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Device

Spinal Cord Stimulation for Peripheral Neuropathy

N/A
Recruiting
Led By Brian Dalm, MD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months post baseline
Awards & highlights
No Placebo-Only Group

Summary

This trial will randomly assign participants to one of three groups: two treatment groups and one control group. They will measure pain, severity of diabetic peripheral neuropathy (DPN), nerve activity, and metabolic

Who is the study for?
This trial is for individuals with diabetic neuropathy or peripheral neuropathy, which are conditions causing nerve pain and damage. Participants should be adults who can give informed consent and have a history of chronic pain despite treatment. They must not have any contraindications to SCS therapy.
What is being tested?
The study tests Spinal Cord Stimulator (SCS) Implantation's effectiveness in reducing pain and improving nerve function in patients with nerve damage from diabetes or other causes. It randomly assigns participants into two treatment groups or one control group to compare outcomes.
What are the potential side effects?
Potential side effects of SCS may include discomfort at the implant site, infection, bleeding, headache, allergic reaction to materials used in the device, and temporary pain increase.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months post baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months post baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Diabetic Peripheral Neuropathy (DPN) Pain using the Neuropathic pain diagnostic questionnaire (DN4)
Change in PROMIS quality of life in relation to pain level
Change in Pain level
Secondary study objectives
change in neuropathic symptoms using Michigan Neuropathy Screening instrument

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: Spinal Cord Stimulator (SCS) immediate activation. Group 2Active Control1 Intervention
Group II: Spinal Cord Stimulator (SCS) Delayed activation. Group 3Active Control1 Intervention
Group III: Conventional Medical Management (CMM). Group1Active Control1 Intervention

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Who is running the clinical trial?

Neuright, Inc.UNKNOWN
Ohio State UniversityLead Sponsor
871 Previous Clinical Trials
655,912 Total Patients Enrolled
Brian Dalm, MDPrincipal InvestigatorThe Ohio State University Wexner Medical Center
~36 spots leftby Dec 2025
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