CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
High Frequency Spinal Cord Stimulatordevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03769675
NCT03769675N/ACompleted
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Quantitative Assessment of Painful Diabetic Peripheral Neuropathy After High Frequency Spinal Cord Stimulation: (QUANT) HF10 Study

Mayo Clinic·interventional·Posted Dec 7, 2018·Updated Apr 11, 2023

In Brief

A clinical study evaluating High Frequency Spinal Cord Stimulator for Painful Diabetic Neuropathy. Completed, enrolled 10 participants across 1 site.

Detailed Summary

Will participants with painful lower extremity diabetic peripheral neuropathy (DPN) that are treated with high frequency spinal cord stimulation (HF10 SCS) have improvements in lower extremity peripheral nerve function?

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPainful Diabetic Neuropathy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedDec 7, 2018
Enrollment StartNov 20, 2018
Primary CompletionApr 15, 2022
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 7.6 years ago

Interventions

High Frequency Spinal Cord Stimulatordevice

The SCS implant will follow standard clinical practice for these FDA approved indications. Two percutaneous leads will be placed in the posterior spinal epidural space under radiographic guidance and attached to either an external stimulator (trial phase) or a subcutaneously implanted impulse generator (IPG). Intraoperative impedance testing will be performed to ensure electrical integrity. Patients with HF10 SCS will receive 30 µs pulses delivered at 10,000 Hz with amplitude adjusted to optimal analgesic response. Programming will occur postoperatively and as needed based on patient feedback in standard clinic visits. .