BurstDR Stimulation for Painful Diabetic Neuropathy

Painful Diabetic Neuropathy Clinical Trial

Official title:

BurstDRTM Spinal Cord Dorsal Column Stimulation for Painful Diabetic Neuropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05985291
• Other study ID #: 23-817
• Status: Recruiting
• Start date: July 3, 2023
• Est. completion date: October 3, 2025

Study information

• Verified date: August 2023
• Source: Aurora Health Care
• Contact: Merve Buluk Figueira, MS
• Phone: 9204561551
• Email: merve.figueira[@]aah.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 3, 2025
• Est. primary completion date: July 3, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

• Have prior experience with SCS, dorsal root ganglion (DRG) stimulation, peripheral nerve field stimulation (PNfS), or peripheral nerve stimulation (PNS) for chronic intractable pain

• 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 a local infection at the anticipated surgical entry site or an active systemic infection

• 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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Pain
• Painful Diabetic Neuropathy

Intervention

Combination Product:
• SCS in combination with CMM
Subjects receiving BurstDR spinal cord dorsal column stimulation in combination with conservative medical management for the treatment of painful diabetic neuropathy as part of regular medical care.

Locations

Country	Name	City	State
United States	Aurora Health Oshkosh	Oshkosh	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Aurora Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of patients with change from baseline in sensory neurological assessment at 3 months	Assessed by the healthcare provider.	3 months
Other	Average change from baseline to 3 months in severity of neuropathic pain as measured by Neuropathic Pain 4 Questions (DN4) (0-10)	score of 4 or greater indicates neuropathic pain	3 months
Other	Average change from baseline in CGM metrics from AGP report at 3 months		3 months
Other	Average change from baseline in health-related quality of life at 3 months as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS-29)		3 months
Other	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		6 months
Other	Average change in health-related quality of life as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS-29) at 6 months		6 months
Other	Average change from baseline to 3 months in opioid dosage measured in total morphine milligram equivalents (MME)		3 months
Other	Proportion of participants with clinically meaningful improvement on sensory neurological examination as determined by the investigator at 6 months compared to baseline.		6 months
Other	Average change from baseline to 6 months in opioid dosage measured in total MME		6 months
Other	Average change from baseline to 6 months in severity of neuropathic pain as measured by DN4		6 months
Other	Difference in average percentage change from baseline in CGM metrics from AGP report at 6 months		6 months
Other	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.		3 & 6 months
Primary	Average change from baseline to 3 months in treatment responder rates	Responder is defined as a subject who has at least 50% reduction in lower limb pain from baseline as measured by a 10 cm Visual Analog Scale (VAS).	3 months
Secondary	Average change from baseline to 6 months in treatment responder rates assessed by Visual Analog Scale (0-10 cm)	0 no pain at all, 10 worse pain imaginable	6 months