Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT06287736
Status
Recruiting
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Conditions

  • Diabetic Peripheral Neuropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Spinal Cord Stimulator Implantation (SCS) — DEVICE
    Spinal cord stimulator implantation is broken up into two parts. The first part involves placement of temporary SCS leads for a one-week trial. If the participants respond favorably to the SCS, then they will undergo the second part and the device is implanted

Study Details

This is a prospective randomized control trial. Participants enrolled into the study will be randomized into one of three groups, two of which are treatment groups and the third is a control group. A time course of measurements before and after spinal cord stimulation (SCS) treatment (where applicable) will assess pain, DPN severity, small fiber nerve activity, and metabolic health markers.

Key Dates

Start date
Apr 17, 2024
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • No Intervention: Conventional Medical Management (CMM). Group1
  • Active Comparator: Spinal Cord Stimulator (SCS) immediate activation. Group 2
  • Active Comparator: Spinal Cord Stimulator (SCS) Delayed activation. Group 3

Primary Outcome Measure

Change in Pain level [ Time Frame: 18 months post baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State University Wexner Medical CenterColumbusOhio43210
Uchechi Okafor
[email protected]
614-293-4876
Brian Dalm, MD (PRINCIPAL_INVESTIGATOR)
Kristy Townsend, PhD (SUB_INVESTIGATOR)
Magdalena Blaszkiewicz, PhD (SUB_INVESTIGATOR)
Miriam Freimer, MD (SUB_INVESTIGATOR)
Bakri Elsheikh, MD (SUB_INVESTIGATOR)

Find similar trials in Columbus, OH

By research site
The Ohio State University Wexner Medical Center· Columbus, OH

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