Clinical trial NCT05985291: BurstDR Stimulation for Painful Diabetic Neuropathy
Official title: BurstDRTM Spinal Cord Dorsal Column Stimulation for Painful Diabetic Neuropathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Painful Diabetic Neuropathy
Keywords: neurostimulation
spinal cord stimulation
burst stimulation
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 40
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will include patients older than 21 suffering from Painful Diabetic Neuropathy.

Brief summary: This study aims to demonstrate treatment outcomes of Painful Diabetic Neuropathy (PDN) patients treated with BurstDRTM Spinal Cord Dorsal Column Stimulator (SCS) along with conservative medical management per standard of care.

Detailed description: In this study, we aim to systematically collect real world, observational and prospective data on the safety and effectiveness of an SCS system for the management of PDN. This study will provide, to the best of our knowledge, the first clinical, real world, prospective data in treatment of PDN with an SCS system.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of lower extremity Painful Diabetic Neuropathy (PDN) with symptoms for at least a year prior to signing the consent form
* PDN refractory to FDA approved medications: duloxetine, pregabalin, tapentadol, and capscaicin
* Lower limb pain intensity of 5 cm or more on a 10-cm visual analogue scale (VAS)
* HbA1c ≤10%
* BMI \<45 kg/m2
* Be 22 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
* Be capable of subjective evaluation, able to read and understand English-written questionnaires, and able to read, understand and sign the written informed consent in English
* Be willing and capable of giving informed consent
* Be willing and able to comply with study-related requirements, procedures, and scheduled visits
* Have adequate cognitive ability to use a patient programmer and recharger as determined by the Investigator
* Be on a stable analgesic regimen, as determined by the Investigator, for at least 30 days prior to assessing pain intensity, and be willing to stay on those medications with no dose adjustments until activation of the permanently implanted SCS device
* Have stable neurological status measured by motor, sensory and reflex function as determined by the investigator

Exclusion Criteria:

* Current daily opioid dosage greater than 120 mg morphine equivalents
* Have an average pain intensity of ≥ 3 out of 10 cm on the VAS in the upper extremities due to diabetic neuropathy at enrollment
* Have a diagnosis of a lower limb mononeuropathy (e.g., causalgia and tibial or peroneal neuropathies), have had a lower limb amputation other than toes due to diabetes, or have large (≥3 cm) and/or gangrenous ulcers of the lower limbs.
* 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 injury, as determined by the Investigator
* Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, low platelet count, severely diminished functional capacity due to underlying cardiac/pulmonary disease, symptomatic uncontrolled hypertension, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure, as determined clinically by the Investigator
* Be benefitting from an interventional procedure and/or surgery to treat lower limb pain (Subjects should be enrolled at least 30 days from last benefit).
* Have an existing intrathecal pain pump and/or another active implantable device such as a pacemaker
* Have a condition currently requiring or likely to require the use of diathermy or MRI that is inconsistent with ProclaimTM system guidelines in the Physician's Manual
* Have either a metastatic malignant neoplasm or untreated local malignant neoplasm
* Have a life expectancy of less than one year
* Have within 6 months of enrollment a significant untreated addiction to dependency producing medications, alcohol or illicit drugs
* Be concomitantly participating in another clinical study
* Be involved in an injury claim under current litigation
* Be a recipient of temporary Social Security Disability Insurance (SSDI) benefits due to chronic pain
* Have a pending or approved worker's compensation claim
* Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance with intervention and/or ability to evaluate treatment outcome, as determined by a psychologist in the last 12 months

Primary outcomes:
measure: Average change from baseline to 3 months in treatment responder rates
timeFrame: 3 months
Secondary outcomes:
measure: Average change from baseline to 6 months in treatment responder rates assessed by Visual Analog Scale (0-10 cm)
timeFrame: 6 months
Other outcomes:
measure: Percentage of patients with change from baseline in sensory neurological assessment at 3 months
timeFrame: 3 months
measure: Average change from baseline to 3 months in severity of neuropathic pain as measured by Neuropathic Pain 4 Questions (DN4) (0-10)
timeFrame: 3 months
measure: Average change from baseline in CGM metrics from AGP report at 3 months
timeFrame: 3 months
measure: Average change from baseline in health-related quality of life at 3 months as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS-29)
timeFrame: 3 months
measure: Average change in proportion of remitters (remission is defined as having a lower limb pain Visual Analog Score score ≤ 2.5 cm) at 6 months
timeFrame: 6 months
measure: Average change in health-related quality of life as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS-29) at 6 months
timeFrame: 6 months
measure: Average change from baseline to 3 months in opioid dosage measured in total morphine milligram equivalents (MME)
timeFrame: 3 months
measure: Proportion of participants with clinically meaningful improvement on sensory neurological examination as determined by the investigator at 6 months compared to baseline.
timeFrame: 6 months
measure: Average change from baseline to 6 months in opioid dosage measured in total MME
timeFrame: 6 months
measure: Average change from baseline to 6 months in severity of neuropathic pain as measured by DN4
timeFrame: 6 months
measure: Difference in average percentage change from baseline in CGM metrics from AGP report at 6 months
timeFrame: 6 months
measure: Assessment of subject outcomes satisfaction as measured through Patient Global Impression of Change (PGIC) (1-7 where higher scores mean better outcome) at 3 months and 6 months.
timeFrame: 3 & 6 months
Locations:
city: Oshkosh
country: United States
facility: Aurora Health Oshkosh
state: Wisconsin
Study officials:
affiliation: Aurora Healthcare
name: Mansoor Aman, MD
role: PRINCIPAL_INVESTIGATOR
References: