CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
GiMer Medical MN 1000 External 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/NCT03543085
NCT03543085N/ACompleted
CompareCT.gov

A Single-arm, Open Label, Single Center, Prospective Study of Ultra-high Frequency (500 KHz) Spinal Cord Stimulation for Treatment of Chronic Back Pain or Lower Limb Pain

GiMer Medical·interventional·Posted Jun 1, 2018·Updated Oct 13, 2021

In Brief

A clinical study evaluating GiMer Medical MN 1000 External Stimulator for Pain, Chronic and 2 related conditions. Completed, enrolled 10 participants across 1 site.

Detailed Summary

This study is a prospective, single-arm, open label, single center to confirm the effectiveness and safety of an ultra-high frequency (500 KHz) spinal cord stimulation in patients with chronic back pain or lower limb pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Chronic, Pain, Back, Pain, Radiating
CountriesTaiwan
CollaboratorsChina Medical University Hospital

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 1, 2018
Enrollment StartApr 12, 2018
Primary CompletionOct 23, 2018
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 8.1 years ago

Interventions

GiMer Medical MN 1000 External Stimulatordevice

Trial stimulator (GiMer Medical Model 1000 External Stimulator) to generate pulsed ultrahigh frequency (\>200KHz) electrical stimulation, delivered via lead in epidural space, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range.