on the Visual Analog Scale (VAS) in the primary area of pain at enrollment (may be either upper or lower limbs but not both).

  • Be on stable pain medications, as determined by the Investigator, for at least 28 days prior to assessing pain intensity as described in inclusion criterion #2, and be willing to stay on those medications with no dose adjustments until activation of the permanently implanted SCS device.

  • Be 18 years of age or older at the time of enrollment.

  • Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician.

  • Average pain intensity (over a period of 7 days) of ≥5 out 10 cm on the Visual Analog Scale (VAS) in the primary area of pain at enrollment.

  • Have stable neurological status measured by motor, sensory and reflex function as determined by the investigator

Key Exclusion Criteria:

  • Have a diagnoses of a mononeuropathy (e.g., causalgias, carpal tunnel syndrome, ulnar, radial, tibial, peroneal neuropathies), or neuropathies of the trunk (e.g., post-herpetic neuralgia).

  • Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator (such as primary headache diagnosis and fibromyalgia).

  • Have a current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome, Complex regional Pain Syndrome, acute herniating disc, severe spinal stenosis and brachial plexus avulsion as determined by the Investigator.

*for full eligibility (inclusion/exclusion) criteria contact
Brenda (816) 767-3257 

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