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Device

Spinal Cord Stimulator (SCS) Delayed activation. Group 3 for Diabetic Neuropathy

N/A

Waitlist Available

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months post baseline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

change in neuropathic symptoms using Michigan Neuropathy Screening instrument

Trial Design

3Treatment groups

Active Control

Group I: Spinal Cord Stimulator (SCS) Delayed activation. Group 3Active Control1 Intervention

Group II: Spinal Cord Stimulator (SCS) immediate activation. Group 2Active Control1 Intervention

Group III: Conventional Medical Management (CMM). Group1Active Control1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Neuright, Inc.UNKNOWN

Ohio State UniversityLead Sponsor

829 Previous Clinical Trials

505,683 Total Patients Enrolled

Brian Dalm, MDPrincipal InvestigatorThe Ohio State University Wexner Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients in this ongoing clinical trial?

"Per information from clinicaltrials.gov, the current trial is not actively seeking participants. This particular study was first listed on March 1st, 2024 and last revised on February 23rd, 2024. While this specific research endeavor is not recruiting at present, there are a total of 158 alternative studies currently accepting enrollees."

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